study to assess the efficacy and safety of Glycopyrronium and Indacaterol inhalation in patients with Chronic Obstructive Pulmonary Disease.

Phase 3

Not yet recruiting

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2025/06/089209
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

A Prospective, Randomized,Double-blind, Parallel, Active-controlled, Multicentre, Phase III clinicaltrial to assess the efficacy and safety of Glycopyrronium and Indacaterolinhalation as compared to Vilanterol and Glycopyrronium inhalation in patientswith Chronic Obstructive Pulmonary Disease.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-13
• Study Start: 2025-06-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• 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 literate enough to fill the diary card.

Exclusion Criteria

• Participants suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
• 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.
• 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.
• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in trough FEV1	At week 12

Secondary Outcome Measures

Name	Time	Method
1. Change from baseline in trough FEV1	2. Change from baseline in trough FVC

Trial Locations

Locations (5)

Belagavi Institute of Medical Sciences; 🇮🇳 Belgaum, KARNATAKA, India

Bhate Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Hi-Tech Medical College and Hospital; 🇮🇳 Khordha, ORISSA, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Murarilal Chest Hospital, GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Belagavi Institute of Medical Sciences

🇮🇳Belgaum, KARNATAKA, India

Dr Santosh Honnavar

Principal investigator

9964451057

Honnavar.santosh@gmail.com