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)

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: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Atectura inhalation capsule (150/80ug); Other: Atectura inhalation capsule (150/160ug); Other: Atectura inhalation capsule (150/320ug)

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: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and serious adverse events	Incidence of AE and SAE will be collected	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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, week 12
Effective rate and ineffective rate by investigator assessment	Effective (improved) rate and ineffective (unchanged/aggravated) rate by investigator assessment	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.	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	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.	12 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Korea; ICS/LABA combination
• Other Study ID Numbers: CQMF149EKR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO