European Trial of Pirfenidone in BOS, A European Multi-center Study (EPOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02262299|
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : January 18, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
A European multi-centre, randomised, double-blind placebo-controlled trial of Pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients.
Randomized double blinded, placebo controlled study. Eligible patients are to be randomized in a 1:1 ratio to receive either Pirfenidone 2403 mg/d or the matching placebo treatment for 6 months.
Primary objective To evaluate the effect of Pirfenidone on the change in FEV1 in liters over 6 months in lung transplant recipients with bronchiolitis obliterans syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Disorder Related to Lung Transplantation CLAD, Bronchiolitis Obliterans||Drug: Pirfenidone Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A European Multi-center, Randomised, Double-blind Trial of Pirfenidone in Bronchiolitis-obliterans-syndrome Grade 1-3 in Lung Transplant Recipients|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
Placebo Comparator: Placebo
Receive placebo tablets
Recieve tablets with placebo
Active Comparator: Pirfenidone
Upon enrollment, subjects will be randomized to either the treatment group (Pirfenidone) or to the placebo group (1:1 ratio). The trial medication will be administered as 267-mg oral capsules and titrated to a maintenance dose of 2403 mg/d (3 capsules TID, for a total of 9 capsules/day).
Receive tablets with pirfenidone
Other Name: Esbriet
- To evaluate the effect of Pirfenidone on the change in FEV1 in liters over 6 months in lung transplant recipients with bronchiolitis obliterans syndrome. [ Time Frame: 6 months ]
- - Categorical percentage change in FEV1 [ Time Frame: 6 months ]
- - Change in Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
- - Change in Total Lung Capacity (TLC) [ Time Frame: 6 months ]
- - Change in FEV1/FVC ratio [ Time Frame: 6 months ]
- - Number of patients with treatment failure [ Time Frame: 6 months ]
- - Change in BOS grade [ Time Frame: 6 months ]
- - Change in percent predicted diffusion capacity (DLCO) [ Time Frame: 6 months ]
- - Change in functional level as assessed by the 6MWT [ Time Frame: 6 months ]
- - Hospital admission for any reason [ Time Frame: 6 months ]
- - Death or re-transplantation rates [ Time Frame: 6 months ]
- - Change in QoL as assessed by EQ5D [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients >18 years of age
- Azithromycin therapy for at least 4 weeks prior to study start, with an Azithromycin dose of minimum 250 mg/day at least 3 times per week as this is considered standard therapy for bronchiolitis obliterans syndrome.
- Double lung transplantation is required.
- Patients must be at least 6 months after transplantation and must have documented post-transplant baseline value of FEV1 (mean of the 2 highest values measured at least 3 weeks apart according to ISHLT criteria).
- Patients must have BOS grade 1 to BOS grade 3.
- Patients must have documented progressive disease as demonstrated by all of the following criteria:
- Patients must have at least 3 FEV1-measurements in the last 6 months, each at least 3 weeks apart
- a total decline of at least 200ml in FEV1 i
- a decline of at least 50 ml in the last two measurements
- Patients with lung redo transplantation, combined transplantation (including heart and lung transplantation) or single lung recipients.
- Patients with any severe comorbidity complicating BOS which might determine the prognosis and functional level of the patient (e.g. invasive aspergillosis, active malignant disease) within the last 12 months.
- FEV1 decline related to other non BOS causes (eg pneumothorax, bronchial stenosis, effusion, etc.)
- Patients who have developed BOS grade 3.
- Patients who on Thorax CT at entry demonstrate new significant findings which are not compatible with BOS like interstitial fibrosis, consolidation, appearances suggesting Restrictive Allograft Syndrome (RAS) and acute pulmonary infection as cause of decline in lung function.
- Documented acute perivascular rejection higher than grade A1 or findings compatible with antibody mediated rejection
- Pregnancy or lactation (women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study).
- Renal insufficiency (Creatinine clearance <30 ml/min calculated by the CKD-Epi formula.
- Any of the following liver test criteria above the specified limit:
- Total bilirubin above the upper limit of the normal range (ULN), except in patients with predominantly unconjugated hyperbilirubinemia (e.g., Gilbert's syndrome)
- Aspartate or alanine aminotransferase (AST or ALT) >3 × ULN
- Known allergy or hypersensitivity to Pirfenidone
- Ongoing use or expected use of any of the following therapies:
- Strong inhibitors of CYP1A2 (e.g. fluvoxamine or enoxacin)
- Moderate inhibitors of CYP1A2 (e.g. mexiletine, thiabendazole, or phenylpropanolamine [Note: ciprofloxacin will be allowed only at doses ≤500 mg BID])
- Previous treatment with Pirfenidone after transplantation
- Patients who have resumed smoking after transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262299
|University Hospital Gasthuisberg, Katholike Universiteit Leuven|
|Leuven, Belgium, 300|
|Rigshospitalet, Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|University Hospital Essen, Department of Pneumonology|
|Essen, Germany, 45239|
|Medizinische Hochschule Hannover, Klinik für Pneumonologie|
|Hannover, Germany, 30625|
|Klinikum Grosshadern, Division of Pulmonary Diseases|
|Munich, Germany, 81377|
|Groningen University Medical Center, Lung Transplant Team|
|Groningen, Netherlands, 9700|
|Rikshospitalet, National University Hospital|
|Oslo, Norway, 0424|
|Sahlgrenska University Hospital, Department of respiratory diseases|
|Gothenburg, Sweden, 41345|
|Newcastle, United Kingdom, NE7 7DN|
|Principal Investigator:||Michael Perch, MD||Rigshospitalet, Denmark|
|Responsible Party:||Michael Perch, Medical Director Danish National Lung Transplant Program, Rigshospitalet, Denmark|
|Other Study ID Numbers:||
|First Posted:||October 13, 2014 Key Record Dates|
|Last Update Posted:||January 18, 2020|
|Last Verified:||January 2020|
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal