RecruitingNCT05274425

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

A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)

Sponsor

Novartis Pharmaceuticals

Enrollment

600 participants

Start Date

May 9, 2022

Study Type

OBSERVATIONAL

Conditions

Asthma

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world observational study (registry) tracking patients with asthma who have been prescribed Enerzair — a triple-combination inhaler containing three medications (indacaterol, glycopyrronium, and mometasone) — to see how it performs in everyday clinical practice. **You may be eligible if...** - You are 18 or older with a physician-confirmed asthma diagnosis - You have been prescribed Enerzair by your doctor according to its approved label - You have consented to data collection **You may NOT be eligible if...** - You are contraindicated for Enerzair (e.g., allergy to any of its components) - You have hereditary lactose intolerance (the inhaler contains lactose) - You are experiencing an acute asthma attack at enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREnerzair 150/50/80 μg

There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.

OTHEREnerzair 150/50/160 μg

There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.

Locations(20)

Novartis Investigative Site

Daegu, Dalseo gu, South Korea

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Goyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Novartis Investigative Site

Suncheon, Jeollanam-do, South Korea

Novartis Investigative Site

Cheongju-si, North Chungcheong, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Daegu, South Korea

Novartis Investigative Site

Gwangju, South Korea

Novartis Investigative Site

Gyeonggi-do, South Korea

Novartis Investigative Site

Gyeongsangnam Do, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05274425

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