A 24-week rPMS Study in Real-world Setting for Enerzair (NCT05274425) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A 24-week rPMS Study in Real-world Setting for Enerzair
South Korea683 participantsStarted 2022-05-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused mainly on tracking side effects and unexpected adverse events from Enerzair over 24 weeks — does that mean we'd primarily be contributing safety data rather than testing whether the treatment works better than what I'm already on?
2Since this trial is listed as 'active, not recruiting,' does that mean I can no longer join it, and if so, are there similar real-world studies of Enerzair that are still open to new participants?
3The study measures 'unexpected' adverse events specifically — does that suggest there are still unknowns about how Enerzair behaves in everyday patients outside of controlled settings, and how does that compare to what's already known from its earlier clinical trials?
4How does Enerzair compare to the asthma medications I'm currently on or might be offered as standard care, and would enrolling in a study like this be the right path for me at this stage of my diagnosis?
5This is a 24-week commitment in a real-world setting — what would that actually involve for me in terms of visits, monitoring, or reporting requirements, and is that something my situation could realistically accommodate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events and serious adverse events
Timeframe: 24 weeks
2
Incidence of unexpected adverse events and unexpected serious adverse events