Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: FDC of Glycopyrronium & Formoterol Fumarate Inhaler (12.5 mcg + 6 mcg): Metered Dose Inhaler, two inhalations twice daily (Morning and Evening) for 12 weeks
Control Intervention1: None:
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 A voluntarily given written, signed, and dated informed consent from subjects 2 Subjects of either gender 40 years or above 3 Subjects with a documented history of COPD based on spirogram and in compliance to the GOLD 2025 guidelines 4 Subjects with Post-bronchodilator FEV1 greater than or equal to 30% of the predicted normal value and Post-bronchodilator FEV1/FVC ratio of less than 0.7 5 Subjects with CAT score greater than or equal to 10 6 Subject with current or past cigarette smoking history or exposure to noxious stimuli 7 Subject should be able to correctly use the pressurised metered dose inhaler pMDI
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to glycopyrronium or formoterol fumarate or any of its components. 2. Subjects receiving dual therapy (LABA + LAMA), triple therapy (ICS+LABA+LAMA) (fixed dose or free combination) for COPD within 3 months from screening. 3. Subjects with hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening. 4. Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening. 5. Clinically significant neurologic, cardiovascular, hepatic, renal, endocrine, pulmonary (post-tuberculosis fibrosis, pulmonary fibrotic disease, pulmonary arterial hypertension), hematologic, psychiatric, or other medical illness that will interfere with participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events including Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs).Timepoint: Baseline, Week 6 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in CAT score at week 6 and week 12 from baselineTimepoint: Week 6 and week 12;Mean change in trough FVC at week 6 and week 12 from baselineTimepoint: Week 6 and week 12;Mean change in COPD and Asthma Sleep Impact Scale (CASIS) score at week 6 and week 12 from baselineTimepoint: Week 6 and week 12;Mean change in trough FEV1 at week 6 and week 12 from baselineTimepoint: Week 6 and week 12;Proportion of patients with reduction in mMRC grade at week 6 and week 12 from baselineTimepoint: Week 6 and week 12 | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed