A 12-week study to determine efficacy and safety of Glycopyrronium Formoterol combination through dry powder inhaler in patients with Chronic Obstructive Pulmonary Disease
- Conditions
- Health Condition 1: null- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- CTRI/2017/08/009286
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 356
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 <= 80% of the predicted normal value
5. Post bronchodilator FEV1/FVC ratio of <0.7
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method