A clinical study to assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation in patients with Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2023/02/049362
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-14
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

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. COPD Assessment Test (CATTM) score = 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening

5. Patients willing to provide written informed consent and comply with the protocol requirements

6. Patients literate enough to fill the diary card

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 formoterol, vilanterol, glycopyrronium,

fluticasone, budesonide, 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