NCT05217810Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 670 (actual)
- First submitted
- 30 Nov 2021
- Start date
- 9 May 2022
- Primary completion date
- 24 Dec 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Asthma
- NCT number
- NCT05217810
What you commit to
- Study type: Observational
- Participants enrolled: 670
- From 9 May 2022 to the primary completion date, 24 Dec 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 12 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.