A 12 week treatment, multi-centre, randomized, double-blind, parallel-group, active controlled study to assess the efficacy, safety, and tolerability of a fixed dose combination of glycopyrronium (12.5 mcg)/ formoterol fumarate dihydrate (12 mcg) in a dry powder inhaler in comparison with Glenmark AirzTM Glycopyrronium powder for inhalation 50 mcg in subjects with chronic obstructive pulmonary disease

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 331 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1.Male or female, aged between 40 to 65 years at the time of informed consent
•2.Current or previous cigarette/beedi smokers with a history of cigarette or beedi smoking of at least10 pack-years (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
•3.Diagnosis of COPD ( as defined by the GOLD Guidelines, 2016)
•4.Post-bronchodilator FEV1 >= 30% and < 80% of the predicted normal value and post-bronchodilator FEV1/ FVC (forced vital capacity) ratio < 0.7
•5.A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater.

•1.Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
•2.Chest X-ray or CT scan, which reveals evidence of clinically significant abnormalities, not believed to be due to the presence of COPD (e.g., evidence of pneumonia, other infection, atelectasis, or pneumothorax).
•3.Type I or uncontrolled Type II diabetes.
•4.Pregnant or lactating women.
•5.Currently enrolled in another clinical study or have used any IPs, study drug, or device within 30 days or 5 times the half-life, whichever is longer preceding informed consent or scheduled to participate in another clinical study involving an IP.

发起方

Glenmark Pharmaceuticals Ltd