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).

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.

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.

Small Airways, Big Problem: Extrafine beclomethasone/formoterol in asthma and chronic obstructive pulmonary disease.

Asthma and chronic obstructive pulmonary disease (COPD) are common chronic respiratory diseases characterized by an inflammatory process that extends from the central to peripheral airways. Conventional pressurized metered-dose inhalers and most dry-powder inhalers emit drug particles too large to target the small airways effectively. Advancements in drug formulation have given rise to a new generation of inhalers that can generate aerosols with extrafine drug particles that leads to more effective aerosol penetration into the lung periphery. An extrafine formulation of inhaled beclomethasone/formoterol (BDP-FF) with enhanced lung deposition is now available. This document reviews the various real-world and controlled studies that have evaluated the efficacy of extrafine BDP-FF in asthma and COPD.

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.

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.

Lipid management in India: a nationwide, cross-sectional physician survey.

BACKGROUND: Current international guidelines on dyslipidemia are not concordant on various aspects of management. Also, there are no uniformly accepted Indian guidelines. We, therefore, performed a physician survey to understand lipid management practices in India. METHODS: An anonymous survey questionnaire was administered to gauge physicians' self-reported behavior regarding lipid management aspects. Results were expressed in terms of percentages based on the number of responses obtained. RESULTS: A total of 404 physicians participated in the survey. Eighty-eight percent respondents ordered a lipid profile before starting statin therapy, and 80% preferred to set lipid targets, though the tools used for calculating cardiovascular risk varied. Atorvastatin was preferred over rosuvastatin in primary prevention (72.9 vs. 32.4%), secondary prevention (54.6 vs. 46.7%), diabetic patients (56.3 vs. 40.3%) and post-ACS (78.3 vs. 34%). High-intensity statins were preferred by 73.7% of respondents in post-ACS cases. Fifty percent doctors chose not to use a statin in diabetic patients, irrespective of their LDL-C levels. The most preferred drug option for managing atherogenic dyslipidemia and moderate hypertriglyceridemia was statin-fibrate combination (55.1%) and fibrates (35.4%), respectively. Sixty-three percent doctors preferred to prescribe statins in patients with moderately high LDL-C and normal triglycerides, without CHD or CHD risk equivalents. Around 28% of doctors preferred not to use pharmacotherapy for managing isolated low HDL. Of the participants, 73% used fibrates in ≤20% of their dyslipidemic patients, with fenofibrate being the most preferred (90.5%). Ezetimibe was mainly used in patients with uncontrolled LDL-C despite statin therapy (52.4% respondents). Most preferred approaches to manage statin intolerance included reducing statin dose (39%) and stopping and restarting statins at a lower dose (34.5%). Fifty-two percent of doctors chose not to alter pre-existing therapy in patients who had LDL-C levels at goal but elevated non-HDL-C levels. CONCLUSION: This is the first survey in India that provides useful insights into Indian physicians' self-reported perspectives on managing dyslipidemia in routine clinical practice. Despite concordance with the currently available guidelines in certain aspects, there is incongruence in managing specific dyslipidemia problems. Further continuing medical education and the development of evidence-based, India-specific lipid guidelines can help reduce some of these differences.

Effect of micronized fenofibrate on microvascular complications of type 2 diabetes: a systematic review.

OBJECTIVE: Micronized fenofibrate prevents the progression of microvascular complications in type 2 diabetes, but no systematic review has summarized these effects. Therefore, we performed a systematic review to investigate the effects of micronized fenofibrate on type 2 diabetes-related microvascular complications. RESEARCH DESIGN AND METHODS: The PubMed database was systematically searched for trials in English language published between January 1990 and November 2015 that examined the effects of fenofibrate on microvascular complications in patients with type 2 diabetes. RESULTS: Thirteen trials of the 290 clinical studies reviewed met the inclusion criteria. Fenofibrate significantly slowed the progression of early diabetic retinopathy by 30 to 40% within 4 to 5 years in patients with type 2 diabetes mellitus and pre-existing retinopathy at baseline. Fenofibrate also consistently reduced the progression of urinary albumin excretion in the trials studied. One large study demonstrated a significant effect (47% reduction) of the drug on diabetes-related minor amputations. CONCLUSIONS: The available evidence supports the adjunctive early use of fenofibrate in type 2 diabetes mellitus for the prevention of microvascular complications, particularly in individuals presenting with the first signs of the complication and during the initial stages of the disease.