An observational study in Asthma, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 21 sites in South Korea. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 683 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who received at least one dose of Enerzair inhalation capsule via Breezhaler and that have provided consent for their data collection.
Exclusion Criteria:
Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/80 μg) via Breezhaler
Other: Enerzair 150/50/80 μg
Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/160 μg) via Breezhaler,
Other: Enerzair 150/50/160 μg
There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.
There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.
Incidence of adverse events and serious adverse events
Incidence of AE and SAE to be collected
Time frame: 24 weeks
Incidence of unexpected adverse events and unexpected serious adverse events
Incidence of unexpected AE and SAE. The term "unexpected" means not listed in local label.
Time frame: 24 weeks
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.
Time frame: 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.
Time frame: Baseline, week 12
Effective rate and ineffective rate by investigator assessment
The investigator comprehensively and subjectively evaluates the therapeutic effect of a treatment. The investigators can select effective, if they think patient's symptom was improved or ineffective, if they think patient's symptom was unchanged/aggravated.
Time frame: week 12
Baseline characteristics of patients showing adverse events
The incidence rates of AEs 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.
Time frame: 24 weeks
Baseline characteristics of patients showing adverse drug reactions
The incidence rates of 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.
Time frame: 24 weeks
Baseline characteristics of patients in relation to changes from baseline in trough FEV1
Regression analysis will be performed to determine factors affecting the change in trough FEV1, 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.
Time frame: 12 weeks
Baseline characteristics of patients in relation to changes from baseline in trough ACT score
Regression analysis will be performed to determine factors affecting the change in trough 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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