Management of Progressive Disease in Idiopathic Pulmonary Fibrosis (PROGRESSION)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    378
  • sponsor
    Hospices Civils de Lyon
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Updated on 24 March 2022
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Summary

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 and as to a "control group": i.e.treatment still be on as before randomization (pirfenidone or nintedanib).

Details
Condition Progressive Idiopathic Pulmonary Fibrosis
Treatment pirfenidone and nintedanib, pirfenidone or nintedanib
Clinical Study IdentifierNCT03939520
SponsorHospices Civils de Lyon
Last Modified on24 March 2022

Eligibility

 Yes No Not Sure

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
Patients with diagnosis of IPF who fulfill one of the two following criteria for
progressive disease within 12 months (+/- six months) of the screening visit as
assessed by the investigator will be eligible
worsening of respiratory symptoms AND clinically significant decline in FVC %
predicted (%pred) based on ≥10% relative decline
Patient who has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70
Worsening of respiratory symptoms AND marginal decline in FVC %predicted based on ≥5 -
Patient who has a life expectancy of at least 9 months
<10% relative decline in FVC, AND with increasing extent of fibrotic changes on chest
Patient who has provided his written informed consent to participate in the study
imaging
Patient affiliated to a social insurance regimen
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 ≥ 50% and ≤ 90% of predicted
Patient who has an Hemoglobin (Hb) corrected and/or Hb uncorrected Diffusing capacity
of the Lung for carbon monoxide (DLCO) ≥ 30% and ≤ 80% of predicted

Exclusion Criteria

Patients under judicial protection
Patient who is currently on both pirfenidone and nintedanib
Patient who has a contra-indication to pirfenidone or nintedanib
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
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 has already received pirfenidone and nintedanib either concomitantly or
successively
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 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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