Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Vilanterol and Umeclidinium powder for Inhalation 25 mcg and 62.5 mcg DPI
: Patients will be dispensed one container/strips of 30 capsules each containing either the test drug or the re
Sponsors
Zydus Healthcare Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant of either gender between 40-75 years of age (both inclusive) at the time of screening visit. 2. Participant who is a current smoker/ex-smoker. 3. Participant 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 predicted 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. Participant with COPD Assessment Test (CATTM) score greater than or equals to 10 at screening. 6. Participant willing to provide written informed consent and comply with the protocol requirements. 7. Participant literate enough to fill the diary card.
Exclusion criteria
Exclusion criteria: 1. Participant suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 2. Participant with known hypersensitivity to umeclidinium, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents. 3. Participant 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. Participant hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period. 6. Participant has respiratory tract infections that required antibiotics within 4 weeks prior to the screening visit or during the screening period. 7. Participant who required long-term oxygen therapy (greater than or equals to 12 hours/day) within 4 weeks prior to the screening visit or during the screening period. 8. Participant with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention. 9. Participant with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 10. Participant with hepatic dysfunction (serum transaminases greater than or equals to 3 x Upper Normal Limit) at screening. 11. Participant with renal dysfunction (serum creatinine greater than or equals to 2.5 mg/dl) at screening. 12. Abnormal and clinically significant ECG findings at screening. 13. Participant who has used prohibited medications. 14. Participant with continuing history of alcohol and/or drug abuse. 15. Pregnant or Lactating females; or female participant of childbearing potential unwilling to use effective contraception. 16. Participation participated in another clinical trial in the past 3 months. 17. Any other reason for which the investigator feels that the participant should not participate. 18. Participant with Peak Inspiratory Flow Rate (PIFR) of less than 30 Liters per minute at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Change from baseline in trough FEV1 b. Change from baseline in trough FVC c. Change from baseline in post-bronchodilator FEV1 and FVC d. Change from baseline in the CAT score e. Responder rate: Proportion of f participants achieving improvement in trough FEV1 of greater than or equals to 100 ml as compared to trough FEV at the baseline f. Rescue medication useTimepoint: a. Week 4 b. Week 4 and at Week 12 c. Week 4 and at Week 12 d. Week 4, Week 8 and at Week 12 e. Week 4 and at Week 12 f. During treatment period as compared to baseline | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed