Efficacy and safety of a fixed dose combination of Glycopyrronium/Formoterol/Fumarate/Fluticasone Propionate dry powder inhaler in patients with chronic obstructive pulmonary disease.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2019/01/017156
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 396
1. Male or female, aged >=40 to <=75 years at the time of informed consent
2. Current or previous cigarette/beedi smokers with a history of cigarette or beedi smoking of at least 10 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, 2017)
4. Post-bronchodilator FEV1/ FVC < 0.70 and post-bronchodilator FEV1>=30% predicted and <80% predicted, at screening visit.
5. History of at least two exacerbations of COPD within 12 months before screening.
6. A modified Medical Research Council dyspnoea (mMRC) grade 2 or greater.
7. Patients using inhaled corticosteroid (ICS) with or without a long-acting β2 agonist (LABA) (as a free or fixed combination), or ICS with long-acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening.
8. No significant abnormality suggesting chest disease other than COPD
1. A current or historic diagnosis of asthma.
2. Treatment with long-acting muscarinic agonist (LAMA), long-acting beta-agonist (LABA) and inhaled corticosteroids (ICS) in one or multiple inhalers, within 1 month before screening.
3. History of narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate-to-severe renal impairment or urinary retention (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate and, subjects who are asymptomatic and stable on pharmacological treatment for the condition will be considered for the study). Patients with post-void residue of >50 mL on ultrasonography at screening will be excluded from the study. Patients with an intra-ocular pressure of >21 mm of Hg in any eye, at screening will be excluded from the study.
4. Hospitalization for COPD exacerbation or pneumonia within 3 months prior to Visit 1.
5. 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, history of allergic rhinitis or atopy, pulmonary hypertension, and interstitial lung disease.
6. Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
7. Type I or uncontrolled Type II diabetes
8. 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).
Use of oral/depot corticosteroids or antibiotics for COPD exacerbation within 6 weeks prior to Visit 1 or subject has had a change in dose or type of any medications for COPD within 1 month before Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in trough FEV1 at the end of 12 weeks of treatmentTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in modified Medical Research Council (mMRC) scoreTimepoint: Week 12;Change from baseline in post-dose FEV1 at week 12 of treatment.Timepoint: Week 12;Change from baseline in trough forced vital capacity (FVC)Timepoint: Week 12;Compliance with the study medicationTimepoint: 14 weeks;Frequency of exacerbations in both the armsTimepoint: Week 0 to week 12;Frequency of hospitalization in both the armsTimepoint: Week 0 to Week 12;Number and percentage of patients with treatment emergent adverse events (TEAE)Timepoint: 14 Weeks;Rescue medication use averagedTimepoint: Week 11 and week 12