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1.
Expert Rev Clin Pharmacol ; 13(2): 103-113, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31951778

RESUMO

Introduction: Treatment options for COPD have evolved rapidly in the last decade and inhaled bronchodilators have largely supplanted the use of oral bronchodilators because of their increased efficacy and excellent safety with topical delivery to the lung. Recently added to the therapeutic armamentarium are fixed-dose combinations (FDC) of two long acting bronchodilators. LAMAs (long acting muscarinic antagonists) and LABAs (long acting beta agonists) are the main classes available and use different pathways to effectively produce bronchial smooth muscle relaxation.Areas covered: The most recent inhaled FDC LAMA/LABA to come to market is Aclidinium Bromide and Formoterol Fumarate. We searched databases of PubMed, Cochrane Library, and manufacturers' websites and retrieved all the randomized-controlled trials (RCTs) conducted with these drugs up to September 2019.Expert opinion: It is likely that FDCs will become the core of our COPD pharmacotherapy for all but the mildest COPD patients. These individual drugs have excellent efficacy and safety records for the maintenance treatment of COPD. Studies have demonstrated that twice daily treatment with aclidinium/formoterol resulted in significant improvement in lung function and an improved exercise tolerance when compared to placebo. Adverse effects are within the range of what is seen with other LAMA/LABA combinations.


Assuntos
Fumarato de Formoterol/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Tropanos/administração & dosagem , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/farmacologia , Broncodilatadores/administração & dosagem , Broncodilatadores/efeitos adversos , Broncodilatadores/farmacologia , Combinação de Medicamentos , Fumarato de Formoterol/efeitos adversos , Fumarato de Formoterol/farmacologia , Humanos , Antagonistas Muscarínicos/administração & dosagem , Antagonistas Muscarínicos/efeitos adversos , Antagonistas Muscarínicos/farmacologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Tropanos/efeitos adversos , Tropanos/farmacologia
2.
Pharm Res ; 37(3): 38, 2020 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-31965333

RESUMO

PURPOSE: Asthma is a prevalent lung disorder that cause heavy burdens globally. Inhalation medicaments can relieve symptoms, improve lung function and, thus, the quality of life. However, it is well-documented that patients often do not get the prescribed dose out of an inhaler and the deposition of drug is suboptimal, due to incorrect handling of the device and wrong inhalation technique. This study aims to design and fabricate an acoustic dry powder inhaler (ADPI) for monitoring inhalation flow and related drug administration in order to evaluate whether the patient receives the complete dose out of the inhaler. METHODS: The devices were fabricated using 3D printing and the impact of the acoustic element geometry and printing resolution on the acoustic signal was investigated. Commercial Foradil (formoterol fumarate) capsules were used to validate the availability of the ADPI for medication dose tracking. The acoustic signal was analysed with Partial-Least-Squares (PLS) regression. RESULTS: Indicate that specific acoustic signals could be generated at different air flow rates using a passive acoustic element with specific design features. This acoustic signal could be correlated with the PLS model to the air flow rate. A more distinct sound spectra could be acquired at higher printing resolution. The sound spectra from the ADPI with no capsule, a full capsule and an empty capsule are different which could be used for medication tracking. CONCLUSIONS: This study shows that it is possible to evaluate the medication quality of inhaled medicaments by monitoring the acoustic signal generated during the inhalation process.


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/química , Inaladores de Pó Seco/instrumentação , Fumarato de Formoterol/química , Impressão Tridimensional , Acústica , Administração por Inalação , Asma/fisiopatologia , Broncodilatadores/administração & dosagem , Sistemas de Liberação de Medicamentos/instrumentação , Desenho de Equipamento/instrumentação , Fumarato de Formoterol/administração & dosagem , Humanos , Análise dos Mínimos Quadrados , Pulmão/metabolismo , Monitorização Fisiológica/instrumentação , Pós/química , Pós/farmacologia , Análise de Regressão , Som
3.
Lancet ; 394(10210): 1737-1749, 2019 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-31582314

RESUMO

BACKGROUND: To date, no studies have assessed the efficacy of single-inhaler triple therapy in asthma. Here we report on two studies that compared the single-inhaler extrafine combination of beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF; long-acting ß2 agonist), and glycopyrronium (G; long-acting muscarinic antagonist) with the combination of BDP with FF. METHODS: Two parallel-group, double-blind, randomised, active-controlled, phase 3 trials (Triple in Asthma With Uncontrolled Patients on Medium Strength of ICS + LABA [TRIMARAN] and Triple in Asthma High Strength Versus ICS/LABA HS and Tiotropium [TRIGGER]) recruited patients from 171 sites across 16 countries (TRIMARAN), and from 221 sites across 17 countries (TRIGGER). The sites were a mixture of secondary and tertiary care centres and specialised investigation units. Eligible patients were adults (aged 18-75 years) with uncontrolled asthma, a history of one or more exacerbations in the previous year, and previously treated with inhaled corticosteroid (TRIMARAN: medium dose; TRIGGER: high dose) plus a long-acting ß2 agonist. Enrolled patients were initially treated with BDP/FF (TRIMARAN: 100 µg BDP and 6 µg FF; TRIGGER: 200 µg BDP and 6 µg FF) for 2 weeks, then randomly assigned to treatment using an interactive response technology system with a balanced block randomisation scheme stratified by country. Patients, investigators, site staff, and sponsor staff were masked to BDP/FF/G and BDP/FF assignment. In TRIMARAN, patients were randomly assigned (1:1) to 52 weeks of BDP/FF/G (100 µg BDP, 6 µg FF, and 10 µg G) or BDP/FF (100 µg BDP and 6 µg FF), two inhalations twice daily. In TRIGGER, patients were randomly assigned (2:2:1) to 52 weeks of BDP/FF/G (200 µg BDP, 6 µg FF, and 10 µg G) or BDP/FF (200 BDP and 6 µg FF), both two inhalations twice daily, or open-label BDP/FF (200 µg BDP and 6 µg FF) two inhalations twice daily plus tiotropium 2·5 µg two inhalations once daily. Coprimary endpoints for both trials (BDP/FF/G vs BDP/FF) were pre-dose forced expiratory volume in 1 s (FEV1) at week 26 and rate of moderate and severe exacerbations over 52 weeks. Safety was assessed in all patients who received at least one dose of study treatment. These trials were registered with ClinicalTrials.gov, NCT02676076 (TRIMARAN), NCT02676089 (TRIGGER). FINDINGS: Between Feb 17, 2016, and May 17, 2018, 1155 patients in TRIMARAN were given BDP/FF/G (n=579) or BDP/FF (n=576). Between April 6, 2016, and May 28, 2018, 1437 patients in TRIGGER were given BDP/FF/G (n=573), BDP/FF (n=576), or BDP/FF plus tiotropium (n=288). Compared with the BDP/FF group, week 26 predose FEV1 improved in the BDP/FF/G group by 57 mL (95% CI 15-99; p=0·0080) in TRIMARAN and by 73 mL (26-120; p=0·0025) in TRIGGER, with reductions in the rate of moderate and severe exacerbations of 15% (rate ratio 0·85, 95% CI 0·73-0·99; p=0·033) in TRIMARAN and 12% (0·88, 0·75-1·03; p=0·11) in TRIGGER. Four patients had treatment-related serious adverse events, one in TRIMARAN in the BDP/FF/G group and three in TRIGGER-one in the BDP/FF/G and two in the BDP/FF group. Three patients in the BDP/FF/G group in TRIMARAN and two patients in TRIGGER-one in the BDP/FF/G group and one in the BDP/FF group-had adverse events leading to death. None of the deaths were considered as related to treatment. INTERPRETATION: In uncontrolled asthma, addition of a long-acting muscarinic antagonist to inhaled corticosteroid plus long-acting ß2-agonist therapy improves lung function and reduces exacerbations. FUNDING: Chiesi Farmaceutici.


Assuntos
Asma/tratamento farmacológico , Beclometasona/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Glicopirrolato/administração & dosagem , Administração por Inalação , Adulto , Idoso , Beclometasona/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Combinação de Medicamentos , Feminino , Fumarato de Formoterol/uso terapêutico , Glicopirrolato/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Centros de Cuidados de Saúde Secundários , Centros de Atenção Terciária , Resultado do Tratamento , Adulto Jovem
4.
Clin Drug Investig ; 39(10): 991-1001, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31332649

RESUMO

BACKGROUND AND OBJECTIVES: A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair®, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair® in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease. METHODS: A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated. RESULTS: The mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). The FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each). CONCLUSIONS: Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair® in patients with chronic obstructive pulmonary disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03028701.


Assuntos
Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Inaladores de Pó Seco/métodos , Fumarato de Formoterol/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Idoso , Sistemas de Liberação de Medicamentos/métodos , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Testes de Função Respiratória/métodos , Índice de Gravidade de Doença , Resultado do Tratamento
5.
Int J Chron Obstruct Pulmon Dis ; 14: 1019-1031, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31190787

