RecruitingNCT05217810

A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®

A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura® (QMF149 150/80 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d. Via Breezhaler)


Sponsor

Novartis Pharmaceuticals

Enrollment

600 participants

Start Date

May 9, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 12 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how well the Atectura inhaler (indacaterol/mometasone — a combination of a long-acting bronchodilator and a steroid) works for asthma patients in real-world clinical settings over 24 weeks. It is an observational study, meaning no new treatment is being tested — researchers are simply tracking outcomes of patients already prescribed this medication. **You may be eligible if...** - You are 12 years old or older and have been diagnosed with asthma by a doctor - You have been prescribed Atectura inhaler by your doctor as part of your regular care - You have consented to your data being collected for research purposes **You may NOT be eligible if...** - You have a known allergy to any ingredient in the inhaler - You have a hereditary problem with lactose digestion - You are currently having an acute asthma attack requiring a rescue inhaler - You are enrolled in another interventional clinical trial 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

OTHERAtectura inhalation capsule (150/80ug)

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

OTHERAtectura inhalation capsule (150/160ug)

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

OTHERAtectura inhalation capsule (150/320ug)

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


Locations(18)

Novartis Investigative Site

Daegu, Dalseo gu, South Korea

Novartis Investigative Site

Kangwon Do, Gangneung si, South Korea

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Novartis Investigative Site

Goyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Guri-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Novartis Investigative Site

Iksan Si, Jeonlabuk Do, South Korea

Novartis Investigative Site

Daejeon, Korea, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Gyeongsangnam Do, South Korea

Novartis Investigative Site

Jeju City, South Korea

Novartis Investigative Site

Jinju, 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

Taegu, South Korea

Novartis Investigative Site

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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NCT05217810


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