Progressive Idiopathic Pulmonary FibrosisPhase 4PROGRESSIONNCT03939520
Management of Progressive Disease in Idiopathic Pulmonary Fibrosis
A Phase 4 study testing pirfenidone and nintedanib and pirfenidone or nintedanib in people with Progressive Idiopathic Pulmonary Fibrosis, run by Hospices Civils de Lyon at 22 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Progressive Idiopathic Pulmonary Fibrosis
- What is being tested?
- pirfenidone and nintedanib and pirfenidone or nintedanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 22 sitesFrance
- Study dates
- 11 Jun 2020to 9 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CHU d'Angers
Angers
Centre Hospitalier de la côte Basque
Bayonne
CHRU de Besançon - Hôpital Jean Minjoz
Besançon
AP - HP - Hôpital Avicenne
Bobigny
CHRU Hôpital Cavale Blanche
Brest
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron
CHU de Caen - Hôpital de la Côte de Nacre
Caen
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon
CHRU de Lille - Hôpital Albert Calmette
Lille
CHU de Marseille - Hôpital Nord
Marseille
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier
CHU - Hôpital G.R. Laennec
Nantes
CHU de Nice, Hôpital Pasteur
Nice
APHP - Hôpital Xavier Bichat-Claude Bernard
Paris
Groupe Hospitalier Paris Saint Joseph
Paris
CHU Poitiers
Poitiers, 86021
Ch de Cornouaille
Quimper
CHU Rennes - Hôpital Pontchaillou
Rennes
CHU de Toulouse - Hôpital Larrey
Toulouse
CHRU, Tours - Hôpital Bretonneau
Tours
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy
Hôpital Robert Schuman
Vantoux
About this study
Official title: Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial
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.
Read more
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).
- Being tested
- pirfenidone and nintedanib, pirfenidone or nintedanib
- Keywords
- Pneumology, idiopathic pulmonary fibrosis, progressive disease, combined therapy, pirfenidone, nintedanib
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirfenidone and nintedanibDrug
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.
pirfenidone or nintedanibDrug
The second intervention 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).
pirfenidone or nintedanibDrug
The control group will keep on the same 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).
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy | Experimental | Not described Receives: Drug: pirfenidone and nintedanib |
| Switch monotherapy | Active comparator | Not described Receives: Drug: pirfenidone or nintedanib |
| Control group | Other | Not described Receives: Drug: pirfenidone or nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of the decline in the forced vital capacity (FVC) measured by spirometry
FVC will be measured by spirometry
Measured: 24 weeks
Secondary outcomes (16)
The proportion of patients who continue intent-to-treat therapy
Tolerance of antifibrotic therapy at week 24, at a minimal daily dose of two thirds of the full treatment dose (e.g. 200 mg/day of nintedanib and/or 1602 mg/day of pirfenidone), with temporary interruptions of no more than 28 consecutive days.
Measured: 24 weeks
Time to permanent study drug discontinuation
The interval from study treatment randomization to study drug permanent discontinuation or the end of follow-up. Study drug discontinuation will be considered in case of permanent termination of drug treatment allocated by randomization, transient discontinuation for longer than 28 consecutive days, or dose reduction below two thirds of the full treatment dose (i.e. 200 mg per day of nintedanib or 1602 mg per day or pirfenidone).
Measured: 24 weeks
Time to treatment failure
The time from study treatment randomization to the first occurrence during the 24 weeks follow-up of any of the following events:
- Death from any cause,
- Non-elective hospitalization from pulmonary cause (which is predefined by a set of criteria in protocol),
- Acute exacerbation of idiopathic pulmonary fibrosis (idiopathic or triggered),
- Decrease (based on relative decline) from baseline of ≥ 10% in FVC,
- Permanent study drug discontinuation (see above) (allcause). or the end of follow-up.
Measured: 24 weeks
Proportion of decrease ≥ 10% FVC relative decline or death
Proportion of patients with ≥ 10% FVC relative decline or death at week 24.
Measured: 24 weeks
Hospitalization-free survival
The time from randomization to the first occurrence during the 24 weeks follow-up of any of the following events:
- Death from any cause,
- All-cause unscheduled hospital admission, or the end of follow-up.
Measured: 24 weeks
Time from randomization to the first non-elective hospitalization from pulmonary cause
Non-elective hospitalization from pulmonary cause (which is predefined by a set of criteria in protocol) during the 24 weeks follow-up or the end of follow-up.
Measured: 24 weeks
Time from randomization to death
Time from randomization to death from any cause during the 24 weeks of the study or the end of follow-up.
Measured: 24 weeks
Progression of disease on imaging by computed tomography
Progression of disease evaluated by the change from baseline in volume of fibrotic features at imaging by computed tomography assessed at 24 weeks.
Measured: 24 weeks
Time from randomization to initiation of supplementary oxygen therapy
Time from randomization to initiation of supplementary oxygen therapy during the 24 weeks of the study or the end of follow-up.
Measured: 24 weeks
Time from randomization to acute exacerbation of idiopathic pulmonary fibrosis
Time from randomization to acute exacerbation of idiopathic pulmonary fibrosis (idiopathic or triggered) during the 24 weeks of the study or the end of follow-up.
