A study to assess the safety and effectiveness of Glycopyrronium / Formoterol fumarate / Budesonide Triple Therapy in the management of Chronic Obstructive Pulmonary Disease.

Phase 4

Conditions: Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Registration Number: CTRI/2023/10/058675

Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients more than or equal to 40 years’ age with a documented physician diagnosis of COPD. 2. Symptomatic patients receiving ongoing maintenance therapy (ICS/LABA or LAMA or LABA/LAMA). 3. Patients with exacerbation history in past 1 year. 4. Ability to use MDI/DPI independently and correctly in view of the investigator. 5. Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol.

Exclusion Criteria

1. Documented diagnosis of current asthma.

2. Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.

3. Subjects with any life threatening condition or requiring hospitalization for management of current condition.

4. Women of childbearing potential are not restricted in this study, however it is expected

that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.

5. Subjects with history of hypersensitivity to the active substance or to any of its excipients

of study drug.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of GFB MDI/DPI in treatment of patients with COPD in India in terms of - <br/ ><br>Number of patients with any drug related treatment emergent adverse events (TEAEs). [Time frame: up to Week 24] <br/ ><br>Number of patients with TEAEs [Time Frame: up to Week 24] <br/ ><br>Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 24]Timepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of GFB MDI/DPI in treatment of patients with COPD in India in terms of - <br/ ><br>Mean change in Trough FEV1 from baseline at week 24. <br/ ><br>Mean change in mMRC score from baseline at week 24. <br/ ><br>Number of patients with exacerbations (mild/moderate/severe) over 24 weeks. <br/ ><br>Proportion of patients requiring hospitalization [Time frame: upto 24 weeks] <br/ ><br>Rescue medication use averaged over 24 weeks of treatment. <br/ ><br>Compliance with the study medication. [Time frame: At week 24] <br/ ><br>Assessment of patients satisfaction with the treatment [Time frame: Upto 24 weeks] <br/ ><br>Assessment of physicians satisfaction with the treatment[Time frame: Upto 24 weeks]Timepoint: 24 weeks