A new approach to studying the nasal and oral breathing routes.

INTRODUCTION: Nasal obstruction is often reported by patients. It is a consequence of a subjective feeling of impaired airflow through the nasal cavity. Currently, objective measures of nasal patency rates are very limited. Functional tests only analyze nasal breathing; they do not simultaneously assess airflow through the mouth. OBJECTIVE: The aim of this study is to present a new functional test that assesses a single-stage nasal and oral breathing route. METHODS: The NOFA (Nasal-Oral Flow Analyzer) is a three-channel flow meter used to perform continuous and simultaneous measurements of nasal and oral respiratory parameters. We present the application of the device and the proposed study protocol. RESULTS: The respiratory tracks of four selected patients are presented. Different breathing patterns are visible: exclusive nasal, exclusive oral, and mixed nasal-oral ventilation pattern. CONCLUSIONS: The preliminary results suggest the potential use of the NOFA in ENT practice. Further studies are necessary to evaluate the usefulness of this device in the diagnosis of patients with upper respiratory tract disorders.

Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study.

BACKGROUND: Uncomplicated acute rhinosinusitis (ARS) is usually a self-limiting inflammatory condition often treated with antibiotics. AIMS: To assess the safety and efficacy of fluticasone furoate nasal spray (FFNS) compared with placebo for symptomatic relief of uncomplicated ARS. METHODS: A randomised, double-blind, placebo-controlled, parallel-group, multicentre, 2-week treatment study of FFNS 110 µg once and twice daily was undertaken in adults/adolescents. RESULTS: A statistically significant reduction was seen in the daily major symptoms score, a composite score of three individual symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip on a 0-3 scale) by both FFNS doses compared with placebo (least square mean differences vs. placebo of -0.386 (p=0.008) and -0.357 (p=0.014) for once daily and twice daily FFNS, respectively). The differences in median times to symptom improvement were not statistically significant between each dose of FFNS (7 days) and placebo (8 days). There were no treatment differences in antibiotic use for possible fulminant bacterial rhinosinusitis (3% in each group). The safety profile of FFNS was similar to placebo. CONCLUSIONS: FFNS reduces symptoms of uncomplicated ARS compared with placebo and is well tolerated, providing support for withholding antibiotics in selected patients.

[Laryngopharyngeal Reflux (LPR) in patients with persistent hoarseness]. / Refluks krtaniowo-gardlowy (LPR) u pacjentów z przewlekla chrypka

INTRODUCTION: In 2006 The Global Consensus Group in Montreal pointed out that chronic laryngitis is highly associated with gastroesophageal reflux disease (GERD). AIM OF THE STUDY: To evaluate the frequency of LPR in a selected group of patients with chronic hoarseness. We were also interested in assessment of the relationship between Reflux Symptoms Index (RSI) scores, Ryan scores from the pharyngeal pH monitoring and the morphological changes in the larynx according to Reflux Findings Score (RFS). In addition, we wanted to assess the frequency of various clinical symptoms included in the RSI questionnaire among patients with LPR. MATERIALS AND METHODS: 42 patients from an outpatient ENT clinic with chronic hoarseness and RSI ≥ 13. All subjects underwent pharyngeal pH monitoring with the Dx-pH System Restech ™ and laryngoscopy. RESULTS: Among 42 patients with chronic hoarseness, LPR was confirmed in 35 patients (83.33%). In 7 subjects pharyngeal pH monitoring was normal. Among all patients with confirmed LPR, only 5 out of 8 elements of RFS laryngoscopic changes were observed. The most frequent inflammatory changes noticed included erythema of the arytenoids and interarytenoid regions (posterior laryngitis). These findings were found in 30 out of 35 patients with LPR. Median value of RFS in patients with LPR was 4.45, which is lower than the cut off value of 7 necessary for recognition of LPR. There is statistically significant positive correlation between Ryan scores and the RFS scale results (correlation coefficient 0.91, p<0.001). CONCLUSIONS: Pharyngeal pH monitoring confirmed LPR in 83.33% selected group of patients with chronic hoarseness and RSI ≥ 13. Isolated erythema of arytenoid and interarytenoid region was the most frequent inflammatory abnormality found in the larynx. RFS values below 7 do not exclude the diagnosis of LPR. We can use RFS scales as a prognostic test of severity of LPR - due to statistically significant positive correlation between Ryan score and RFS values. The use of RSI scale revealed that the most frequent symptom among patient with LPR was throat clearing followed by hoarseness.

Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study.

BACKGROUND: The inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) and the long-acting ß2-agonist (LABA) formoterol fumarate (formoterol) are being made available as a combination product (fluticasone/formoterol, flutiform ®) in a single aerosol inhaler. This 12-week, open-label, randomized, active-controlled, parallel-group, multicentre, phase 3 study compared the efficacy and safety of fluticasone/formoterol with the commercially available combination product fluticasone/salmeterol. METHODS: Patients aged ≥ 18 years (N = 202) with mild-to-moderate-severe, persistent asthma for ≥ 6 months prior to screening were included in the study. After a screening phase (4-10 days), eligible patients were randomized 1:1 to receive fluticasone/formoterol or fluticasone/salmeterol during the 12-week treatment period. The primary objective was to demonstrate non-inferiority of fluticasone/formoterol versus fluticasone/salmeterol, measured by pre-dose forced expiratory volume in the first second (FEV1), at week 12. RESULTS: Fluticasone/formoterol was comparable to fluticasone/salmeterol for the primary efficacy endpoint, mean pre-dose FEV1 at week 12. The new combination was also comparable to fluticasone/salmeterol for change from baseline to week 12 in pre-dose FEV1, change from pre-dose FEV1 at baseline to 2-hour post-dose FEV1 at week 12 and discontinuations due to lack of efficacy. Importantly, fluticasone/formoterol was superior to fluticasone/salmeterol in time to onset of action throughout the duration of the study. The two treatments demonstrated similar results for various other secondary efficacy parameters, including other lung function tests, patient-reported outcomes, rescue medication use, asthma exacerbations and Asthma Quality of Life Questionnaire scores. Fluticasone/formoterol was well tolerated and had a good safety profile that was similar to fluticasone/salmeterol. CONCLUSIONS: The results of this study indicate that fluticasone/formoterol is as effective as fluticasone/salmeterol, and has a more rapid onset of action, reflecting the faster bronchodilatory effects of formoterol compared with those of salmeterol. If patients perceive the benefits of therapy with fluticasone/formoterol more rapidly than with fluticasone/salmeterol, this could have a positive impact on preference and adherence.

Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.

BACKGROUND: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol). METHODS: Patients aged ≥ 18 years (n=620) with a history of severe, persistent reversible asthma for ≥ 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period. RESULTS: Fluticasone/formoterol (500/20 µg, b.i.d.) was at least as effective as fluticasone + formoterol (500 µg + 24 µg, b.i.d.) with respect to the primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) in these two groups. Fluticasone/formoterol (500/20 µg, b.i.d.) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1) from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 µg, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 µg, b.i.d.) and fluticasone/formoterol (100/10 µg, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol. CONCLUSION: This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 µg, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters.

Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma.

OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations. METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups. RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01). CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.