Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD) Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Glycopyrronium/formoterol fumarate dihydrate (12.5/12 mcg) DPI: Oral inhalation of the content of one capsule each twice daily (in the morning and evening) using the dry powder inhaler
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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 5. A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment (within 2 hours post-dose on Day 85) in peak FEV1(mL)Timepoint: Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in FVCTimepoint: Day 2, Day 15, Day 29, Day 57, and Day 85;Change from baseline in mean total daily symptom score, mean daytime total symptom score and mean night-time total symptom scoreTimepoint: Day 85;Change from baseline in standardized FEV1 AUC0-2hTimepoint: Day 85;Change from baseline in trough FEV1Timepoint: Day 2, Day 15, Day 29, Day 57, and Day 86 | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Limited
Outcome results
None listed