Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol and fluticasone in patients with COPD: a double-blind, randomised controlled trial
| Autor: | Saiprasad Patil, Hanmant Barkate, Shabbir Rangwala, Srikanth Krishnamurthy, Sagar Panchal, Amol Pendse, Wen Wu, Monika Tandon, Rahul Kodgule, Hitesh Khandagale, Akash Balki, Sundeep Salvi |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty Vital capacity Fluticasone propionate law.invention 03 medical and health sciences FEV1/FVC ratio 0302 clinical medicine Randomized controlled trial law Original Research Articles Internal medicine COPD Medicine 030212 general & internal medicine Fluticasone business.industry medicine.disease Clinical trial 030228 respiratory system Formoterol business medicine.drug |
| Zdroj: | ERJ Open Research, Vol 7, Iss 3 (2021) ERJ Open Research article-version (VoR) Version of Record |
| ISSN: | 2312-0541 |
| Popis: | Background The aim of this work was to investigate the safety and efficacy of single-inhaler triple therapy with 12.5 μg glycopyrronium (GB)/12 μg formoterol fumarate (FF)/250 μg fluticasone propionate (FP), compared to 50 μg GB co-administered with a fixed dose of 12 μg FF/250 μg FP in subjects with COPD. Methods This was a phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) Airz-FF (GB/FF/FP) is the first SITT combination launched in India for COPD. Its efficacy is comparable to open-triple therapy (GB+FF/FP); and it is safe and well tolerated in symptomatic COPD patients with history of exacerbations. https://bit.ly/33MHXVv |
| Databáze: | OpenAIRE |
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