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

Publication date: Available online 30 November 2019Source: Pulmonary Pharmacology & TherapeuticsAuthor(s): Aloke Ghoshal, Pradyut Waghray, George Dsouza, Mahip Saluja, Mayank Agarwal, Ashish Goyal, Sneha Limaye, Akash Balki, Sudhir Bhatnagar, Manish Jain, Sharad Tikkiwal, Abhijit Vaidya, Meena Lopez, Rashmi Hegde, Jaideep GogtayAbstractThe 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 sho...
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research