Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-… (NCT00242307) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).
Japan450 participantsStarted 2004-05-01
Plain-language summary
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Who can participate
Age range
20 Years – 70 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.
Main inclusion criteria:
* Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
* No change in asthma treatment during the last 4 weeks prior to the registration
* Non-smokers or ex-smokers for 12 months or more
* %FEV1 ranging between 60 and 80%
Main exclusion criteria:
* Patients with poorly controlled asthma
* Inhalation therapy exceeding low dose during 4 weeks prior to the registration
* Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation
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 trial tested a drug called roflumilast specifically in Japanese patients with bronchial asthma — does my ethnic background or the population this was studied in affect how relevant these results might be for me?
2Since this was a combined Phase 2 and Phase 3 trial, what do the results tell us about how well roflumilast actually worked and whether it was safe, and is that evidence strong enough to guide my treatment decisions?
3The trial measured changes in lung function — do the improvements found in lung function measurements actually translate into real-world benefits I'd notice, like fewer asthma attacks or better day-to-day breathing?
4How does roflumilast compare to the asthma medications I'm currently on or might start with, and would my doctor consider it a better, worse, or complementary option based on what this trial found?
5This trial is now completed — is roflumilast approved or available for asthma patients like me, or would participating in a study still be the only way to access it?
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.