Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: FDC of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) inhaler [pMDI]: Two inhalations twice a daily
Intervention2: FDC of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/
Sponsors
Cipla Ltd
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.4. Post-bronchodilator FEV1 greater than or equal to 30 percent and less than or equal to 80 percent of the predicted normal value.5. Post-bronchodilator FEV1/FVC ratio of less than 0.7.6. Subjects with CAT score greater than or equal to 10.7. Current or ex-smoker of at least 10 pack years of cigarette/ bidi smoking or subjects who had exposure to noxious stimuli.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to glycopyrronium or formoterol or budesonide or any of its components. 2. Subjects receiving 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. Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening. 6. Clinically significant ECG abnormality (QTcF greater than 500msec) at screening. 7. History of clinically significant bladder neck obstruction or urinary retention 8. History of uncontrolled glaucoma. 9. History of uncontrolled diabetes mellitus. 10. Female who is pregnant or lactating or planning to be pregnant 11. Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE).Timepoint: Screening, Baseline, Week 6 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in CAT score at week 6 and week 12 from baseline. Mean change in through FEV1 and FVC at week 12 from baseline.Timepoint: Total 3 Timepoint Baseline, Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed