Safety and efficacy of a fixed dose combination of glycopyrronium and formoterol fumarate dry powder inhaler (DPI) in patients with chronic obstructive pulmonary disease (COPD).

Phase 3

Completed

• Conditions: Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2017/02/007814
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 331

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified