A study to evaluate the safety and efficacy of Indacaterol, Mometasone, Glycopyrronium Dry powder inhaler in Asthma patients.

Phase 4

Conditions: Health Condition 1: J45- Asthma

Registration Number: CTRI/2023/12/060605

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

a.Patients =18 years of age with a documented physician diagnosis of Asthma

b. Symptomatic patients on ongoing maintenance therapy with ICS/LABA or ICS/FOR

c. ACQ-5 score = 1.5 at baseline.

d. History of one or more asthma exacerbations in last one year.

e. Ability to use dry powder inhaler independently and correctly in view of the investigator.

f. 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

a. History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).

b. Smoking history of more than 10 pack-years.

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

d. Subjects with any life threatening condition.

e. 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.

f. 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 IND/MF/GLY DPI in treatment of Asthma in Indian population <br/ ><br> <br/ ><br>Number of patients with any drug related treatment emergent adverse events (TEAEs). <br/ ><br>Number of patients with TEAEs <br/ ><br>Number of patients with serious TEAEs (STEAEs)Timepoint: At week 12

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of IND/MF/GLY DPI in treatment of Asthma in Indian population <br/ ><br>Mean change in Trough FEV1 from baseline <br/ ><br>Mean change in ACQ-5 score from baseline <br/ ><br>Percentage change in ACQ-5 score at week 4 and 12 from baseline.Timepoint: At week 12