IPF patients: is combining two drugs better than switching?
NCT ID NCT03939520
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 279 adults with worsening idiopathic pulmonary fibrosis (IPF), a serious lung disease. It compared taking two antifibrotic drugs together (pirfenidone and nintedanib) versus switching to the other single drug. The goal was to see which approach better slows lung decline and is safer. Results help guide treatment decisions for patients whose disease progresses despite current therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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279 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient aged ≥ 50 years. * Patient with Idiopathic Pulmonary Fibrosis satisfying the ATS/ERS/JRS/ALAT diagnostic criteria (29) diagnosed. In the absence of a surgical lung biopsy, high-resolution computed tomography (HRCT) must be "consistent with Usual Interstitial Pneumonia (UIP)" defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below: A. Definite honeycomb lung destruction with basal and peripheral predominance. B. Presence of reticular abnormality and traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance. C. Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern. * \- Patient who fulfill at least 1 of the 4 criteria for IPF progression in the 12 months (+/- one six months) before screening, despite antifibrotic treatment in clinical practice (if yes check the option(s)). These criteria are: 0 Relative decline in FVC ≥10% predicted 0 Relative decline in FVC ≥5-\<10% predicted and worsened respiratory symptoms 0 Relative decline in FVC ≥5-\<10% predicted and increased extent of fibrotic changes on chest imaging 0 Worsened respiratory symptoms and increased extent of fibrotic changes on chest imaging * Patient must have been on a stable dose of pirfenidone or nintedanib prescribed as first-line therapy for at least 6 months, with good tolerance of 1602 to 2403 mg per day of pirfenidone or 200 to 300 mg per day of nintedanib. * Patient who has a FVC ≥ 45% of predicted. * Patient who has a forced expiratory volume in 1 second (FEV1)/FVC ratio \> 0.70. * Patient who has a life expectancy of at least 9 months. * Patient who has provided his written informed consent to participate in the study. * Patient affiliated to a social insurance regimen. Exclusion Criteria: * Patients under judicial protection. * Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if \> 55 years) and who did not agree to use highly effective methods of birth control throughout the study. * Patient who is currently on both pirfenidone and nintedanib. * Patient who has already received pirfenidone and nintedanib either concomitantly or successively. * Patient who has a contra-indication to pirfenidone or nintedanib. * Patient who has emphysema \> 15% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT. * Patient who had acute exacerbation of idiopathic pulmonary fibrosis within the previous 3 months. * Patient who has a history of cigarette smoking within the previous 3 months. * Patient who has received experimental therapy for IPF within 4 weeks before baseline. * Patient who is receiving systemic corticosteroids equivalent to prednisone \> 15 mg/day or equivalent within 2 weeks before baseline. * Patient who received Immuno-suppressants (e.g. methotrexate, azathioprine, cyclophosphamide, cyclosporine, sirolimus, everolimus or other immunosuppressants) within 4 weeks before baseline. * Patient who has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment. * Patient who, in the Investigator's opinion, is not able to perform home spirometry in accordance with the protocol. * Patient who has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study. * Patient who has baseline resting oxygen saturation of \< 88% on room air or supplemental oxygen. * Patient who had lung transplantation or who is on a lung transplant list and the investigator anticipates the patient will not be able to complete the study prior to transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AP - HP - Hôpital Avicenne
Bobigny, France
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APHP - Hôpital Xavier Bichat-Claude Bernard
Paris, France
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CHRU Hôpital Cavale Blanche
Brest, France
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CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
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CHRU de Lille - Hôpital Albert Calmette
Lille, France
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CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
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CHRU, Tours - Hôpital Bretonneau
Tours, France
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CHU - Hôpital G.R. Laennec
Nantes, France
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CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, France
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CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, France
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CHU Poitiers
Poitiers, 86021, France
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CHU Rennes - Hôpital Pontchaillou
Rennes, France
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CHU d'Angers
Angers, France
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CHU de Caen - Hôpital de la Côte de Nacre
Caen, France
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CHU de Marseille - Hôpital Nord
Marseille, France
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CHU de Nice, Hôpital Pasteur
Nice, France
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CHU de Toulouse - Hôpital Larrey
Toulouse, France
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Centre Hospitalier de la côte Basque
Bayonne, France
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Ch de Cornouaille
Quimper, France
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Groupe Hospitalier Paris Saint Joseph
Paris, France
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Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, France
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Hôpital Robert Schuman
Vantoux, France