AsthmaNCT05217810
A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
An observational study of Asthma, run by Novartis Pharmaceuticals at 18 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- Atectura inhalation capsule (150/80ug), Atectura inhalation capsule (150/160ug) and Atectura inhalation capsule (150/320ug)
- Type of treatment
- Pill or oral medicine
- How many people
- 670 participants
- Where
- 18 sitesSouth Korea
- Study dates
- 9 May 2022to 24 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects who received at least one dose of Atectura inhalation capsule via Breezhaler and that have provided consent for their data collection.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Novartis Investigative Site
Busan, 48108
Novartis Investigative Site
Daegu, Dalseo gu, 42602
Novartis Investigative Site
Daejeon, Korea, 35015
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 10380
Novartis Investigative Site
Guri-si, Gyeonggi-do, 11923
Novartis Investigative Site
Gyeongsangnam Do, 51353
Novartis Investigative Site
Iksan Si, Jeonlabuk Do, 54538
Novartis Investigative Site
Jeju City, 63241
Novartis Investigative Site
Jeonju, Jeollabuk-do, 54907
Novartis Investigative Site
Jinju, Gyeongsangnam-do, 52727
Novartis Investigative Site
Kangwon Do, Gangneung si, 210 711
Novartis Investigative Site
Seoul, 04763
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06273
Novartis Investigative Site
Seoul, 137 707
Novartis Investigative Site
Taegu, 41944
Novartis Investigative Site
Ulsan, 44033
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426
About this study
Official title: 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)
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.
Read the detailed description
The three different doses of Atectura inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study
- Conditions
- Asthma
- Being tested
- Atectura inhalation capsule (150/80ug), Atectura inhalation capsule (150/160ug), Atectura inhalation capsule (150/320ug)
- Keywords
- Korea, ICS/LABA combination
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atectura inhalation capsule (150/80ug)Other
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
Atectura inhalation capsule (150/160ug)Other
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
Atectura inhalation capsule (150/320ug)Other
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Atectura inhalation capsule (150/80ug) | Indacaterol acetate/Mometasone furoate; 150/80ug Receives: Other: Atectura inhalation capsule (150/80ug) | |
| Atectura inhalation capsule (150/160ug) | Indacaterol acetate/Mometasone furoate; 150/160ug Receives: Other: Atectura inhalation capsule (150/160ug) | |
| Atectura inhalation capsule (150/320ug) | Indacaterol acetate/Mometasone furoate; 150/320ug Receives: Other: Atectura inhalation capsule (150/320ug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Incidence of AE and SAE will be collected
Measured: 24 weeks
Incidence of unexpected adverse events and unexpected serious adverse events
Incidence of unexpected AE and SAE will be collected. The term "unexpected" means not listed in local label
Measured: 24 weeks
Secondary outcomes (6)
change from baseline in trough FEV1
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Measured: Baseline, week 12
change from baseline in ACT score
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
Measured: Baseline, week 12
Effective rate and ineffective rate by investigator assessment
Effective (improved) rate and ineffective (unchanged/aggravated) rate by investigator assessment
Measured: week 12
Baseline characteristics of patients showing adverse events/adverse drug reactions
The incidence rates of AEs/ADRs will be presented by factors, such as subject baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. above 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.
Measured: 24 weeks
Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score
Regression analysis will be performed to determine factors affecting the change in trough FEV1 and ACT score, out of baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations
Measured: 12 weeks
Baseline characteristics of patients in relation to the investigator assessment
Logistic regression analysis will be performed to determine factors affecting the effectiveness (improved) in the investigator assessment, out of baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. above 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start9 May 2022
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217810
- Sponsor's protocol ID
- CQMF149EKR01
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT05217810
- Acronym / sponsor ID
- CQMF149EKR01
- Conditions
- Asthma
- Keywords
- Korea, ICS/LABA combination
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The three different doses of Atectura inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atectura inhalation capsule (150/80ug) | – | Other: Atectura inhalation capsule (150/80ug)Indacaterol acetate/Mometasone furoate; 150/80ug |
| Atectura inhalation capsule (150/160ug) | – | Other: Atectura inhalation capsule (150/160ug)Indacaterol acetate/Mometasone furoate; 150/160ug |
| Atectura inhalation capsule (150/320ug) | – | Other: Atectura inhalation capsule (150/320ug)Indacaterol acetate/Mometasone furoate; 150/320ug |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects who received at least one dose of Atectura inhalation capsule via Breezhaler and that have provided consent for their data collection.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 (150/80ug) |
| 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 (150/160ug) |
| 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. | Other | Atectura inhalation capsule (150/320ug) |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: 24 weeks
Incidence of AE and SAE will be collected
Incidence of unexpected adverse events and unexpected serious adverse events
Time frame: 24 weeks
Incidence of unexpected AE and SAE will be collected. The term "unexpected" means not listed in local label
6 secondary outcomes
change from baseline in trough FEV1
Time frame: Baseline, week 12
change from baseline in ACT score
Time frame: Baseline, week 12
Effective rate and ineffective rate by investigator assessment
Time frame: week 12
Baseline characteristics of patients showing adverse events/adverse drug reactions
Time frame: 24 weeks
Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score
Time frame: 12 weeks
Baseline characteristics of patients in relation to the investigator assessment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Novartis Pharmaceuticals at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.