Clinical trial NCT05274425: A 24-week rPMS Study in Real-world Setting for Enerzair
Official title: A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Enerzair
QVM149
Korea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received at least one dose of Enerzair inhalation capsule via Breezhaler and that have provided consent for their data collection.

Brief summary: This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

Detailed description: The two different doses of Enerzair 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 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

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

Primary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: 24 weeks
measure: Incidence of unexpected adverse events and unexpected serious adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in trough FEV1
timeFrame: Baseline, week 12
measure: Change from baseline in ACT score
timeFrame: Baseline, week 12
measure: Effective rate and ineffective rate by investigator assessment
timeFrame: week 12
measure: Baseline characteristics of patients showing adverse events
timeFrame: 24 weeks
measure: Baseline characteristics of patients showing adverse drug reactions
timeFrame: 24 weeks
measure: Baseline characteristics of patients in relation to changes from baseline in trough FEV1
timeFrame: 12 weeks
measure: Baseline characteristics of patients in relation to changes from baseline in trough ACT score
timeFrame: 12 weeks
measure: Baseline characteristics of patients in relation to the investigator assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cheongju si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungcheongbuk Do
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Dalseo Gu
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Deogyang Gu Goyang Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Bucheon-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-Do
city: Jeonju Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk Do
city: Suncheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollanam Do
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gyeongsangnam Do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: