Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J439- Emphysema, unspecified
Conditions
Interventions
Intervention1: Glycopyrronium/Formoterol/Budesonide (25mcg/12mcg/400mcg) fixed dose triple combination (FDC) twice daily: Dose: one rotacap twice daily,
Duration: Intervention duration 24 weeks,
Mode
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. A voluntarily given, written, signed, and dated informed consent from subject and/or legally acceptable representative. 2. Subjects of either gender and age between 40 and 75 years (both inclusive). 3. Subjects with a documented history of COPD (GOLD 2020 guidelines)-based on spirogram within past one year from screening. 4. Post-bronchodilator FEV1 greater than or equal to 30% and less than or equal to 80% of the predicted normal value. 5. Post-bronchodilator FEV1/FVC ratio of less than 0.7. 6. Subjects with CAT score greater than 10. 7. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking or subjects who had exposure to noxious stimuli which led to development of COPD. 8. Subjects having ability to use Revolizer® during course of the study and able to comply with protocol.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components. 2. Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening. 3. Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening. 4. Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening. 5. Clinically significant ECG abnormality. 6. 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. 7. History of asthma (rule out complete history and examination of asthma and/or post-bronchodilator FEV1 values greater than 400ml of predicted normal values) with persistent airflow limitation or history of atopy or any other chronic respiratory disease other than COPD. 8. Subjects on dual bronchodialator such as LABA/LAMA or SABA/SAMA or on tripe therapy for COPD within 3 months from screening. 9. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within past 4 weeks from screening. 10. History of lung resection of more than one full lobe. 11. Scheduled for in-patient hospitalization, including elective surgery during the trial. 12. Clinically significant laboratory values, as judged by the investigator. 13. History of clinically significant bladder neck obstruction or urinary retention. 14. History of glaucoma. 15. History of diabetes mellitus. 16. Participation in clinical trial in within past 4 weeks of screening. 17. Female who is pregnant or lactating or planning to be pregnant. 18. 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 (Serious/Non-Serious, Expected/Unexpected, Related/Not Related).Timepoint: 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in CAT score at week 6, week 12, week 18 and 24 from baseline. Mean change in pre-dose trough FEV1 and FVC at week 12 and 24 from baseline. Mean change in 2-hour post dose FEV1 and FVC at week 12 and 24 from baseline. Proportion of subjects with improvement in mMRC score at week 6, week 12, week 18 and week 24 from baseline. St Georgeâ??s Respiratory Questionnaire (SGRQ) at week 6, 12, 18 and 24. Timepoint: 24 Weeks | — |
Countries
India
Contacts
Public ContactAbhijit Vaidya
Cipla Ltd.
Outcome results
None listed