A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
Recruiting · NCT05217810 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
Atectura inhalation capsule (150/160ug)Atectura inhalation capsule (150/320ug)Atectura inhalation capsule (150/80ug)
What this trial is about
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.
Who can take part
Age range
12 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 μg) via Breezhaler, as per the approved label information
- 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 (For patients under the age of 18, consent and signature of a legal representative is required)
Exclusion criteria
- 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.
- Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
- Patients participating in other interventional clinical trials
Where it is running
18 locations listed.
- Novartis Investigative Site - Busan, South Korea
- Novartis Investigative Site - Gyeongsangnam Do, South Korea
- Novartis Investigative Site - Jeju City, South Korea
- Novartis Investigative Site - Jinju, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Taegu, South Korea
- Novartis Investigative Site - Ulsan, South Korea
- Novartis Investigative Site - Daegu, Dalseo gu, South Korea
- Novartis Investigative Site - Kangwon Do, Gangneung si, South Korea
- Novartis Investigative Site - Wŏnju, Gangwon-do, South Korea
- Novartis Investigative Site - Goyang-si, Gyeonggi-do, South Korea
- Novartis Investigative Site - Guri-si, Gyeonggi-do, South Korea
- Novartis Investigative Site - Jeonju, Jeollabuk-do, South Korea
- Novartis Investigative Site - Iksan Si, Jeonlabuk Do, South Korea
- Novartis Investigative Site - Daejeon, Korea, South Korea