Interstitial Lung DiseasePhase 2NCT02958917
Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
A Phase 2 study testing Pirfenidone in people with Interstitial Lung Disease, run by Evans Fernandez Perez at 1 site in United States.
Trial summary
Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 2 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multidisciplinary consensus diagnosis of FHP, defined from the first instance in which a patient was informed of having FHP for at least 3 to 6 months.
- Age 18 through 80 years at randomization.
- Diagnosis of typical or compatible FHP by HRCT according to pre-specified criteria (Note: HRCT scan performed within 6 months of the start of screening may be used if it meets image acquisition guidelines):
- Typical FHP: Evidence of lung fibrosis (reticular abnormality and/or, traction bronchiectasis and/or, architectural distortion, and/or honeycombing) with either of the following: i. Profuse poorly defined centrilobular nodules of ground-glass opacity affecting all lung zones.
- Inspiratory mosaic attenuation with the three-density sign. AND iii. Lack of features suggesting an alternative diagnosis.
- Compatible FHP: Evidence of lung fibrosis (as above) with any of the following: i. Patchy or diffuse ground-glass opacity. ii. Patchy, non-profuse centrilobular nodules of ground-glass attenuation iii. Mosaic attenuation and lobular air-trapping that do not meet the criteria for typical fibrotic HP.
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- AND iv. Lack of features suggesting an alternative diagnosis.
- Indeterminate FHP: CT signs of fibrosis without other features suggestive of HP and lack of features suggesting an alternative diagnosis. These patients are required to have a known antigen exposure and BAL lymphocytosis (≥20%) or transbronchial biopsies demonstrating non-necrotizing granuloma(s) or lymphocytosis, or surgical lung histology consistent with HP.
- FHP Disease Severity and Progression
- FVC ≥40%, DLCO ≥30% based either on historical pulmonary function tests obtained in the 30 days prior to screening or on tests obtained during screening
- In the investigator's opinion, evidence of disease progression: worsening respiratory symptoms and an increased in the extent of fibrosis on HRCT or relative decline in the FVC% of at least 5%.
- Able to walk ≥100 m during the 6-minute walk test (6MWT) at Screening.
- Informed Consent and Protocol Adherence
- Able to understand and sign a written informed consent form.
- Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
Who cannot join
- Disease-Related Exclusions
- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
- Cigarette smoking at Screening or unwilling to avoid tobacco products throughout the study
- Known explanation for the interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, pneumoconiosis.
- Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, and rheumatoid arthritis.
- Expected to receive a lung transplant within 6 to12 months from randomization or on a lung transplant waiting list at randomization.
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- Medical Exclusions
- Any condition other than FHP that, in the opinion of the investigator, is likely to result in the death of the patient within 6 to12 months.
- Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone.
- 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. If abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide).
- History of ongoing alcohol or substance abuse.
- History of severe hepatic impairment or end-stage liver disease.
- History of end-stage renal disease requiring dialysis.
- Clinical evidence of active infection including, but not limited to, bronchitis, pneumonia, sinusitis, or urinary tract infection.
- Unstable or deteriorating cardiac disease, including but not limited to the following:
- Unstable angina pectoris or myocardial infarction.
- Congestive heart failure requiring hospitalization.
- Uncontrolled clinically significant arrhythmias.
- Laboratory Exclusions
- Any of the following liver function test criteria above specified limits: total bilirubin > 2.0 mg/dL, excluding patients with Gilbert's syndrome; aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >3 ULN; alkaline phosphatase >2.5 ULN within past 30 days.
- Creatinine clearance <30 mL/min, calculated using the Cockcroft-Gault formula within the past 30 days.
- Electrocardiogram with a QTc interval >500 msec at Screening.
- Medication Exclusions
- Prior use of pirfenidone, nintadinib or known hypersensitivity to any of the components of study treatment.
- Introduction, increase or escalation of immunosuppressive pharmacological therapy within 1 month (e.g., prednisone, azathioprine, mycophenolic acid and mycophenolate mofetil).
- Use of any of the following therapies within 28 days before Screening:
- Bosentan, ambrisentan, cyclophosphamide, cyclosporine, etanercept, iloprost, infliximab, methotrexate, tacrolimus, tetrathiomolybdate, TNF-α inhibitors, imatinib mesylate, Interferon gamma-1b, and tyrosine kinase inhibitors.
- Fluvoxamine.
- Sildenafil (daily use). Note: intermittent use for erectile dysfunction is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. These antigens can be substances such as molds, chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into the bloodstream to reach other organs.
Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your condition. The use of pirfenidone has not been approved for the treatment of FHP. It is considered experimental treatment in this study.
Read the detailed description
The purpose of this study is to evaluate the potential benefits and the safety of treatment with pirfenidone compared to placebo in subjects with FHP.
STUDY SUMMARY This study will include about 42 subjects at National Jewish Health. This is a "double-blind study" which means neither the subject nor the study staff will know if the subject is getting pirfenidone or placebo during the study. This is done to be sure that no one knows who is getting pirfenidone or placebo and the effects of the treatment can be measured objectively, without bias. Subject's that enroll in this study will have an equal chance of getting pirfenidone or placebo. The decision about which treatment the subject will receive (randomization) is made through a central organization.
Subjects in the study will receive either pirfenidone (2403 mg every day) or placebo capsules (a safe, inactive substance that will look the same as the pirfenidone capsules). Both the placebo and pirfenidone will be supplied in opaque, hard, white gelatin capsules and will be taken as 3 capsules by mouth, 3 times a day (a total of 9 capsules per day) and should be taken with food.
Subjects who participate in this study will be asked to take the capsules as prescribed every day for 52 weeks (12 months).
- Conditions
- Interstitial Lung Disease
- Being tested
- Pirfenidone, Placebo controlled
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
This is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 42-45 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks.
Placebo controlledOther
Also called Placebo
This is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 42-45 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| pirfenidone 2403 mg/d | Placebo comparator | Subjects will be randomized in a 2:1 ratio to receive either pirfenidone 2403 mg/d or a placebo equivalent. Receives: Drug: Pirfenidone; Other: Placebo controlled |
| Placebo | Active comparator | The placebo will be visually similar to pirfenidone. Receives: Drug: Pirfenidone; Other: Placebo controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 52 in Percent Predicted FVC.
The primary efficacy analysis will estimate the mean rank change in percent predicted FVC from Baseline to Week 52. Data will be analyzed using a rank linear regression model with the rank change in percent predicted FVC from Baseline to Week 52 as the outcome variable and rank Baseline percent predicted FVC and HP therapy (placebo or pirfenidone) and concomitant immunosuppressive therapy as covariates. The treatment effect will be tested using the Wald test.
The primary efficacy analysis will be tested at an alpha level of 0.05. Missing data due to reasons other than death will be replaced with imputed values using the MICE method (multiple imputations via chained equation).
Subjects with missing assessments due to death will be ranked worse than those who remain alive. Subjects who die will be ranked according to the time until death, with the shortest time until death as the worst rank.
Measured: Up to 52 weeks.
Secondary outcomes (6)
Number of Participants With Progression-free Survival (PFS) Defined as the Time From Study Treatment Randomization to the First Occurrence of Any of the Following Events:
- Relative decline from baseline in ≥10% in FVC and/or DLCO b. Acute exacerbation of FHP defined as acute respiratory declined leading to hospitalization or ER or Urgent care evaluation; or evidence of all of the following criteria within a 4-week period in the outpatient setting: i. Increase from baseline FIO2 ≥1 L O2. ii. Clinically significant worsening of dyspnea and/or cough. iii. New, superimposed ground-glass opacities or consolidation or new alveolar opacities on chest x-ray or CT.
- A decrease from baseline of at least 50 meters in 6mw distance. d. Change in background therapy (need for a new course of PO or IV steroids or for the patient receiving maintenance prednisone, as a need to increase the dose by 10 mg or more; and/or addition of cyclophosphamide, azathioprine, mycophenolate mofetil, or mycophenolic acid).
