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

August 6, 2025 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Novartis Investigative Site
      • Gyeongsangnam Do, Korea, Republic of, 630-522
        • Completed
        • Novartis Investigative Site
      • Jeju, Korea, Republic of, 63241
        • Recruiting
        • Novartis Investigative Site
      • Jinju, Korea, Republic of, 660-702
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 137 707
        • Recruiting
        • Novartis Investigative Site
      • Taegu, Korea, Republic of, 41944
        • Recruiting
        • Novartis Investigative Site
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • Novartis Investigative Site
    • Dalseo gu
      • Daegu, Dalseo gu, Korea, Republic of, 42602
        • Recruiting
        • Novartis Investigative Site
    • Gangneung si
      • Kangwon Do, Gangneung si, Korea, Republic of, 210 711
        • Completed
        • Novartis Investigative Site
    • Gangwon-Do
      • Wonju, Gangwon-Do, Korea, Republic of, 26426
        • Active, not recruiting
        • Novartis Investigative Site
    • Gyeonggi Do
      • Guri Si, Gyeonggi Do, Korea, Republic of, 471-701
        • Completed
        • Novartis Investigative Site
    • Gyeonggi do
      • Goyang si, Gyeonggi do, Korea, Republic of, 10380
        • Recruiting
        • Novartis Investigative Site
    • Jeollabuk do
      • Jeonju si, Jeollabuk do, Korea, Republic of, 561 712
        • Recruiting
        • Novartis Investigative Site
    • Jeonlabuk do
      • Iksan si, Jeonlabuk do, Korea, Republic of, 570-711
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Daejeon, Korea, Korea, Republic of, 35015
        • Completed
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

subjects who received at least one dose of Atectura inhalation capsule via Breezhaler and that have provided consent for their data collection.

Description

Inclusion Criteria:

  1. 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
  2. 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:

  1. 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.
  2. Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
  3. Patients participating in other interventional clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Atectura inhalation capsule (150/80ug)
Indacaterol acetate/Mometasone furoate; 150/80ug
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.
Atectura inhalation capsule (150/160ug)
Indacaterol acetate/Mometasone furoate; 150/160ug
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.
Atectura inhalation capsule (150/320ug)
Indacaterol acetate/Mometasone furoate; 150/320ug
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: 24 weeks
Incidence of AE and SAE will be collected
24 weeks
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
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in trough FEV1
Time Frame: Baseline, week 12
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Baseline, week 12
change from baseline in ACT score
Time Frame: Baseline, week 12
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.
Baseline, week 12
Effective rate and ineffective rate by investigator assessment
Time Frame: week 12
Effective (improved) rate and ineffective (unchanged/aggravated) rate by investigator assessment
week 12
Baseline characteristics of patients showing adverse events/adverse drug reactions
Time Frame: 24 weeks
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.
24 weeks
Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score
Time Frame: 12 weeks
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
12 weeks
Baseline characteristics of patients in relation to the investigator assessment
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQMF149EKR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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