Health Condition 1: null- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Intervention1: Glycopyrronium/Formoterol FDC: 25mcg/12mcg orally inhaled twice daily for 12 weeks
Control Intervention1: Glycopyrronium: 50mcg orally inhaled once daily for 12 weeks
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 65 years (both inclusive) 3. Subjects with moderate to severe COPD (GOLD 2015). Subjects should have a documented history of COPD and spirogram within at least the past 6 months 4. Post-bronchodilator FEV1 >= 40% and 5. Post bronchodilator FEV1/FVC ratio of 6. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking 7. Subjects having ability to use pMDI and DPI during the course of the study and able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to Glycopyrronium or Formoterol or Levosalbutamol or Budesonide or Ipratropium or any of its components 2. Subjects with any hospitalization required for exacerbation or any serious condition in the previous 12 weeks 3. Subjects who had more than two exacerbations in past 1 year 4. Use of systemic corticosteroids/antibiotics in prior 6 weeks 5. Subjects requiring oxygen therapy 6. Clinically significant ECG abnormality 7. Absolute Blood eosinophil count >600 cells/c mm of blood. 8. 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 9. History of asthma or any chronic respiratory disease other than COPD. 10. Occupational and non-smoking COPD 11. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within the previous 4 weeks. 12. History of lung resection of more than one full lobe. 13. Scheduled for in-patient hospitalization, including elective surgery during the trial. 14. Clinically significant laboratory values, as judged by the investigator. 15. History of clinically significant bladder neck obstruction or urinary retention 16. History of uncontrolled glaucoma 17. History of uncontrolled diabetes mellitus 18. Subjects receiving immunotherapy or live vaccine within past 1 year and inactivated vaccine within 1 month from screening visit 1 19. Participation in clinical trial in prior 4 weeks of screening visit 1. 20. Participation in clinical trial of Glycopyrronium alone or in combination within past 3 months of screening visit 1 21. Female who is pregnant or lactating or planning to be pregnant. 22. 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 |
|---|---|
| Mean change in pre dose trough FEV1Timepoint: At 12 weeks of treatment from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in average daily number of pMDI puffs of rescue medication consumedTimepoint: At 2, 4, 8 and 12 weeks of treatment from baseline;Mean change in 1 hour post dose FEV1 and FVCTimepoint: At 2, 4, 8 and 12 weeks of treatment from baseline;Mean change in CAT scoreTimepoint: At 4, 8 and 12 weeks of treatment from baseline;Mean change in COPD and Asthma Sleep Impact Scale (CASIS) scoreTimepoint: At 4, 8 and 12 weeks of treatment from baseline;Mean change in mMRC scaleTimepoint: At 4, 8 and 12 weeks of treatment from baseline;Mean change in pre dose trough FEV1Timepoint: At 2, 4, and 8 weeks of treatment from baseline;Mean change in pre dose trough FVCTimepoint: At 2, 4, 8 and 12 weeks of treatment from baseline | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd
Outcome results
None listed