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.
Study Type
OBSERVATIONAL
Enrollment
600
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.
Novartis Investigative Site
Daegu, Dalseo Gu, South Korea
RECRUITINGNovartis Investigative Site
Wŏnju, Gangwon-do, South Korea
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.
Novartis Pharmaceuticals
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Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea
WITHDRAWNNovartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Deogyang Gu Goyang Si, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Jeonju, Jeollabuk-do, South Korea
RECRUITINGNovartis Investigative Site
Suncheon, Jeollanam-do, South Korea
RECRUITINGNovartis Investigative Site
Cheongju-si, North Chungcheong, South Korea
RECRUITINGNovartis Investigative Site
Busan, South Korea
RECRUITINGNovartis Investigative Site
Daegu, South Korea
RECRUITING...and 6 more locations
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