Measured: 24 weeks
Quality of live assessed by the "Analogy and Likert" scale for the evaluation of dyspnea, cough and respiratory health
Absolute change in the "Analogy and Likert" scale relative to symptoms and impact on quality of life between baseline and week 24. The scale is between 3 and 11 points : 3 being the worst score and 11 being the best
Measured: 24 weeks
Quality of live assessed by the "Pulmonary Fibrosis (L-PF)" questionnaire
Absolute change in Living with the "Pulmonary Fibrosis (L-PF)" questionnaire relative to symptoms and impact on quality of life between baseline and week 24.
Measured: 24 weeks
Quality of live assessed by EuroQoL 5-dimension 5-level Questionnaire
Absolute change in EuroQoL 5-dimension 5-level (EQ-5D-5L) Questionnaire relative to symptoms and impact on quality of life between baseline and week 24. This questionnaire gives a score between 0 and 100 : 0 being the worst condition possible and 100 being the best.
Measured: 24 weeks
Quality of live assessed by King's Brief Interstitial Lung Disease Questionnaire
Absolute change in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) relative to symptoms and impact on quality of life between baseline and week 24. This questionnaire gives a score between 0 and 100 : 0 being the worst score and 100 being the best
Measured: 24 weeks
Link between CA-125 variations and disease progression, the endpoint will be the slope of the FVC (exploratory)
For the analysis of the link between CA-125 variations and disease progression, the endpoint will be the slope of the FVC measured during 24 weeks by hospital spirometry. The CA-125 variations between baseline and 12 weeks will be categorized in two categories: increased versus stable or decreased.
Measured: 24 weeks
Link between biomarkers variations and disease progression, the endpoint will be the slope of the FVC (exploratory)
For the analysis of the link between biomarkers variations and disease progression, the endpoint will be the slope of the FVC measured during 24 weeks by hospital spirometry. The biomarkers variations between baseline and 12 weeks will be categorized in two categories: increased versus stable or decreased. (Ancillary study)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start11 Jun 2020
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent COTTIN, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939520
- Sponsor's protocol ID
- 69HCL19_0029
- Other IDs
- 2024-511427-34-00, 2019-004326-19, 2019
- Acronym
- PROGRESSION
- Status last verified
- Jan 2026
- First submitted
- 3 May 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03939520
- Acronym / sponsor ID
- PROGRESSION / 69HCL19_0029
- Keywords
- Pneumology, idiopathic pulmonary fibrosis, progressive disease, combined therapy, pirfenidone, nintedanib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined therapy | Experimental | Drug: pirfenidone and nintedanib |
| Switch monotherapy | Active comparator | Drug: pirfenidone or nintedanib |
| Control group | Other | Drug: pirfenidone or nintedanib |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
- Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pirfenidone and nintedanibThe 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. | Drug | Combined therapy |
| pirfenidone or nintedanibThe second intervention 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). | Drug | Switch monotherapy |
| pirfenidone or nintedanibThe control group will keep on the same 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). | Drug | Control group |
Primary outcome
Slope of the decline in the forced vital capacity (FVC) measured by spirometry
Time frame: 24 weeks
FVC will be measured by spirometry
16 secondary outcomes
The proportion of patients who continue intent-to-treat therapy
Time frame: 24 weeks
Time to permanent study drug discontinuation
Time frame: 24 weeks
Time to treatment failure
Time frame: 24 weeks
Proportion of decrease ≥ 10% FVC relative decline or death
Time frame: 24 weeks
Hospitalization-free survival
Time frame: 24 weeks
Time from randomization to the first non-elective hospitalization from pulmonary cause
Time frame: 24 weeks
Time from randomization to death
Time frame: 24 weeks
Progression of disease on imaging by computed tomography
Time frame: 24 weeks
Time from randomization to initiation of supplementary oxygen therapy
Time frame: 24 weeks
Time from randomization to acute exacerbation of idiopathic pulmonary fibrosis
Time frame: 24 weeks
Quality of live assessed by the "Analogy and Likert" scale for the evaluation of dyspnea, cough and respiratory health
Time frame: 24 weeks
Quality of live assessed by the "Pulmonary Fibrosis (L-PF)" questionnaire
Time frame: 24 weeks
Quality of live assessed by EuroQoL 5-dimension 5-level Questionnaire
Time frame: 24 weeks
Quality of live assessed by King's Brief Interstitial Lung Disease Questionnaire
Time frame: 24 weeks
Link between CA-125 variations and disease progression, the endpoint will be the slope of the FVC (exploratory)
Time frame: 24 weeks
Link between biomarkers variations and disease progression, the endpoint will be the slope of the FVC (exploratory)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent COTTIN, Pr principal investigator
Hospices Civils de Lyon
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pirfenidone and nintedanib and pirfenidone or nintedanib in people with Progressive Idiopathic Pulmonary Fibrosis, run by Hospices Civils de Lyon at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of the decline in the forced vital capacity (FVC) measured by spirometry (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.