Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Umeclidinium and Vilanterol Inhalation: Dose:12.5 mcg and 31.25 mcg MDI Route:Oral inhalation Duration:Day 0 to Day 84 Frequency: 2actuations/once daily
Control Intervention1: Vilantero
Sponsors
Zydus Healthcare Limited,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender between 40-75 years of age (both inclusive) 2.Patients who are current/ex-smokers 3.Patients diagnosed with moderate to very 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 less than 80 percentage predicted 4.Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period 5.COPD Assessment Test (CATTM) score greater than equal to 10 at screening 6.Patients willing to provide written informed consent and comply with the protocol requirements 7.Patients literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 2.Patients with known hypersensitivity to umeclidinium, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents 3.Patients with known alpha1 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.Patients 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.Patients who required long-term oxygen therapy (greater than equal to 12 hours per day) within 4 weeks prior to the screening or during the screening period 8.Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 9.Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 10.Patients with hepatic dysfunction (serum transaminases greater than equal to 3x Upper Normal Limit) or renal dysfunction (serum creatinine greater than equal to 2.5 mg/dl) at screening 11.Abnormal and clinically significant ECG findings at screening 12.Patients who have used prohibited medications 13.Patients with continuing history of alcohol and/or drug abuse 14.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 15.Participation in another clinical trial in the past 3 months 16.Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at the end of the studyTimepoint: Baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at week 4Timepoint: Baseline to week 4;Change from baseline in trough FVC at week 4 and at the end of the studyTimepoint: Baseline to week 4 and end of study;Change from baseline in post-bronchodilator FEV1 and FVC at week 4 and at the end of the studyTimepoint: Baseline to week 4 and end of study;Change from baseline in CAT score at week 4, week 8 and at the end of the studyTimepoint: Baseline to week 4, week 8 and end of study;Responder rate at week 4 and at the end of the studyTimepoint: Baseline to week 4 and end of study;Rescue medication use during the treatment period as compared to the baseline (screening period)Timepoint: Baseline to end of study;Adverse events reported during the studyTimepoint: Baseline to end of study;Serious adverse events reported during the studyTimepoint: Baseline to end of study;COPD exacerbations reported during the studyTimepoint: Baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Hardik Pathak
Zydus Research Centre
Outcome results
None listed