Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma … (NCT00246922) | Clinical Trial Compass
CompletedPhase 3
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).
Japan150 participantsStarted 2004-12-01
Plain-language summary
The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.
Who can participate
Age range
20 Years – 71 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:
* Patients with asthma disease
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-05
Main exclusion criteria:
* % FEV1.0 \< 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
* Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
* Serious diseases
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 studied roflumilast over a long period — up to 52 weeks total — in Japanese patients specifically; does my ethnic background or personal health profile affect how relevant these results might be to me?
2Since this was a Phase 3 trial focused on long-term safety over 28 additional weeks, what safety concerns or side effects showed up during that extended period that I should know about before considering roflumilast?
3This trial has already been completed — does that mean roflumilast is now an approved or standard treatment option for asthma in my situation, or is it still considered experimental?
4Given that this study enrolled patients between 20 and 71 years old, how does my specific age and current asthma severity compare to the patients who were studied, and does that affect whether this treatment might be worth discussing for me?
5Before considering a medication like roflumilast that was tested in this long-term study, are there existing standard asthma treatments we should try first, and how would you weigh those options against what this trial found?
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
Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .