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

Phase 4

Active, not recruiting

• Conditions: Asthma,

• Registration Number: CTRI/2023/12/060605
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

The study is a prospective, open label, multicentre, single arm, interventional, phase IV study to evaluate the safety and effectiveness of IND/MF/GLY DPI in the management of Asthma among Indian patients. Adult patient with uncontrolled Asthma will be enrolled in the study. Clinical diagnosis of Asthma will be as per the standard definition by GINA 2022. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. Treatment duration is 12 weeks and patients will be followed-up till the end of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-29
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• a.Patients ≥18 years of age with a documented physician diagnosis of Asthma b.
• ACQ-5 score ≥ 1.5 at baseline.
• History of one or more asthma exacerbations in last one year.
• Ability to use dry powder inhaler independently and correctly in view of the investigator.
• 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

• History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
• Smoking history of more than 10 pack-years.
• Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
• Subjects with any life threatening condition.
• 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.
• 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
Number of patients with serious TEAEs (STEAEs)	At week 12
To evaluate the safety of IND/MF/GLY DPI in treatment of Asthma in Indian population	At week 12
Number of patients with any drug related treatment emergent adverse events (TEAEs).	At week 12
Number of patients with TEAEs	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	Mean change in Trough FEV1 from baseline

Trial Locations

Locations (5)

All India Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Citizen Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

New Leelamani Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and General Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

All India Institute of Medical Sciences

🇮🇳Patna, BIHAR, India

Dr Saurabh Karmakar

Principal investigator

7783892746

drkarmakar01@gmail.com