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)

ClinicalTrials.gov Identifier: NCT05217810

Novartis Reference Number: CQMF149EKR01

Last Update: Feb 06, 2023

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Asthma
Phase 
Not Given
Overall status 
Recruiting
Start date 
May 09, 2022
Completion date 
Dec 23, 2026
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Other
Atectura 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.
Other
Atectura 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.
Other
Atectura 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.

Eligibility Criteria

Inclusion Criteria:

Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 μg) via Breezhaler, as per the approved label information
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 (For patients under the age of 18, consent and signature of a legal representative is required)

Exclusion Criteria:

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.
Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
Patients participating in other interventional clinical trials

Study Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu, 42602
Dalseo Gu
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 
[email protected]

Have a question?

Call 1-888-669-6682 or email [email protected]