RESUMO

Purpose: Global evidence-based treatment strategies for chronic obstructive pulmonary disease (COPD) recommend using long-acting bronchodilators (LABDs) as maintenance therapy. However, COPD patients are often undertreated. We examined COPD treatment patterns among Medicare beneficiaries who initiated arformoterol tartrate, a nebulized long-acting beta2 agonist (LABA), and identified the predictors of initiation. Methods: Using a 100% sample of Medicare administrative data, we identified beneficiaries with a COPD diagnosis (ICD-9 490-492.xx, 494.xx, 496.xx) between 2010 and 2014 who had ≥1 year of continuous enrollment in Parts A, B, and D, and ≥2 COPD-related outpatient visits within 30 days or ≥1 hospitalization(s). After applying inclusion/exclusion criteria, three cohorts were identified: (1) study group beneficiaries who received nebulized arformoterol (n=11,886), (2) a subset of the study group with no LABD use 90 days prior to initiating arformoterol (n=5,542), and (3) control group beneficiaries with no nebulized LABA use (n=220,429). Logistic regression was used to evaluate predictors of arformoterol initiation. Odds ratios (ORs), 95% confidence intervals (CIs), and p values were computed. Results: Among arformoterol users, 47% (n=5,542) had received no LABDs 90 days prior to initiating arformoterol. These beneficiaries were being treated with a nebulized (50%) or inhaled (37%) short-acting bronchodilator or a systemic corticosteroid (46%), and many received antibiotics (37%). Compared to controls, beneficiaries who initiated arformoterol were significantly more likely to have had an exacerbation, a COPD-related hospitalization, and a pulmonologist or respiratory therapist visit prior to initiation (all p<0.05). Beneficiaries with moderate/severe psychiatric comorbidity or dual-eligible status were significantly less likely to initiate arformoterol, as compared to controls (all p<0.05). Conclusion: Medicare beneficiaries who initiated nebulized arformoterol therapy had more exacerbations and hospitalizations than controls 90 days prior to initiation. Findings revealed inadequate use of maintenance medications, suggesting a lack of compliance with evidence-based treatment guidelines.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Broncodilatadores/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Pulmão/efeitos dos fármacos , Medicare , Conduta do Tratamento Medicamentoso/tendências , Padrões de Prática Médica/tendências , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Demandas Administrativas em Assistência à Saúde , Aerossóis , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Progressão da Doença , Feminino , Fidelidade a Diretrizes/tendências , Hospitalização , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Nebulizadores e Vaporizadores , Guias de Prática Clínica como Assunto , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
6.
Ter Arkh ; 91(3): 76-85, 2019 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-31094464

RESUMO

Currently, combinations of long-acting beta2-agonists and long-acting anticholinergics are considered as the basic therapy for majority of patients with chronic obstructive pulmonary disease (COPD). These combinations have different pharmacological characteristics and delivery devices that provides different clinical effects and new opportunities for personalized treatment of COPD. Aclidinium/formoterol fixed combination differs from other dual bronchodilators by twice-daily dosing regimen, good safety profile and a specific delivery system. Recent information on clinical efficacy and safety of aclidinium/formoterol combination in COPD patients is given in this article.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Broncodilatadores/uso terapêutico , Fumarato de Formoterol/uso terapêutico , Pulmão/efeitos dos fármacos , Antagonistas Muscarínicos/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Tropanos/uso terapêutico , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Broncodilatadores/administração & dosagem , Broncodilatadores/efeitos adversos , Combinação de Medicamentos , Fumarato de Formoterol/administração & dosagem , Fumarato de Formoterol/efeitos adversos , Humanos , Pulmão/fisiopatologia , Antagonistas Muscarínicos/administração & dosagem , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Resultado do Tratamento , Tropanos/administração & dosagem , Tropanos/efeitos adversos
7.
Ther Adv Respir Dis ; 13: 1753466619850725, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31096854

RESUMO

Aclidinium bromide/formoterol fumarate (AB/FF) 400/12 µg is a twice-daily long-acting muscarinic receptor antagonist and long-acting ß2 agonist (LAMA/LABA) dual-bronchodilator maintenance therapy used to relieve symptoms and reduce future risk of exacerbations in adults with chronic obstructive pulmonary disease (COPD). To date, there have been several clinical studies and post hoc analyses of AB/FF, assessing treatment outcomes in patients with moderate-to-severe COPD. These studies have looked at a range of outcomes, including lung function parameters, patient-reported symptom scores, quality-of-life measures assessing impaired health and perceived well-being, and the frequency, duration, and severity of exacerbations. In light of the major 2017 revision to the Global initiative for chronic Obstructive Lung Disease (GOLD) recommendations, and the subsequent updates, we present an update on the latest evidence supporting the efficacy and safety of AB/FF. This review discusses the clinical relevance of the improvements in lung function, symptoms, quality of life, and exacerbations in patients with COPD reported in the phase III and IV trials of AB/FF. Given the current concerns over unnecessary inhaled corticosteroid (ICS) use in COPD, we also touch briefly on the use of blood eosinophils as a biomarker for identifying those patients with COPD already using LAMA/LABA therapy for whom the addition of ICS might be of benefit.


Assuntos
Fumarato de Formoterol/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Tropanos/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/farmacologia , Adulto , Broncodilatadores/administração & dosagem , Broncodilatadores/farmacologia , Combinação de Medicamentos , Fumarato de Formoterol/farmacologia , Humanos , Antagonistas Muscarínicos/administração & dosagem , Antagonistas Muscarínicos/farmacologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Índice de Gravidade de Doença , Tropanos/farmacologia
8.
N Engl J Med ; 380(21): 2020-2030, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31112386

RESUMO

BACKGROUND: In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting ß2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial. METHODS: We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 µg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 µg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 µg of budesonide and 6 µg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations. RESULTS: The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 µg per day in the budesonide-formoterol group and 222±113 µg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use. CONCLUSIONS: In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).


