Comparison of a portable, pneumotach flow-sensor-based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients-a randomized, crossover study.

BACKGROUND: Spirofy™ is India's first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices. METHODS: In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV1/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers. RESULTS: Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV1 values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV1 values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV1/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices. CONCLUSION: Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma. TRIAL REGISTRATION: CTRI/2021/09/036492 (Clinical Trials Registry - India).

Tackling Counterfeit Drugs: The Challenges and Possibilities.

Drugs that have been manufactured or packaged fraudulently are referred to as counterfeit/fake/spurious/falsified drugs because they either lack active ingredients or have the incorrect dosages. Counterfeiting of drugs has become a global issue with which the whole world is grappling. The World Health Organization states the frightening figure in which almost 10.5% of the medications worldwide are either subpar or fake. Although developing and low-income countries are the targets of the large-scale drug counterfeiting activities, fake/substandard drugs are also making their way into developed nations including the USA, Canada, and European countries. Counterfeiting of drugs is leading to not only economic loss but is also playing its part in the morbidity and mortality of patients. The recent COVID-19 pandemic fuelled the demand for certain categories of medicines such as antipyretics, remdesivir, corticosteroids, vaccines, etc., thus increasing the demand and manufacture of subpar/fake medicines. This review articulates the current trends and global impact of drug counterfeiting, current and potential measures for its prevention and the role of different stakeholders in tackling the menace of drug counterfeiting.

Breath-actuated INhalation TheRapy: survey of phySicians' PErCepTion (INTROSPECT) in Nepal.

OBJECTIVE: Breath-actuated inhalers (BAIs) are gaining attention in the management of obstructive airway diseases (OADs). In Nepal, a BAI containing fluticasone propionate/salmeterol (FPS) has been available for a year. This survey is aimed at determining the perception and experience of physicians in Nepal concerning BAIs. METHODS: A cross-sectional, questionnaire-based survey was conducted. A total of 141 physicians participated and filled the survey. RESULTS: Most physicians felt that the right device should be easy to teach, learn and remember. They considered coordination and multiple steps as the primary challenges with pressurized metered-dose inhalers and dry powder inhalers, respectively. Most of them agreed that BAIs could address these challenges. BAIs were not only preferred by most of the physicians for asthma and chronic obstructive pulmonary disease but were also the preferred choice in newly diagnosed patients. Physicians believed that if current patients were shifted to BAIs, it could improve inhalation technique (88%) and compliance/adherence (81%). Almost all of them (92-97%) agreed that teaching the breathing technique and the cleaning process was easier and faster in BAIs. BAIs were considered easy and simple to use. Also, BAI's dose-counter helps patients to increase adherence to inhalation therapy. CONCLUSIONS: In this INTROSPECT survey, physicians in Nepal believed that BAIs could address the key challenges faced with using pMDIs and DPIs in asthma and COPD patients.

A narrative review on the Synchrobreathe™: A novel breath-actuated pressurised metered-dose inhaler for the treatment of obstructive airway diseases.

Pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), are widely used to deliver drugs for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Incorrect use of inhalers is one of the main obstacles to achieving better clinical control. Indeed, with pMDIs, patients fail to synchronise actuation with inhalation due to a lack of coordination and with DPIs insufficient inspiratory effort compromises drug deposition in lungs. More than 50% of patients desire to switch their pMDIs and DPIs for a better device. This led to the development of pressurised breath-actuated inhalers (BAIs) with the aim of combining the beneficial features of pMDIs and DPIs and mitigating their problems. BAIs, e.g., Synchrobreathe™, are designed such that they are activated by a low inhalation effort and mechanically actuate the dose in synchrony to inspiration, thereby resolving the need to coordinate actuation with inspiration. BAIs have advantages, including ease of use, high lung deposition of medication, and greater patient preference. We discussed the design features, operating procedure, and clinical evidence of the Synchrobreathe™ device (Cipla Ltd, India), a BAI available with a wide range of drug combinations. Studies have shown that a higher number of patients (68.19%) used the Synchrobreathe™ without any error than the pMDI (56.21%), and that the vast majority of them (92%) found it easy to understand and use. The Synchrobreathe™ is an innovative, easy-to-use inhaler that may overcome many limitations associated with pMDIs and DPIs, thus potentially improving management of obstructive airway diseases and patients' quality of life.

Perceptions and Attitudes of Patients and Their Family Caregivers on Nebulization Therapy for COPD.

Purpose: The aim of the survey was to evaluate attitudes and perceptions toward nebulization therapy for the management of chronic obstructive pulmonary disease (COPD) in Indian population. Patients and methods: A cross-sectional, multicenter, quantitative survey was conducted from July to August 2019 among 103 COPD patients [>40 years, either gender, belonging to socio-economic class (SEC) A or SEC B] and their family caregivers. One-on-one interviews were conducted telephonically via an online survey platform (KoBo data collection tool) using a structured questionnaire. Patients receiving home nebulization were included, and the usage of nebulizers, satisfaction, and benefits and concerns with nebulizers were assessed. Results: Overall, 47% patients were on handheld inhalers + nebulizer, 54% used nebulizer for >8 weeks, and 27% used nebulizers daily for home maintenance. Majority of the patients (77%) were satisfied with nebulization therapy. Around 70% family caregivers opined that the quality of life of COPD patients improved post-nebulization therapy. The benefits of nebulizers perceived by patients were easier breathing (89%), feeling of well-being (86%), and ease of use (86%), while family caregivers reported reduced hospitalization (76%) and easier breathing (75%). Among those with prior experience with inhalers, 72% felt nebulizers gave long-term relief, while 65% perceived having immediate relief compared to inhaler. Overall, 61% opined that benefits with nebulizers outweighed the inconvenience associated with its use. Key concerns regarding nebulizers cited by patients were time-consuming procedure (50%), feeling of dependency (49%), and social embarrassment (48%), while family caregivers highlighted social embarrassment (45%) and multiple daily use (45%) as major concerns. Majority of the patients (73%) were compliant with their recommended frequency of the nebulizer. Conclusion: This first-of-its-kind survey highlights that the majority of patients and family caregivers were satisfied with nebulizers and reported improvements in symptoms and reduced hospitalizations with nebulizer therapy. The patients preferred nebulized therapy to inhalers.

A review of the efficacy and safety of fluticasone propionate/formoterol fixed-dose combination.

INTRODUCTION: Fluticasone propionate/formoterol fumarate (FP/FORM) is one of the newer combinations among inhaled corticosteroid (ICS) and long-acting ß2-agonist (LABA) combination formulations currently available. To evaluate the efficacy and safety of this FP/FORM combination, it is important to review all the available evidence and take a comprehensive look at the current and relevant data in the patient population suffering from asthma and chronic obstructive pulmonary disease (COPD). AREAS COVERED: In this focused review, we summarize the available literature published until January 2021 using the PubMed/Medline and Cochrane Controlled Trials Register databases on the efficacy and safety of FP/FORM with its mono-components; concurrent administration of FP+FORM; and with other ICS/LABA combinations in asthma and COPD patients. EXPERT OPINION: FP/FORM combination therapy is a strong alternative in the treatment of persistent asthma and moderate-severe COPD. Extensive study of several trials has established the superior efficacy of FP/FORM combination therapy over FP or FORM monotherapy, comparable efficacy with FP+FORM and non-inferiority to other ICS/LABA fixed-dose combinations. The safety profile of FP/FORM has also been found to be comparable with respect to its mono-components and their concurrent use, and also other ICS/LABA combinations such as formoterol/budesonide and fluticasone/salmeterol.

Safety and clinical outcomes of remdesivir in hospitalised COVID-19 patients: a retrospective analysis of active surveillance database.

BACKGROUND: Real-world data on safety and clinical outcomes of remdesivir in COVID-19 management is scant. We present findings of data analysis conducted for assessing the safety and clinical outcomes of remdesivir treatment for COVID-19 in India. METHODS: This retrospective analysis used data from an active surveillance programme database of hospitalised patients with COVID-19 who were receiving remdesivir. RESULTS: Of the 2329 patients included, 67.40% were men. Diabetes (29.69%) and hypertension (20.33%) were the most common comorbidities. At remdesivir initiation, 2272 (97.55%) patients were receiving oxygen therapy. Remdesivir was administered for 5 days in 65.38% of patients. Antibiotics (64.90%) and steroids (47.90%) were the most common concomitant medications. Remdesivir was overall well tolerated, and total 119 adverse events were reported; most common were nausea and vomiting in 45.40% and increased liver enzymes in 14.28% patients. 84% of patients were cured/improved, 6.77% died and 9.16% showed no improvement in their clinical status at data collection. Subgroup analyses showed that the mortality rate was significantly lower in patients < 60 years old than in those > 60 years old. Amongst patients on oxygen therapy, the cure/improvement rate was significantly higher in those receiving standard low-flow oxygen than in those receiving mechanical ventilation, non-invasive ventilation, or high-flow oxygen. Factors that were associated with higher mortality were age > 60 years, cardiac disease, diabetes high flow oxygen, non-invasive ventilation and mechanical ventilation. CONCLUSION: Our analysis showed that remdesivir is well tolerated and has an acceptable safety profile. The clinical outcome of cure/improvement was 84%, with a higher improvement in patients < 60 years old and on standard low-flow oxygen.

Efficacy and safety of glycopyrronium/formoterol delivered via a dry powder inhaler in patients with moderate to severe chronic obstructive pulmonary disease: Results from a multi-centre, open-label, randomised study.

Background: We designed this randomised, open-label, parallel group, multi-centre study to investigate the efficacy and safety of glycopyrronium/formoterol, a long-acting muscarinic antagonist/long-acting ß2-agonist fixed dose combination, delivered through a dry powder inhaler (DPI) in patients with chronic obstructive pulmonary disease (COPD). Material and Methods: We randomised (1:1) patients with moderate to severe COPD (N = 356) to receive glycopyrronium 25 µg/formoterol 12 µg via DPI twice daily (GF-DPI) or glycopyrronium 50 µg monotherapy via DPI once daily (G-DPI). The primary study endpoint was the mean change from the baseline in pre-dose trough-forced expiratory volume in one second (FEV1) at 12 weeks. Results: At week 12, the mean increase from the baseline in pre-dose trough FEV1 was higher in the GF-DPI group (120 ml) than in the G-DPI (60 ml) group. The mean difference (MD) between treatment groups was 0.06 L (95% CI: 0.00-0.12 L, P < 0.0001 for non-inferiority). At week 12, the mean pre-dose forced vital capacity (FVC), 1 hour post-dose FEV1, and post-dose FVC increased significantly from the baseline only in the GF-DPI group (p < 0.0001). The reduction in the COPD assessment test score was greater in the GF-DPI group (p = 0.0379). The average daily number of puffs of rescue medication and the reduction in mean modified Medical Research Council scale, COPD, and Asthma Sleep Impact Scale score at week 12 were similar between groups (p > 0.05). Overall, 35 adverse events and two serious adverse events unrelated to study drugs were reported. Both groups had similar results for overall drug safety. Conclusion: The results demonstrate efficacy and safety of GF-DPI in Indian patients with moderate to severe COPD. Treatment with GF-DPI significantly improved the lung function and quality of life and was well tolerated.

The emerging role of mycophenolate mofetil in interstitial lung diseases.

INTRODUCTION: Mycophenolate mofetil (MMF), initially approved to prevent rejection in solid organ allograft, is now being increasingly used for other conditions. Over the last decade, MMF has emerged as a useful therapy for a variety of immune-mediated diseases. AREAS COVERED: There has been a growing interest in the clinical use of MMF in the treatment of ILDs due to its versatile anti-inflammatory, immunomodulatory, anti-fibrotic and anti-proliferative properties. In this focussed review, we summarize the available literature using the Pubmed, Science Direct and EMBASE databases published until June 2021 on the efficacy and tolerability of MMF in various ILDs. EXPERT OPINION: Other than idiopathic pulmonary fibrosis (IPF) and its broader category of progressive fibrosing ILD, there have been no drugs approved by relevant regulatory agencies for the treatment of the multiple other forms of ILD. Though results are limited, immunosuppressants such as MMF have shown promise as an effective and well-tolerated steroid-sparing agent, providing hope that the limited treatment armamentarium for ILDs can be expanded.

Understanding Practice Patterns of COPD: A Survey of Physicians in Nepal, Sri Lanka and Malaysia.

INTRODUCTION: There is much recent data from Nepal, Sri Lanka and Malaysia that can help us understand the practice patterns of physicians regarding the diagnosis and management of chronic obstructive pulmonary disease (COPD) in these countries. We conducted this survey to understand the practice patterns of physicians related to the diagnosis and management of COPD in these three countries. METHODS: This questionnaire-based, observational, multicentre, cross-sectional survey was carried out with 438 randomly selected physicians consulting COPD patients. RESULTS: In the survey, 73.29% of the physicians consulted at least five COPD patients daily (all patients > 40 years of age). 31.14% of the COPD patients visiting their doctors were women. Among physicians, 95.12% reported that at least 70% of their patients were smokers. 34.18% of the physicians did not routinely use spirometry to diagnose COPD. Most physicians preferred a short-acting ß2-agonist (SABA) (28.19%) in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group-A and long-acting muscarinic receptor antagonist plus long-acting ß2-agonist/inhaled corticosteroids (LAMA + LABA/ICS) in both the GOLD Group-C (39.86%) and Group-D (72.89%) patients. A significant number (40.67%) of physicians preferred LABA/LAMA for their GOLD Group-B patients. A pressurised metered dose inhaler (pMDI) with or without spacer was the most preferred device. Only 23.67% of the physicians believed that at least 70% of their patients had good adherence (> 80%) to therapy. Up to 54.42% of the physicians prescribed inhalation therapy to every COPD patient. Also, 39.95% of the physicians evaluated their patients' inhalation technique on every visit. Up to 52.67% of the physicians advised home nebulisation to > 10% of patients, with nebulised SABA/short-acting muscarinic receptor antagonist (SAMA) being the most preferred management choice. Most physicians offered smoking cessation advice (94.16%) and/or vaccinations (74.30%) as non-pharmacological management, whereas pulmonary rehabilitation was offered by a smaller number of physicians. Cost of therapy and poor technique were the most common reasons for non-adherence to COPD management therapy. CONCLUSION: Awareness of spirometry can be increased to improve the diagnosis of COPD. Though physicians are following the GOLD strategy recommendations for the pharmacological and non-pharmacological management of COPD, awareness of spirometry could be increased to improve proper diagnosis. Regular device demonstration during each visit can improve the inhalation technique and can possibly increase adherence to treatment.

The emerging role of nebulization for maintenance treatment of chronic obstructive pulmonary disease at home.

Inhalation therapy is the cornerstone of chronic obstructive pulmonary disease (COPD) management. However, for many COPD patients who are managed at home, nebulization therapy offers an effective alternative treatment and fulfills the gap of catering to the specific population of patients who are unable to use handheld inhaler devices appropriately. The present review highlights key aspects, namely selection of the right beneficiaries for home nebulization, available drugs in nebulized formulations for the treatment of COPD, and the importance of care, cleaning, and maintenance, which are prerequisites for ensuring successful nebulization therapy.

The evidence for using tenofovir disoproxil fumarate plus lamivudine as a nucleoside analogue backbone for the treatment of HIV.

This article evaluates the evidence supporting use of the tenofovir disoproxil fumarate (TDF) plus lamivudine (3 â€‹TC) combination as a dual nucleoside backbone within a triple drug antiretroviral regimen. Key trials that assess the relative efficacy, safety and resistance profile of 3 â€‹TC and emtricitabine (FTC) are discussed. Clinical use of 3 â€‹TC and FTC with two tenofovir prodrugs -TDF and tenofovir alafenamide (TAF) - is presented. Recommendations from various international guidelines for the construction of triple and emerging dual regimens are summarised. In conclusion, data suggest the therapeutic equivalence of 3 â€‹TC and FTC, especially when 3 â€‹TC is combined with TDF.

Knowledge, practice pattern and attitude toward asthma management amongst physicians from Nepal, Malaysia, Lebanon, Myanmar and Morocco.

