Effect of add-on Doxofylline on Lung Function in Stable COPD (NCT04238221) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of add-on Doxofylline on Lung Function in Stable COPD
Italy78 participantsStarted 2026-12-01
Plain-language summary
It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.
Who can participate
Age range
40 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:
* COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines
* baseline FEV1 ≤ 80% of predicted value
* active or former smokers with smoking history ≥ 10 pack-years
* patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS)
* clinically stable disease for 6 months.
Exclusion Criteria:
* previous or current diagnosis of bronchial asthma
* previous lung volume reduction through surgery or endobronchial valves
* inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test
* known allergy or intolerance to doxofylline
* current or potential pregnancy
* mini-Mental test \<21
* congestive heart failure NYHA III or IV
* recent (\<6 months) myocardial infarction
* unstable arrhythmias
* chronic hypotension
* active peptic ulcer
* severe liver disease
* active neoplasia
* history of drug or alcohol abuse.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Difference in changes in FEV1 after 4 weeks of treatment