Assuntos
Albuterol/administração & dosagem , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Budesonida/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Adulto , Idoso , Albuterol/efeitos adversos , Broncodilatadores/efeitos adversos , Budesonida/efeitos adversos , Quimioterapia Combinada , Feminino , Fumarato de Formoterol/efeitos adversos , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade
9.
Artigo em Inglês | MEDLINE | ID: mdl-30962681

RESUMO

Background: AMPLIFY assessed the efficacy and safety of aclidinium bromide/formoterol fumarate (AB/FF) vs its monocomponents and tiotropium (TIO) in patients with moderate-to-very severe symptomatic COPD (NCT02796677). Methods: In this 24-week, Phase III, double-dummy, active-controlled study, symptomatic patients (COPD Assessment Test score ≥10) were randomized to twice-daily AB/FF 400/12 µg, AB 400 µg, or FF 12 µg, or once-daily TIO 18 µg. Co-primary endpoints were change from baseline at week 24 in 1-hour morning post-dose FEV1 (AB/FF vs AB) and in pre-dose (trough) FEV1 (AB/FF vs FF). Non-inferiority of AB vs TIO in pre-dose FEV1 was also an objective. Normalized area under the curve (AUC)0-3/3 h FEV1 and nighttime and early morning symptoms were also assessed. A subgroup participated in a 24-hour serial spirometry sub-study. Results: A total of 1,594 patients were randomized; 566 entered the sub-study. At week 24, 1-hour post-dose FEV1 significantly improved with AB/FF vs AB, FF, and TIO (84, 84, and 92 mL; all P<0.0001). AB/FF significantly improved trough FEV1 vs FF (55 mL, P<0.001) and AB was non-inferior to TIO. AB/FF significantly improved AUC0-3/3 h FEV1 vs all comparators (P<0.0001) and provided significant improvements in early morning symptoms vs TIO. The 24-hour spirometry demonstrated significantly greater improvements with AB/FF in AUC12-24/12 h vs all comparators, and in AUC0-24/24 h vs FF or TIO at week 24. Conclusion: In patients with moderate-to-very severe symptomatic COPD, twice-daily AB/FF significantly improved lung function vs monocomponents and TIO, and early morning symptom control vs TIO.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Broncodilatadores/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Pulmão/efeitos dos fármacos , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Brometo de Tiotrópio/administração & dosagem , Tropanos/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Idoso , Broncodilatadores/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Europa (Continente) , Feminino , Volume Expiratório Forçado , Fumarato de Formoterol/efeitos adversos , Humanos , Israel , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Fatores de Tempo , Brometo de Tiotrópio/efeitos adversos , Resultado do Tratamento , Tropanos/efeitos adversos , Estados Unidos , Capacidade Vital
10.
Artigo em Inglês | MEDLINE | ID: mdl-30880938

RESUMO

Background: Aclidinium/formoterol 400/12 µg is a twice-daily maintenance bronchodilator for COPD. This post hoc study evaluated aclidinium/formoterol vs aclidinium 400 µg, formoterol 12 µg, or placebo in patient subgroups. Patients and methods: Data were pooled from two 24-week Phase III clinical trials (ACLIFORM and AUGMENT). Patients (N=3,394) were analyzed by baseline airflow obstruction severity (moderate/severe), age (<65/≥65 years), sex, and exacerbation history (0/≥1 exacerbation in the previous 12 months). Changes from baseline vs placebo and mono-therapies were evaluated: morning pre-dose (trough) and morning 1-hour post-dose FEV1, Transition Dyspnea Index (TDI), and moderate/severe exacerbation rates (healthcare resource utilization [HCRU] and EXAcerbations of Chronic pulmonary disease Tool [EXACT] criteria). Results: Aclidinium/formoterol improved the post-dose FEV1 vs placebo and monotherapy in all subgroups (all P<0.01) and trough FEV1 vs placebo (P<0.001) and formoterol (P<0.05) across all subgroups. Improvements in trough FEV1 were observed vs aclidinium in patients with severe airflow obstruction, patients aged <65 years, males, and patients with exacerbation history (P<0.05). Improvements in TDI were observed vs placebo in all subgroups (all P<0.001), monotherapies for patients with moderate (formoterol P<0.05) or severe airflow obstruction (aclidinium P<0.05), patients aged <65 years (aclidinium P<0.01, formoterol P<0.05), males (formoterol P<0.05), and patients with no exacerbation history (formoterol P<0.05). HCRU exacerbation rates were lower for aclidinium/formoterol vs placebo in patients with no exacerbation history (P<0.01). EXACT exacerbation rates were lower for aclidinium/formoterol in patients with moderate airflow obstruction vs placebo and aclidinium, patients aged <65 years vs placebo and ≥65 years vs formoterol, males vs placebo, and patients with no exacerbation history vs placebo (all P<0.05). Conclusion: Aclidinium/formoterol significantly improved post-dose FEV1, trough FEV1, and TDI vs placebo across all subgroups and vs monotherapy in many subgroups. These findings further support the benefits of aclidinium/formoterol for all patients with COPD.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Broncodilatadores/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Pulmão/efeitos dos fármacos , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Tropanos/administração & dosagem , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Fatores Etários , Idoso , Broncodilatadores/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Progressão da Doença , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , Fumarato de Formoterol/efeitos adversos , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento , Tropanos/efeitos adversos
11.
Artigo em Inglês | MEDLINE | ID: mdl-30880943

RESUMO

Background: Current pharmacological therapies for COPD improve quality of life and symptoms and reduce exacerbations. Given the progressive nature of COPD, it is arguably more important to understand whether the available therapies are able to delay clinical deterioration; the concept of "clinically important deterioration" (CID) has therefore been developed. We evaluated the efficacy of the single-inhaler triple combination beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G), using data from three large 1-year studies. Methods: The studies compared BDP/FF/G to BDP/FF (TRILOGY), tiotropium (TRINITY), and indacaterol/glycopyrronium (IND/GLY; TRIBUTE). All studies recruited patients with symptomatic COPD, FEV1 <50%, and an exacerbation history. We measured the time to first CID and to sustained CID, an endpoint combining FEV1, St George's Respiratory Questionnaire (SGRQ), moderate-to-severe exacerbations, and death. The time to first CID was based on the first occurrence of any of the following: a decrease of ≥100 mL from baseline in FEV1, an increase of ≥4 units from baseline in SGRQ total score, the occurrence of a moderate/severe COPD exacerbation, or death. The time to sustained CID was defined as: a CID in FEV1 and/or SGRQ total score maintained at all subsequent visits, an exacerbation, or death. Results: Extrafine BDP/FF/G significantly extended the time to first CID vs BDP/FF (HR 0.61, P<0.001), tiotropium (0.72, P<0.001), and IND/GLY (0.82, P<0.001), and significantly extended the time to sustained CID vs BDP/FF (HR 0.64, P<0.001) and tiotropium (0.80, P<0.001), with a numerical extension vs IND/GLY. Conclusion: In patients with symptomatic COPD, FEV1 <50%, and an exacerbation history, extrafine BDP/FF/G delayed disease deterioration compared with BDP/FF, tiotropium, and IND/GLY. Trial registration: The studies are registered in ClinicalTrials.gov: TRILOGY, NCT01917331; TRINITY, NCT01911364; TRIBUTE, NCT02579850.


Assuntos
Corticosteroides/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Beclometasona/administração & dosagem , Broncodilatadores/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Glicopirrolato/administração & dosagem , Pulmão/efeitos dos fármacos , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Corticosteroides/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Idoso , Beclometasona/efeitos adversos , Broncodilatadores/efeitos adversos , Progressão da Doença , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , Fumarato de Formoterol/efeitos adversos , Glicopirrolato/efeitos adversos , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/efeitos adversos , Nebulizadores e Vaporizadores , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
12.
Drug Test Anal ; 11(7): 950-956, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30865387

RESUMO

Formoterol is a long-acting beta2-adrenoceptor agonist (LABA) used for the treatment of asthma and exercise-induced bronchoconstriction. Formoterol is usually administered as a racemic (rac-) mixture of (R,R)- and (S,S)-enantiomers. While formoterol is restricted by the World Anti-Doping Agency (WADA), inhalation of formoterol is permitted to a predetermined dose (54 µg/24 hours) and a urine threshold of 40 ng/mL. However, chiral switch enantiopure (R,R)-formoterol is available, effectively doubling the therapeutic advantage for the same threshold. The aim of this study was to investigate whether formoterol exhibits enantioselective urinary pharmacokinetics following inhalation. Six healthy volunteers were administered a 12 µg inhaled dose of rac-formoterol. Urine was collected over 24 hours and analyzed by enantioselective ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay. Total (free drug plus conjugated metabolite) median (min-max) rac-formoterol urine levels following inhalation were 1.96 (1.05-13.4) ng/mL, 1.67 (0.16-9.67) ng/mL, 0.45 (0.16-1.51) ng/mL, 0.61 (0.33-0.78) ng/mL, and 0.17 (0.08-1.06) ng/mL at 2, 4, 8, 12, and 24 hours, respectively, well below the 2019 urine threshold. The proportion of conjugation differed between enantiomers with glucuronide conjugation much greater for (R,R)-formoterol (around 30%-60% of total) compared to (S,S)-formoterol (0%-30%). There was clear evidence of inter-individual enantioselectivity observed in the ratios of (R,R):(S,S)-formoterol, where (S,S)- was predominant in free formoterol, and (R,R)- predominant in the conjugated metabolite. In conclusion, rac-formoterol delivered by inhalation exhibits enantioselective elimination in urine following single-dose administration. Enantioselective assays should be employed in doping control to screen for banned beta2-agonist chiral switch products such as (R,R)-formoterol, and total hydrolyzed rac-formoterol is warranted to account for inter-individual differences in enantioselective glucuronidation.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/urina , Fumarato de Formoterol/urina , Glucuronídeos/urina , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Adulto , Cromatografia Líquida de Alta Pressão , Doping nos Esportes , Feminino , Fumarato de Formoterol/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estereoisomerismo , Detecção do Abuso de Substâncias/métodos , Espectrometria de Massas em Tandem , Adulto Jovem
13.
Drug Test Anal ; 11(7): 1048-1056, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30836453

