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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 Atectura inhalation capsule for up to 24 weeks under routine clinical practice.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atectura inhalation capsule (150/80ug) | Indacaterol acetate/Mometasone furoate; 150/80ug |
| |
| Atectura inhalation capsule (150/160ug) | Indacaterol acetate/Mometasone furoate; 150/160ug |
| |
| Atectura inhalation capsule (150/320ug) | Indacaterol acetate/Mometasone furoate; 150/320ug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atectura inhalation capsule (150/80ug) | Other | There is no treatment allocation. Patients administered Atectura 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 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 |
| 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 Atectura 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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| Atectura inhalation capsule (150/160ug) | Other | 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) | Other | There is no treatment allocation. Patients administered Atectura 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 | 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 |
| Completed |
| Kangwon Do |
| Gangneung si |
| 210 711 |
| South Korea |
| Novartis Investigative Site | Active, not recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
| Novartis Investigative Site | Recruiting | Goyang-si | Gyeonggi-do | 10380 | South Korea |
| Novartis Investigative Site | Completed | Guri-si | Gyeonggi-do | 471-701 | South Korea |
| Novartis Investigative Site | Recruiting | Jeonju | Jeollabuk-do | 561 712 | South Korea |
| Novartis Investigative Site | Recruiting | Iksan Si | Jeonlabuk Do | 570-711 | South Korea |
| Novartis Investigative Site | Completed | Daejeon | Korea | 35015 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 48108 | South Korea |
| Novartis Investigative Site | Completed | Gyeongsangnam Do | 630-522 | South Korea |
| Novartis Investigative Site | Recruiting | Jeju City | 63241 | South Korea |
| Novartis Investigative Site | Recruiting | Jinju | 660-702 | 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 | 137 707 | South Korea |
| Novartis Investigative Site | Recruiting | Taegu | 41944 | South Korea |
| Novartis Investigative Site | Recruiting | Ulsan | 44033 | 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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