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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enerzair 150/50/80 μg | Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/80 μg) via Breezhaler |
| |
| Enerzair 150/50/160 μg | Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/160 μg) via Breezhaler, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enerzair 150/50/80 μg | Other | There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | Incidence of AE and SAE to be collected | 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. | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received at least one dose of Enerzair inhalation capsule via Breezhaler and that have provided consent for their data collection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Daegu | Dalseo gu | 42602 | South Korea | |
| Novartis Investigative Site |
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| Enerzair 150/50/160 μg | Other | There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled. |
|
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 | 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. | 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. | 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. | 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. | 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. | 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 |
| Recruiting |
| Wŏnju |
| Gangwon-do |
| 26426 |
| South Korea |
| Novartis Investigative Site | Completed | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Recruiting | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Completed | Goyang-si | Gyeonggi-do | 10475 | South Korea |
| Novartis Investigative Site | Recruiting | Jeonju | Jeollabuk-do | 561 712 | South Korea |
| Novartis Investigative Site | Completed | Suncheon | Jeollanam-do | 540-719 | South Korea |
| Novartis Investigative Site | Active, not recruiting | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 49201 | South Korea |
| Novartis Investigative Site | Recruiting | Daegu | 705703 | South Korea |
| Novartis Investigative Site | Recruiting | Gwangju | 501171 | South Korea |
| Novartis Investigative Site | Active, not recruiting | Gyeonggi-do | 14353 | South Korea |
| Novartis Investigative Site | Recruiting | Gyeongsangnam Do | 630-522 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Active, not recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06273 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 2447 | South Korea |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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