RESUMO

While studies have demonstrated substantial differences in beta2 -adrenergic agonist enantiomer pharmacology, enantioselective disposition of long-acting beta2 -adrenergic ligand racemic (rac)-formoterol in blood is inadequately explored after inhaled therapy given analytical challenges. Furthermore, information on enantioselective disposition and partitioning of beta2 -adrenergic agonist in skeletal muscle is absent despite its promising data on muscle anabolism in humans. Using a sensitive ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS) assay, we determined disposition of (R,R)-formoterol and (S,S)-formoterol in plasma and skeletal muscle samples from 11 non-asthmatic men who had inhaled rac-formoterol at therapeutic doses (2 × 27 µg). Mean (SD) concentrations of (R,R)- and (S,S)-formoterol in plasma and in muscle biopsies of the vastus lateralis 1 hour after inhalation of formoterol were 31 (15) and 45 (18) pg × mL-1 for (R,R)-formoterol and (S,S)-formoterol, respectively, in plasma, and 0.56 (0.32) and 0.51 (0.29) pg × mgwet wt -1 , respectively, in muscle. Formoterol exhibited different enantioselective disposition in plasma and muscle (p < 0.0001). In plasma, mean log (R,R):(S,S)-formoterol ratio was lower than 0 [-0.17(0.07), p < 0.0001], whereas in muscle, mean log (R,R):(S,S)-formoterol ratio was slightly higher than 0 [0.04(0.07), p < 0.05]. Log (R,R):(S,S)-formoterol ratio in muscle was related to muscle fiber-type composition. Furthermore, formoterol induced an approximately two-fold increase in muscle p-PKASer/thr phosphorylation (p < 0.01), indicating a substantial beta2 -adrenergic response. Collectively, these findings suggest that formoterol exhibits modest enantioselective disposition in plasma after inhaled therapy in humans, which appear related to a greater (R,R)-enantiomer disposition in skeletal muscle that may be dependent on fiber-type composition.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/farmacocinética , Broncodilatadores/farmacocinética , Proteínas Quinases Dependentes de AMP Cíclico/metabolismo , Fumarato de Formoterol/farmacocinética , Músculo Esquelético/efeitos dos fármacos , Transdução de Sinais/efeitos dos fármacos , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/sangue , Agonistas de Receptores Adrenérgicos beta 2/farmacologia , Adulto , Broncodilatadores/administração & dosagem , Broncodilatadores/sangue , Broncodilatadores/farmacologia , Cromatografia Líquida de Alta Pressão/métodos , Fumarato de Formoterol/administração & dosagem , Fumarato de Formoterol/sangue , Fumarato de Formoterol/farmacologia , Humanos , Músculo Esquelético/metabolismo , Estereoisomerismo , Espectrometria de Massas em Tandem/métodos , Adulto Jovem
14.
Artigo em Inglês | MEDLINE | ID: mdl-30643398

RESUMO

Background: Formoterol fumarate inhalation solution (FFIS; Perforomist®) is a long-acting ß2-agonist (LABA) marketed in the US as a nebulized COPD maintenance treatment. Because long-term LABA use was associated with a potential increased risk of exacerbation or death in asthma patients, the US Food and Drug Administration (FDA) requested a postmarketing commitment study to evaluate long-term safety in COPD patients. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, noninferiority study. Patients (N=1,071; mean age, 62.6 years; 48.5% male; 89.7% white) with moderate-to-severe COPD on stable COPD therapy received FFIS (20 µg; n=541) or placebo (n=530) twice daily. The primary end point was the combined incidence of respiratory death, first COPD-related ER visit, or first COPD exacerbation-related hospitalization during 1 year post randomization. Noninferiority to placebo was concluded if the two-sided 90% CI of the HR of FFIS to placebo was <1.5. Secondary end points included spirometry. Results: The planned 1-year treatment period was completed by 520 patients; 551 discontinued prematurely (FFIS: 45.7%; placebo: 57.4%). The median treatment duration was approximately 10 and 7 months for FFIS and placebo, respectively. Among 1,071 randomized patients, 121 had ≥1 primary event (FFIS: 11.8%; placebo: 10.8%). The estimated HR of a primary event with FFIS vs placebo was 0.965 (90% CI: 0.711, 1.308), demonstrating that FFIS was noninferior to placebo. No respiratory deaths were observed in the FFIS group. Adverse events were similar for FFIS vs placebo (patients with ≥1 treatment-emergent adverse events: 374 [69.1%] vs 369 [69.6%], respectively). Compared with placebo, FFIS demonstrated statistically greater improvements from baseline in trough FEV1, FVC, percent predicted FEV1, and patient-reported outcomes (Transition Dyspnea Index). Conclusions: Nebulized FFIS was noninferior to placebo with respect to safety in patients with moderate-to-severe COPD. Additionally, fewer treatment withdrawals and larger lung function improvements were observed with FFIS compared with placebo when added to other maintenance COPD therapies.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Broncodilatadores/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Pulmão/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Idoso , Broncodilatadores/efeitos adversos , Progressão da Doença , Método Duplo-Cego , Esquema de Medicação , Feminino , Volume Expiratório Forçado , Fumarato de Formoterol/efeitos adversos , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Nebulizadores e Vaporizadores , Admissão do Paciente , Soluções Farmacêuticas , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Espirometria , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Capacidade Vital
15.
BMC Pulm Med ; 19(1): 22, 2019 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-30683080

RESUMO

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality all over the world. Acute exacerbation of COPD (AECOPD) not only accelerates the progression of disease, but also causes hospital administration and death events. Epidemiologic studies have shown air pollution is a high risk factor of AECOPD. However, there are rare technics or treatment strategies recommended to reduce severe air pollution related AECOPD. METHODS: This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. Seven hundred sixty-four stable COPD patients in group B, C and D according to GOLD 2017 will be recruited and equally divided into two parallel groups, salvational intervention (SI group) and control group (CT group). Original treatments for participants include tiotropium (18µg once q.d), budesonide/formoterol (160µg/4.5µg once or twice b.i.d) or budesonide/formoterol (160µg/4.5µg once or twice b.i.d) with tiotropium (18µg once q.d). The savational intervention for SI group is routine treatment plus budesonide/formoterol (160µg/4.5µg once b.i.d) from the first day after severe air pollution (air quality index, AQI ≥200) to the third day after AQI < 200. CT group will maintain the original treatment. The intervention will last for 2 years. Primary outcome is the frequency of AECOPD per year and the secondary outcomes include the incidence of unplanned outpatient visits, emergency visits, hospitalization, medical cost and mortality associated with AECOPD per year. DISCUSSION: The salvational intervention is a novel strategy for COPD management under severe air pollution. Results of the present study will provide reference information to guide clinical practice in reducing the air pollution related exacerbation of COPD. TRIAL REGISTRATION: This study has been registered at www.ClinicalTrials.gov (registration identifier: NCT03083067 ) in 17 March, 2017.


Assuntos
Poluição do Ar/efeitos adversos , Broncodilatadores/administração & dosagem , Progressão da Doença , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Pequim , Budesonida/administração & dosagem , Feminino , Fumarato de Formoterol/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Regressão , Brometo de Tiotrópio/administração & dosagem
16.
Telemed J E Health ; 25(3): 230-236, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30016216

RESUMO

BACKGROUND: Proper inhaler technique is important for effective drug delivery and symptom control in chronic obstructive pulmonary disease (COPD) and asthma, yet not all patients receive inhaler instructions. INTRODUCTION: Using a retrospective chart review of participants in a video telehealth inhaler training program, the study compared inhaler technique within and between monthly telehealth visits and reports associated with patient satisfaction. MATERIALS AND METHODS: Seventy-four (N = 74) rural patients prescribed ≥1 inhaler participated in three to four pharmacist telehealth inhaler training sessions using teach-to-goal (TTG) methodology. Within and between visit inhaler technique scores are compared, with descriptive statistics of pre- and postprogram survey results including program satisfaction and computer technical issues. Healthcare utilization is compared between pre- and post-training periods. RESULTS: Sixty-nine (93%) patients completed all three to four video telehealth inhaler training sessions. During the initial visit, patients demonstrated improvement in inhaler technique for metered dose inhalers (albuterol, budesonide/formoterol), dry powder inhalers (formoterol, mometasone, tiotropium), and soft mist inhalers (ipratropium/albuterol) (p < 0.01 for all). Improved inhaler technique was sustained at 2 months (p < 0.01). Ninety-four percent of participants were satisfied with the program. Although technical issues were common, occurring among 63% of attempted visits, most of these visits (87%) could be completed. There was no significant difference in emergency department visits and hospitalizations pre- and post-training. DISCUSSION: This study demonstrated high patient acceptance of video telehealth training and objective improvement in inhaler technique. CONCLUSIONS: Video telehealth inhaler training using the TTG methodology is a promising program that improved inhaler technique and access to inhaler teaching for rural patients with COPD or asthma.


