Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Glycopyrronim and Indacaterol inhalation 25 mcg and 55 mcg: Participants will be dispensed one MDI each of Glycopyrronium and Indacaterol inhalation 25 mcg and 55 mcg during visit 2 (da
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either gender between 40-65 years of age (both inclusive) 2. Participants who are current/ex-smokers 3. Participants diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a. Post-bronchodilator FEV1/FVC ratio less than 0.7; b. Post-bronchodilator FEV1, greater than or equals to 30 percent to less than 80 percent predicted 4. Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period 5. COPD Assessment Test (CAT) score greater than or equals to 10 at screening 6. Participants willing to provide written informed consent and comply with the protocol requirements 7. Participants literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. Participants suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 2. Participants with known hypersensitivity to indacaterol, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents 3. Participants with known alpha 1 antitrypsin deficiency 4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 5. Participants hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 7. Participants who required long-term oxygen therapy (greater than or equals to 12 hours/day) within 4 weeks prior to the screening or during the screening period 8. Participants with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder neck obstruction or urinary retention. 9. Participants with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 10. Participants with hepatic dysfunction (serum transaminases greater than or equals to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater than or equals to 2.5 mg/dl) at screening 11. Participants who have used prohibited medications 12. Participants with continuing history of alcohol and/or drug abuse 13. Pregnant or Lactating females; or female participants of childbearing potential or male participants unwilling to use effective contraception during and 1 month after completion of the study. Male participants who are unwilling to not donate sperm for the purpose of reproduction. 14. Participant participated in any clinical trial in the past 3 months 15. Any other reason for which the investigator feels that the participant should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: At week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in trough FEV1 2. Change from baseline in trough FVC 3. Change from baseline in post-bronchodilator FEV1 and FVC 4. Change from baseline in CAT score 5. Responder rate 6. Rescue medication use 7. COPD exacerbations 8. Global impression of change in the disease condition of participants Timepoint: 1. At week 4 2. At week 4 & At week 12 3. At week 4 & At week 12 4. At week 4, week 8 and at week 12 5. At week 4 and at week 12 6. During the treatment period as compared to the baseline 7. During the study 8. At week 12 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed