Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis (NCT02460588) | Clinical Trial Compass
CompletedPhase 3
Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis
France120 participantsStarted 2015-12
Plain-language summary
Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.
Who can participate
Age range
18 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 :
* ≥18 years of age
* Definite or probable IPF diagnosis defined on 2011 international recommendations
* Definite or suspicion of AE defined by IPFnet criteria after exclusion of alternative diagnosis of acute worsening.
* Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
* Affiliation to the social security
* Able to understand and sign a written informed consent form
Exclusion Criteria:
* Identified etiology for acute worsening (i.e. infectious disease)
* Known hypersensitivity or contra-indication to CYC or to any component of the study treatment
* Patient on mechanical ventilation
* Active bacterial, viral, fungal or parasitic infection
* Active cancer
* Patient on a lung transplantation waiting list
* Treatment with CYC in the last 12 months
* Patient participating to another clinical trial
* Pregnancy or lactation
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.