Assuntos
Asma/tratamento farmacológico , Fumarato de Formoterol/administração & dosagem , Fumarato de Formoterol/uso terapêutico , Educação de Pacientes como Assunto/métodos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Telemedicina/métodos , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/administração & dosagem , Broncodilatadores/uso terapêutico , Inaladores de Pó Seco , Feminino , Humanos , Masculino , Inaladores Dosimetrados , Pessoa de Meia-Idade , Estudos Retrospectivos
17.
Expert Rev Respir Med ; 13(1): 5-11, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30463457

RESUMO

INTRODUCTION: The triple therapy term covers the combination of inhaled corticosteroid (ICS), long-acting ß-receptor agonist (LABA) and long-acting anticholinergic drug (LAMA) in one or in separate inhalers. The latest GOLD 2018 (Global Initiative for Chronic Obstructive Disease) guidelines recommend the triple therapy in the management of chronic obstructive pulmonary disease (COPD) in patients of group D who despite the combination of two drugs: LAMA/LABA or ICS/LABA continue to have persistent symptoms or suffer from further frequent exacerbations. Areas covered: The first triple fixed-dose combination of extrafine beclomethasone/formoterol/glycopyrronium in one pMDI type inhaler intended for the treatment of COPD has been registered in Europe in 2017. Pharmacokinetic and pharmacodynamic properties, clinical efficacy and safety of this triple combination are presented in the review. Expert commentary: A 20% reduction in the risk of moderate or severe exacerbation was found in patients receiving triple therapy compared to the ICS/LABA combination and LAMA monotherapy. Triple therapy reduces the number of exacerbations in comparison with double bronchodilatation (LABA/LAMA), thus representing an interesting therapeutic option in the management of COPD. The profile of side effects of triple therapy is typical for individual active agents included in the combination.


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Beclometasona/administração & dosagem , Antagonistas Colinérgicos/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Glucocorticoides/administração & dosagem , Glicopirrolato/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Broncodilatadores/uso terapêutico , Quimioterapia Combinada , Humanos , Nebulizadores e Vaporizadores , Doença Pulmonar Obstrutiva Crônica/fisiopatologia
18.
Pharm. care Esp ; 21(4): 221-229, 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-185115

RESUMO

Como parte del curso de Atención Farmacéutica II de la Licenciatura en Farmacia de la Universidad de Costa Rica los estudiantes, bajo la supervisión de profesores de la cátedra, ofertan el servicio de Seguimiento Farmacoterapéutico (SFT) a pacientes crónicos polimedicados que lo requieran. Se presenta un caso de una paciente femenina de 50 años con asma bronquial severa no controlada con polimedicación. Se le brinda el servicio de SFT, se identifican resultados negativos asociados a la medicación (RNM) manifestados y potenciales, se realizan intervenciones farmacéuticas que permiten un control del asma evaluado con Asthma Control Test (ACT) de 23 y un valor de pico flujo de 420L/ min luego de la intervención


The students of the Degree in Pharmacy from the University of Costa Rica took part in a course called Pharmaceutical Care II part. As a section of this course and under the supervision of their professors, the students offered a service of pharmacotherapeutic follow-up to polymedicated chronic patients who require it. A case of a 50 years old female patient was presented. She suffered uncontrolled severe bronchial asthma with polymedication. The pharmacotherapeutic follow-up service was given to the patient. Negative results associated to the medication were identified as manifested or potential. Thus, pharmaceutical interventions were performed and allowed to control a health problem as it was shown by an ACT punctuation of 23 and a peak flow value of 420 L/min after the intervention


Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Otimização , Asma/tratamento farmacológico , Cooperação do Paciente , Assistência Farmacêutica , Educação de Pacientes como Assunto , Beclometasona/administração & dosagem , Fumarato de Formoterol/administração & dosagem , Broncodilatadores/administração & dosagem , Ipratrópio/administração & dosagem , Albuterol/administração & dosagem , Índice de Gravidade de Doença , Polimedicação
20.
Int J Pharm ; 553(1-2): 47-56, 2018 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-30321640

RESUMO

The aerodynamic performance of a dry powder for inhalation depends on the formulation and the dry powder inhaler (DPI). In the case of capsule-based DPIs, the capsule also plays a role in the powder aerosolisation and the dispersion of the micronized drug during the inhalation. This study evaluated the impact of gelatine capsules (Quali-G™ and Hard Gelatine Capsules for DPIs), cold-gelled hypromellose (HPMC) capsules (Quali-V®-I and Vcaps®) and thermal-gelled HPMC capsules (Vcaps®Plus) from Qualicaps® and Capsugel® respectively, on the delivered dose (DD), fine particle dose (FPD), and capsule retention for formoterol-lactose binary and ternary blends. This study used a low resistance Axahaler® DPI based on the RS01 design (Plastiape, Italy). Similar trends were observed with the different capsule types that packaged both dry powder formulations. The highest DD and FPD and the lowest formoterol capsule retention were observed with cold-gelled HPMC capsules such as Quali-V-I® and Vcaps®, without significant differences between these capsules (p > 0.05, one-way ANOVA with Newman-Keuls post-hoc test) for both dry powders. Therefore, the capsule composition and manufacturing process have an influence on aerodynamic performance. In addition, the ternary blend showed higher DDs and FPDs but also higher capsule retention in comparison to the binary blend.


Assuntos
Broncodilatadores/administração & dosagem , Inaladores de Pó Seco , Fumarato de Formoterol/administração & dosagem , Lactose/química , Administração por Inalação , Aerossóis , Cápsulas , Química Farmacêutica/métodos , Excipientes/química , Gelatina , Derivados da Hipromelose/química , Tamanho da Partícula
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