Management of Progressive Disease in Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT03939520|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Idiopathic pulmonary fibrosis (IPF) is a prototype of chronic, progressive, and fibrotic lung disease. It has been considered rare, with an incidence estimated to 11.5 cases per 100 000 individuals per year. Increasing rates of hospital admissions and deaths due to IPF suggest an increasing burden of disease. The median survival time from diagnosis is 2-4 years.
Recently two disease-modifying therapies, pirfenidone and nintedanib, have been approved worldwide. Both drugs reduce the disease progression as measured by progressive decline in forced vital capacity (FVC), with a reduction of overall mortality showed by meta-analysis of phase III pirfenidone trials.
However, progression of disease continues to occur despite the currently available drug therapy. Many patients die from progressive, chronic hypoxemic respiratory failure, or less frequently from acute exacerbation of pulmonary fibrosis. In these patients, no data are available to guide management between continuation of the prescribed antifibrotic drug, to switch to the other available antifibrotic drug, or to combine the available drugs.
The combination of nintedanib and pirfenidone is not recommended outside clinical trials. However, although both antifibrotic drugs were developed and approved as monotherapy, two recent trials have suggested the feasibility and safety of combining them over a 12-24 weeks period. These results encourage further studies of combination treatment with pirfenidone and nintedanib in patients with IPF. Such study is timely, as there is a risk that clinicians facing the continued worsening of disease in patients receiving one of the available drugs may prescribe both drugs combined outside clinical trials, potentially exposing patients to a currently unknown risk.
This study will evaluate the efficacy and tolerance of the combination pirfenidone and nintedanib as compared to a "switch monotherapy": i.e. switching from the current to the other of the two existing drugs prescribed as monotherapy, in patients who present chronic worsening IPF despite receiving either pirfenidone or nintedanib.
|Condition or disease||Intervention/treatment||Phase|
|Progressive Idiopathic Pulmonary Fibrosis||Drug: pirfenidone and nintedanib Drug: pirfenidone or nintedanib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
|Experimental: Combined therapy||
Drug: pirfenidone and nintedanib
The experimental group will receive pirfenidone 2403 mg per day (at least 1602 mg) in combination with nintedanib 300 mg per day (at least 200 mg) during 24 weeks.
|Active Comparator: Switch monotherapy||
Drug: pirfenidone or nintedanib
The control group will switch from one monotherapy during 24 weeks: with pirfenidone 2403 mg per day (at least 1602 mg) or nintedanib 300 mg per day (at least 200 mg) to the other monotherapy (nintedanib in patients who received pirfenidone as first line therapy before inclusion and conversely).
- Slope of the decline in the forced vital capacity (FVC) measured by spirometry [ Time Frame: 24 weeks ]
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): NCT03939520
|Contact: Vincent COTTIN, Pr||4 27 85 77 00 ext +firstname.lastname@example.org|
|Contact: Géraldine SAMSON||4 27 85 53 26 ext +email@example.com|
|Hôpital Pneumologique et Cardiovasculaire Louis Pradel|
|Contact: Vincent Cottin, Pr firstname.lastname@example.org|
|Principal Investigator:||Vincent COTTIN, Pr||Hospices Civils de Lyon|