- Death
Measured: Up to 52 weeks.
Slope of FVC Over Treatment Period.
The slope for the annual rate of FVC decline
Measured: Up to 52 weeks.
Mean Change in Percent Predicted DLCO
Mean change in percent predicted diffusing capacity for carbon monoxide (DLCO) from baseline to week 52
Measured: Up to 52 weeks.
Number of Participants With All-cause Hospitalization
Proportion of patients with all-cause hospitalization
Measured: Up to 52 weeks.
Number of Participant With Hospitalization for a Respiratory Cause
The proportion of patients with hospitalization for a respiratory cause
Measured: Up to 52 weeks.
Visual Extent in the Percentage of Lung CT Fibrosis
Mean change from baseline to week 52 in the visual extent of the percentage of lung CT fibrosis.
Measured: Up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start5 Jun 2017
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Why it stopped: covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evans Fernandez Perez
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Evans Fernandez Perez, National Jewish Health
- Investigators
- Evans Fernández, MD, MS, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958917
- Sponsor's protocol ID
- HS-3034
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2016
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swigris JJ, Aronson K, Fernandez Perez ER. A first look at the reliability, validity and responsiveness of L-PF-35 dyspnea domain scores in fibrotic hypersensitivity pneumonitis. BMC Pulm Med. 2024 Apr 19;24(1):188. doi: 10.1186/s12890-024-02991-1.
PubMed 38641768Fernandez Perez ER, Crooks JL, Lynch DA, Humphries SM, Koelsch TL, Swigris JJ, Solomon JJ, Mohning MP, Groshong SD, Fier K. Pirfenidone in fibrotic hypersensitivity pneumonitis: a double-blind, randomised clinical trial of efficacy and safety. Thorax. 2023 Nov;78(11):1097-1104. doi: 10.1136/thorax-2022-219795. Epub 2023 Apr 7.
PubMed 37028940Fernandez Perez ER, Crooks JL, Swigris JJ, Solomon JJ, Mohning MP, Huie TJ, Koslow M, Lynch DA, Groshong SD, Fier K. Design and rationale of a randomised, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis. ERJ Open Res. 2021 Jun 7;7(2):00054-2021. doi: 10.1183/23120541.00054-2021. eCollection 2021 Apr.
PubMed 34109243
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT02958917
- Acronym / sponsor ID
- HS-3034
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: covid-19 pandemic
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Evans Fernandez PerezUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. These antigens can be substances such as molds, chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into the bloodstream to reach other organs.
Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your condition. The use of pirfenidone has not been approved for the treatment of FHP. It is considered experimental treatment in this study.
Detailed description
The purpose of this study is to evaluate the potential benefits and the safety of treatment with pirfenidone compared to placebo in subjects with FHP.
STUDY SUMMARY This study will include about 42 subjects at National Jewish Health. This is a "double-blind study" which means neither the subject nor the study staff will know if the subject is getting pirfenidone or placebo during the study. This is done to be sure that no one knows who is getting pirfenidone or placebo and the effects of the treatment can be measured objectively, without bias. Subject's that enroll in this study will have an equal chance of getting pirfenidone or placebo. The decision about which treatment the subject will receive (randomization) is made through a central organization.
Subjects in the study will receive either pirfenidone (2403 mg every day) or placebo capsules (a safe, inactive substance that will look the same as the pirfenidone capsules). Both the placebo and pirfenidone will be supplied in opaque, hard, white gelatin capsules and will be taken as 3 capsules by mouth, 3 times a day (a total of 9 capsules per day) and should be taken with food.
Subjects who participate in this study will be asked to take the capsules as prescribed every day for 52 weeks (12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pirfenidone 2403 mg/d | Placebo comparator | Drug: Pirfenidone, Other: Placebo controlledSubjects will be randomized in a 2:1 ratio to receive either pirfenidone 2403 mg/d or a placebo equivalent. |
| Placebo | Active comparator | Drug: Pirfenidone, Other: Placebo controlledThe placebo will be visually similar to pirfenidone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Multidisciplinary consensus diagnosis of FHP, defined from the first instance in which a patient was informed of having FHP for at least 3 to 6 months.
- Age 18 through 80 years at randomization.
- Diagnosis of typical or compatible FHP by HRCT according to pre-specified criteria (Note: HRCT scan performed within 6 months of the start of screening may be used if it meets image acquisition guidelines):
- AND iv. Lack of features suggesting an alternative diagnosis.
- FHP Disease Severity and Progression
Key exclusion criteria (29 listed)
- Disease-Related Exclusions
- Medical Exclusions
- Laboratory Exclusions
- Medication Exclusions
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 |
|---|---|---|
| PirfenidoneThis is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 42-45 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks. | Drug | Placebo, pirfenidone 2403 mg/d |
| Placebo controlledAlso: PlaceboThis is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 42-45 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks. | Other | Placebo, pirfenidone 2403 mg/d |
Primary outcome
Mean Change From Baseline to Week 52 in Percent Predicted FVC.
Time frame: Up to 52 weeks.
The primary efficacy analysis will estimate the mean rank change in percent predicted FVC from Baseline to Week 52. Data will be analyzed using a rank linear regression model with the rank change in percent predicted FVC from Baseline to Week 52 as the outcome variable and rank Baseline percent predicted FVC and HP therapy (placebo or pirfenidone) and concomitant immunosuppressive therapy as covariates. The treatment effect will be tested using the Wald test. The primary efficacy analysis will be tested at an alpha level of 0.05. Missing data due to reasons other than death will be replaced with imputed values using the MICE method (multiple imputations via chained equation). Subjects with missing assessments due to death will be ranked worse than those who remain alive. Subjects who die will be ranked according to the time until death, with the shortest time until death as the worst rank.
6 secondary outcomes
Number of Participants With Progression-free Survival (PFS) Defined as the Time From Study Treatment Randomization to the First Occurrence of Any of the Following Events:
Time frame: Up to 52 weeks.
Slope of FVC Over Treatment Period.
Time frame: Up to 52 weeks.
Mean Change in Percent Predicted DLCO
Time frame: Up to 52 weeks.
Number of Participants With All-cause Hospitalization
Time frame: Up to 52 weeks.
Number of Participant With Hospitalization for a Respiratory Cause
Time frame: Up to 52 weeks.
Visual Extent in the Percentage of Lung CT Fibrosis
Time frame: Up to 52 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38641768Swigris JJ, Aronson K, Fernandez Perez ER. A first look at the reliability, validity and responsiveness of L-PF-35 dyspnea domain scores in fibrotic hypersensitivity pneumonitis. BMC Pulm Med. 2024 Apr 19;24(1):188. doi: 10.1186/s12890-024-02991-1.
- Derived from this study: PubMed 37028940Fernandez Perez ER, Crooks JL, Lynch DA, Humphries SM, Koelsch TL, Swigris JJ, Solomon JJ, Mohning MP, Groshong SD, Fier K. Pirfenidone in fibrotic hypersensitivity pneumonitis: a double-blind, randomised clinical trial of efficacy and safety. Thorax. 2023 Nov;78(11):1097-1104. doi: 10.1136/thorax-2022-219795. Epub 2023 Apr 7.
- Derived from this study: PubMed 34109243Fernandez Perez ER, Crooks JL, Swigris JJ, Solomon JJ, Mohning MP, Huie TJ, Koslow M, Lynch DA, Groshong SD, Fier K. Design and rationale of a randomised, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis. ERJ Open Res. 2021 Jun 7;7(2):00054-2021. doi: 10.1183/23120541.00054-2021. eCollection 2021 Apr.
- Individual participant dataSharing planned: No
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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.
Evans Fernández, MD, MS principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in people with Interstitial Lung Disease, run by Evans Fernandez Perez at 1 site in United States.
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 15 inclusion and 29 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: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline to Week 52 in Percent Predicted FVC. (time frame: Up to 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958917, which also lists 3 linked publications.
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 Jan 2023.