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Recruiting NCT05274425

A 24-week rPMS Study in Real-world Setting for Enerzair

Trial Parameters

Condition Asthma
Sponsor Novartis Pharmaceuticals
Study Type OBSERVATIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2022-05-09
Completion 2027-03-11
Interventions
Enerzair 150/50/80 μgEnerzair 150/50/160 μg

Brief Summary

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

Eligibility Criteria

Inclusion Criteria: 1. Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 μg) via Breezhaler, as per the approved label information 2. Patients who participate in the study after signing the consent form for data collection and use (Data Privacy ICF) after receiving a clear explanation of the objectives and nature of the study from the investigator Exclusion Criteria: 1. Patients who are contraindicated for this medicinal product as described in the Precautions for Use in the label information (package insert) A. Patients with hypersensitivity reaction to this medicinal product or any of its constituents B. Because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc. 2. Patients with acute asthma symptoms, including

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