PMID- 31794836 OWN - NLM STAT- MEDLINE DCOM- 20210212 LR - 20210212 IS - 1522-9629 (Electronic) IS - 1094-5539 (Linking) VI - 60 DP - 2020 Feb TI - Real-world evaluation of the clinical safety and efficacy of fluticasone/formoterol FDC via the Revolizer(R) in patients with persistent asthma in India. PG - 101869 LID - S1094-5539(19)30184-1 [pii] LID - 10.1016/j.pupt.2019.101869 [doi] AB - The combination of inhaled corticosteroids (ICS) and long-acting beta(2)-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(R) 100/6 mcg or 250/6 mcg) capsules via the Revolizer(R) 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(R) 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(R)) offers a novel, well-tolerated and effective treatment option for the long-term management of asthma. CI - Copyright (c) 2019 Elsevier Ltd. All rights reserved. FAU - Ghoshal, Aloke AU - Ghoshal A AD - National Allergy Asthma Bronchitis Institute, Kolkata, India. Electronic address: agghosal@yahoo.co.in. FAU - Waghray, Pradyut AU - Waghray P AD - Eesha Multispecialty Hospital, Hyderabad, India. Electronic address: pradyut_waghray@rediffmail.com. FAU - Dsouza, George AU - Dsouza G AD - St. Johns Medical College and Hospital, Bengaluru, India. Electronic address: dsouza.ga1975@gmail.com. FAU - Saluja, Mahip AU - Saluja M AD - Subarthi Medical College, Meerut, India. Electronic address: drmahip@hotmail.com. FAU - Agarwal, Mayank AU - Agarwal M AD - Om Surgical Center & Maternity Home, Varanasi, India. Electronic address: dr.mayankag@yahoo.com. FAU - Goyal, Ashish AU - Goyal A AD - Medipoint Hospital, Pune, India. Electronic address: ashish_critical@yahoo.co.in. FAU - Limaye, Sneha AU - Limaye S AD - Chest Research Foundation, Pune, India. Electronic address: snehalimaye@crfindia.com. FAU - Balki, Akash AU - Balki A AD - Shree Hospital and Critical Care, Nagpur, India. Electronic address: akash_balki@yahoo.com. FAU - Bhatnagar, Sudhir AU - Bhatnagar S AD - Abhinav Multispecialty Hospital, Nagpur, India. Electronic address: drsudhirbhatnagar@gmail.com. FAU - Jain, Manish AU - Jain M AD - Navkar, Jaipur, India. Electronic address: doctormanishjain2@gmail.com. FAU - Tikkiwal, Sharad AU - Tikkiwal S AD - Asthma Bhavan, Jaipur, India. Electronic address: sharadtikkiwal@gmail.com. FAU - Vaidya, Abhijit AU - Vaidya A AD - Medical Dept, Cipla Ltd, Mumbai, India. Electronic address: abhijit.vaidya@cipla.com. FAU - Lopez, Meena AU - Lopez M AD - Medical Dept, Cipla Ltd, Mumbai, India. Electronic address: meena@cipla.com. FAU - Hegde, Rashmi AU - Hegde R AD - Medical Dept, Cipla Ltd, Mumbai, India. Electronic address: Rashmi.Hegde@Cipla.com. FAU - Gogtay, Jaideep AU - Gogtay J AD - Medical Dept, Cipla Ltd, Mumbai, India. Electronic address: jgogtay@cipla.com. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20191130 PL - England TA - Pulm Pharmacol Ther JT - Pulmonary pharmacology & therapeutics JID - 9715279 RN - 0 (Bronchodilator Agents) RN - 0 (Drug Combinations) RN - 0 (fluticasone-formoterol) RN - CUT2W21N7U (Fluticasone) RN - W34SHF8J2K (Formoterol Fumarate) SB - IM MH - Administration, Inhalation MH - Adult MH - Aged MH - Aged, 80 and over MH - Asthma/*drug therapy MH - Bronchodilator Agents/*adverse effects/*therapeutic use MH - Drug Combinations MH - Dry Powder Inhalers MH - Female MH - Fluticasone/*adverse effects/*therapeutic use MH - Formoterol Fumarate/*adverse effects/*therapeutic use MH - Humans MH - India MH - Male MH - Middle Aged MH - Peak Expiratory Flow Rate MH - Prospective Studies MH - Surveys and Questionnaires OTO - NOTNLM OT - Airway inflammation OT - Asthma OT - DPI OT - Dry powder inhaler OT - FDC OT - Fixed-dose combination OT - Fluticasone/formoterol OT - PEFR OT - Peak expiratory flow rate EDAT- 2019/12/04 06:00 MHDA- 2021/02/13 06:00 CRDT- 2019/12/04 06:00 PHST- 2019/08/13 00:00 [received] PHST- 2019/11/25 00:00 [revised] PHST- 2019/11/25 00:00 [accepted] PHST- 2019/12/04 06:00 [pubmed] PHST- 2021/02/13 06:00 [medline] PHST- 2019/12/04 06:00 [entrez] AID - S1094-5539(19)30184-1 [pii] AID - 10.1016/j.pupt.2019.101869 [doi] PST - ppublish SO - Pulm Pharmacol Ther. 2020 Feb;60:101869. doi: 10.1016/j.pupt.2019.101869. Epub 2019 Nov 30.