OBJECTIVE: This survey aimed to understand the physicians' practice pattern and challenges faced while treating their patients with asthma in five countries-Malaysia, Nepal, Myanmar, Morocco and Lebanon. METHODS: Questionnaire-based data was gathered from internal medicine doctors (209), general practitioners (206), chest physicians (152) and pediatricians (58) from 232 locations from across the five countries. RESULTS: Of the 816 physicians, 374 physicians encountered at least 5 asthma patients daily. Approximately, 38% physicians always used spirometry for diagnosis and only 12% physicians always recommended Peak flow meter (PFM) for home-monitoring. Salmeterol/fluticasone (71%) followed by formoterol/budesonide (38%) were the most preferred ICS/long-acting beta2-agonists (LABA); Salbutamol (78%) was the most preferred reliever medication. 60% physicians said >40% of their patients were apprehensive to use inhalers. 72% physicians preferred a pressurized metered-dose inhaler (pMDI) to a dry powder inhaler (DPI) with only a third of them using a spacer with the pMDI. 71% physicians believed that using similar device for controller and reliever can be beneficial to patients. Skipping medicines in absence of symptoms (64%), incorrect inhaler technique (48%) and high cost of medication (49%) were considered as major reasons for non-adherence by most physicians. Incorrect inhaler technique (66%) and nonadherence (59%) were considered the most common causes of poor asthma control. CONCLUSIONS: There are opportunities to improve the use of diagnostic and monitoring tools for asthma. Non-adherence, incorrect inhaler technique and cost remain a challenge to achieve good asthma control. Asthma education, including correct demonstration of inhaler, can potentially help to improve inhaler adherence.

Comparing the efficacy and safety of formoterol/budesonide pMDI versus its mono-components and other LABA/ICS in patients with asthma.

INTRODUCTION: Pressurised metered dose inhalers (pMDIs) are effective drug delivery devices prescribed in obstructive airway diseases due to their convenience, portability, ease of enabling multiple doses in a single formulation, and storage in any orientation. For the management of asthma, the fixed-dose combination of a long-acting ß2-agonist (LABA) and an inhaled corticosteroid (ICS) has been recommended by Global Initiative for Asthma guideline as a preferred treatment option for patients who are uncontrolled with only ICS doses. One of the available LABA/ICS combinations is the formoterol/budesonide (FB). AREAS COVERED: This article systematically reviews the efficacy and safety of the FB pMDI compared with the FB dry powder inhaler (DPI), individual mono-components (formoterol and budesonide) or salmeterol/fluticasone (SF) combination in the treatment of asthma among paediatric and adult patients. PubMed was searched with the string: ''((Budesonide) AND Formoterol) AND ((((pMDI) OR MDI) OR Pressurised Metered-dose inhaler) OR Metered-dose inhaler)'', in ALL fields. Screening of all the articles was done till February 2020. We have included 24 articles from the total of 142 hits received. CONCLUSIONS: The FB pMDI is efficacious for the long-term management of asthma in patients 6 years of age and above. It has been shown to improve lung function and asthma control, and to reduce daytime and night-time symptoms, the number of rescue medication doses and asthma exacerbations. It also showed rapid onset of bronchodilatory effect with a dose-response relationship that allows patients to utilise it as a Single Maintenance And Reliever Therapy (SMART) regimen.

Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.

BACKGROUND: The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD. PATIENTS AND METHODS: In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV1) at week 24. Pre and post-dose (30 min) FEV1, Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients. RESULTS: Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV1 (% predicted) 39 ± 16%], 253 completed the study. Mean change in pre-dose FEV1 from baseline to week 24 increased significantly after administering the triple drug combination [580 ± 600 mL, 95% CI (510, 650 mL), p < 0.0001]. The increase in the pre-dose FEV1 was significant at all time points (p < 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV1 and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV1 both among smokers [mean change 200 ± 430 mL, 95% CI (130, 270 mL), p < 0.0001] as well as non-smokers [990 ± 470 mL, 95% CI (900, 1070 mL), p < 0.0001] at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV1 and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: -6.6 ± 6.07; smokers: -5.17 + 6.96; non-smokers: 8.06 ± 4.44; all p < 0.0001). The mean difference between the two groups was 2.88 (p < 0.0001) at week 24. TFC was well tolerated. CONCLUSION: In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.

Device-handling study of a novel breath-actuated inhaler, Synchrobreathe®, versus a pMDI.

INTRODUCTION: Synchrobreathe®, a new-generation, novel breath-actuated inhaler (BAI) can address the key issues arising during the use of both pressurised metered dose inhalers ([pMDIs]; hand-breath coordination) and dry powder inhalers ([DPIs]; high inspiratory flow required) with respect to optimal drug deposition. MATERIALS AND METHODS: This was an open-label, prospective, 2-week, multicentre study that assessed device handling, ease of use, errors and participant perception regarding the use of Synchrobreathe® versus a pMDI in patients with chronic obstructive pulmonary disease (COPD) (n = 162) or asthma (n = 239) and inhaler-naïve healthy volunteers (n = 59). Ability to use the device without errors at the first attempt, total number of errors before and after training, time taken to use the device correctly and total number of training sessions, and number of attempts to perform the correct technique on Day 1 and Day 14 were evaluated. Device handling and preference questionnaires were also administered on Day 14. RESULTS: Of 460 participants, 421 completed the study. The number of participants using Synchrobreathe without any error after reading the patient information leaflet (PIL) was significantly low (p < 0.05) on Day 1. On Day 14, significantly more number of participants used Synchrobreathe without any error (p < 0.001). The total number of errors before and after training with Synchrobreathe was significantly less (p < 0.001). The average time required to perform the inhalation technique correctly (p < 0.01) and the total number of attempts (P < 0.001) with Synchrobreathe were significantly lower. The average number of attempts to inhale correctly was significantly (p < 0.001) less with Synchrobreathe on Day1 and Day 14. Most participants rated Synchrobreathe as their choice of inhaler. CONCLUSION: Synchrobreathe is an easy-to-use and easy-to-handle device with significantly less number of errors, which may have positive implications for disease control in asthma and COPD.

Management of aging skin: A questionnaire-based study among Indian dermatologists.

INTRODUCTION: With increased life expectancy, the desire to look younger has increased. Hence, many patients approach dermatologists for antiaging treatment. However, data regarding management of skin aging in India are scarce. AIMS: To understand management patterns for skin aging among dermatologists in India. METHODS: Overall, 147 Indian dermatologists were administered a questionnaire-based survey about patient characteristics, signs of skin aging, treatment options, and cost. RESULTS: Among all the patients coming for dermatologists' consultation, 10%-40% were for antiaging treatment. About 70% dermatologists opined that majority of patients aged 30-40 years consulted for antiaging treatment, and the male to female ratio was 3:7. Approximately 46% of dermatologists felt that antiaging treatment should be initiated by the age of 30. Common signs of aging were wrinkles, pigmentation, dull skin or complexion, and dry skin. Based on patient's age and sex, dermatologists prescribed a combination of 2-4 products, which included antioxidants, retinoids, growth factors, and moisturizers. Improvement was assessed by photographic and clinical evaluation, and by patients' satisfaction (55%). Effect of the antiaging products was evident within 4-6 months. Earliest improvement was noted in dry skin and dull complexion. Average extent of improvement noted by 6 months was approximately 20%-30%. The average monthly expenditure on antiaging treatments was 2000-4000 INR. CONCLUSION: Both men and women seek clinical treatment for skin aging in India. Dermatologists prescribe a combination of 2-4 products, including antioxidants, retinoids, growth factors, and moisturizers. Available antiaging therapies show an average improvement of up to 30% by 6 months.

Real-world evaluation of the clinical safety and efficacy of fluticasone/formoterol FDC via the Revolizer® in patients with persistent asthma in India.

The combination of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABAs) is widely used for the management of asthma. This prospective, open-label, non-comparative, observational, 24-week multicentre study is the first real-world study from India to compare the efficacy and safety of fixed-dose combination of fluticasone/formoterol (Maxiflo® 100/6 mcg or 250/6 mcg) capsules via the Revolizer® device in patients with persistent asthma. The primary efficacy analyses included mean change in Asthma Control Test (ACT™) at 4, 8, 16 and 24 weeks. Secondary efficacy analyses included mean change in morning and evening peak expiratory flow rate (PEFR) at the end of 4, 8, 16 and 24 weeks, number of patients having symptom-free days and nights at the end of 4, 8, 16 and 24 weeks, the number and severity of exacerbations over 24 weeks and response to the Usability Preference Satisfaction Confidence questionnaire after 1 week. Overall, 385 (of 401; 96.01%) enrolled patients completed the study. The mean change in ACT™ score was 6.7 ± 3.71 (95% CI: 6.32, 7.06; p < 0.0001) at week 24. The ACT™ score at weeks 4, 8 and 16 showed progressive and statistically significant increase from baseline. A statistically significant improvement in morning and evening PEFR at weeks 4, 8, 16 and 24 was reported. The proportion of patients experiencing symptom-free days and nights continuously increased from baseline to week 24. A good safety profile over the 24-week period was observed. The Revolizer® device was preferred by 94.26% patients over their current device. Fluticasone propionate/formoterol fumarate FDC capsules administered via a single-dose dry powder inhaler ([DPI], (Revolizer®) offers a novel, well-tolerated and effective treatment option for the long-term management of asthma.

Coexistence of allergic rhinitis and asthma in Indian patients: The CARAS survey.

CONTEXT: Asthma patients often suffer from concomitant allergic rhinitis (AR). However, there is paucity of such data from India. AIMS: This questionnaire-based survey evaluated the coexistence of AR in Indian asthmatics, and examined the inter-relationship between the two disease conditions. SUBJECTS AND METHODS: This survey conducted in ten cities across India, aimed to generate information on exposure to risk factors, history of atopy, the severity of asthma, and treatment regimen in patients with physician-diagnosed asthma. RESULTS: Data were obtained from 1161 asthma patients (mean age [±standard deviation]: 40.41 [±17.05] years). Prevalence of coexisting AR was found to be 65.24%, with the highest prevalence (80%) in the southern regions of India. Sneezing (71.78%) followed by watery, runny nose (63.59%) were the most common AR symptoms. Majority (72.32%) of the patients had seasonal AR. Coexistence of AR and asthma was significantly associated with the presence of personal and family history of atopy (odds ratio 2.53 and 1.51 respectively; both P < 0.005). Passive smoking, exposure to biomass fuel, and the presence of pets and animals at home were also significantly (P < 0.005) associated with AR-asthma coexistence. Prevalence of AR was found to increase with increasing asthma severity. The usage of oral steroids was significantly higher in patients with coexistent AR-asthma. Sixty-six percent of the patients with coexistent AR-asthma were prescribed intranasal corticosteroids. CONCLUSIONS: The results of the Coexistence of Allergic Rhinitis and ASthma (CARAS) survey highlight the high prevalence of concomitant AR in Indian patients with asthma, and reinforce the need for early diagnosis and guideline-based management of AR in patients with asthma.

Preference of diagnostic tools, medications, and devices for asthma management: A survey of doctors in Algeria.

AIM: This study aimed to evaluate the doctors' perspectives in using tools for diagnosis, prescribing medications, and devices for the treatment of asthma in Algeria. METHODS: Data were collected from randomly selected physicians, pediatricians, allergists, and pulmonologists through a questionnaire-based survey in 12 cities and 60 rural locations across Algeria. RESULTS: Of the 213 doctors who responded to the survey, >90% doctors attended an average of 20 asthma patients daily. Peak flow meter was used by 69% doctors for diagnosis and by 93% for monitoring of asthma. Spirometer was used by 76% doctors for diagnosis of asthma. Budesonide (86%), fluticasone (46%), and beclomethasone (40%) were the most prescribed inhaled corticosteroid (ICS) by doctors. Formoterol/budesonide was the most preferred ICS/long-acting ß2-agonist (LABA) (72%), followed by salmeterol/fluticasone (57%) for asthma treatment. Salbutamol was preferred by 93% doctors as reliever medication. ICS was the preferred controller in mild asthma (76%), and ICS/LABA combination in moderate (74%) and severe asthma (80%). Most doctors (94%) preferred pressurized metered-dose inhalers (pMDIs) with (46%) or without spacer (48%) for their asthma patients. About 83% doctors believed that pMDI with spacer would show a better outcome in asthma, over pMDI alone. Continuous exposure to allergens/smoking (73%) and incorrect inhaler technique (66%) were the most common reasons for uncontrolled asthma. CONCLUSION: The use of diagnostic tools in asthma was found to be adequate among the doctors in Algeria. Most of the doctors managed asthma in accordance with the global initiative for asthma guidelines. Spacers were found to be less prescribed in regular treatment, despite having good awareness about its better outcomes.