A clinical study to evaluate the efficacy and safety of Vilanterol and Glycopyrronium metered dose inhalation in patients with Chronic Obstructive Pulmonary Disease.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2023/03/050167
- Lead Sponsor
- Zydus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 288
1. Patients of either gender between 40-65 years of age (both inclusive)
2. Patients who are current/ex-smokers
3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit:
a. Post-bronchodilator FEV1/FVC ratio < 0.7;
b. Post-bronchodilator FEV1, = 30% to < 80% predicted
4. Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
5. COPD Assessment Test (CAT) score = 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
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 formoterol, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
3. Patients diagnosed with COVID-19 within 3 months prior to screening
4. Patients with known a1 antitrypsin deficiency
5. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
6. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
7. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
8. Patients who required long-term oxygen therapy (=12 hours/day) within 4 weeks prior to the screening or during the screening period
9. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
11. Patients with hepatic dysfunction (serum transaminases = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in trough FEV1 at the end of the studyTimepoint: At baseline and Week 12
- Secondary Outcome Measures
Name Time Method Adverse events / Serious adverse events reported during the studyTimepoint: At Week 4, Week 8 and Week 12;Change from baseline in CAT™ score at week 4, week 8 and at the end of the studyTimepoint: At baseline, Week 4, Week 8 and Week 12;Change from baseline in post-bronchodilator FEV1 and FVC at week 4 and at the end of the studyTimepoint: At baseline, Week 4 and Week 12;Change from baseline in trough FEV1 at week 4Timepoint: At baseline and Week 4;Change from baseline in trough FVC at week 4 and at the end of the studyTimepoint: At baseline, Week 4 and Week 12;COPD exacerbations reported during the studyTimepoint: At Week 4, Week 8 and Week 12;Rescue medication use during the treatment period as compared to the baseline (screening period)Timepoint: At Screening period, Week 4, Week 8 and Week 12;Responder rate at week 4 and at the end of the studyTimepoint: At Week 4 and Week 12