Idiopathic Pulmonary FibrosisPhase 3PRECISIONSNCT04300920
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
A Phase 3 study testing N-acetyl cysteine in people with Idiopathic Pulmonary Fibrosis, run by Fernando J Martinez at 25 sites in United States.
Trial summary
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 25 sitesUnited States
- Study dates
- 17 Dec 2020to 2 Mar 2026
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 40 years of age
- Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
- Signed informed consent
- If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
- Confirmed rs3570920 TT TOLLIP genotype
Who cannot join
- Pregnancy or planning to become pregnant
- Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation
- Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
- Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
- Supplemental or prescribed NAC therapy within 60 days of enrollment
- Listed for lung transplantation at the time of screening
Show all 10Show fewer
- History of lung cancer
- Inability to perform spirometry
- Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
- Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Piedmont Healthcare
Austell, Georgia, 30106
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Ohio State University
Columbus, Ohio, 43221
University of Texas Southwestern
Dallas, Texas, 75390
Indiana University
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90033
Loyola University
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
Lisa Lancaster
Nashville, Tennessee, 37204
Tulane University
New Orleans, Louisiana, 70112
Weill Cornell Medicine
New York, New York, 10016
Temple University
Philadelphia, Pennsylvania, 19140
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of Utah Health
Salt Lake City, Utah, 84108
University of Texas Health San Antonio
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
University of Arizona
Tucson, Arizona, 85724
About this study
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality]
The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype.
Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- N-acetyl cysteine, Placebo
- Keywords
- IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
PlaceboDrug
Matching oral placebo tablet three times daily for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | 600 mg oral N-acetylcysteine (NAC) three times daily for 24 months. Receives: Drug: N-acetyl cysteine |
| Placebo | Placebo comparator | Placebo tablet three times daily for 24 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.
This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Measured: 24 months
Secondary outcomes (34)
Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
This is a composite endpoint of time to 10% relative decline in FVC % predicted, based on the global lung initiative (GLI) reference equation, first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Measured: 24 months
Time to death from any cause
Measured: 24 months
Time to first respiratory hospitalization, lung transplant, or death from any cause
Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
Measured: 24 months
Time to 10% relative decline in FVC, lung transplant or death from any cause
Measured: 24 months
Time to lung transplant, or death from any cause
Measured: 24 months
Time to 10% relative decline in FVC %predicted, lung transplant, or death from any cause
Measured: 24 months
Time to first all-cause hospitalization, lung transplant, or death from any cause
Measured: 24 months
Annualized rate of respiratory hospitalizations
Measured: 24 months
Annualized rate of non-elective, all-cause hospitalizations
Measured: 24 months
Absolute change in FVC % predicted from randomization at 12 months
Measured: 12 months
Absolute change in FVC % predicted from randomization at 24 months
Measured: 24 months
Absolute change in FVC from randomization at 12 months
Measured: 12 months
Absolute change in FVC from randomization at 24 months
Measured: 24 months
Absolute change in diffusing capacity of the lung for carbon monoxide (DLCO) uncorrected for hemoglobin from randomization at 12 months
Measured: 12 months
Absolute change in DLCO uncorrected from randomization at 24 months
Measured: 24 months
Absolute change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.
Measured: 12 months
Absolute change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.
Measured: 12 months
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.
Measured: 12 months
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.
Measured: 12 months
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.
Measured: 12 months
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months
Measured: 24 months
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months
Measured: 24 months
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months
Measured: 24 months
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months
Measured: 24 months
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months
Measured: 24 months
Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems
Measured: 24 months
Estimated time per six months free of 10% relative decline in FVC, first respiratory hospitalization, lung transplant or death from any cause.
Measured: 24 months
Estimated time per six months free of 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
Measured: 24 months
Estimated time lived per six months (based on all-cause mortality).
Measured: 24 months
Average time per six months free of first respiratory hospitalization, lung transplantation or death from any cause.
Measured: 24 months
Average time per six months free of 10% relative decline in FVC, lung transplant, or death from any cause.
Measured: 24 months
Average time per six months free of lung transplant, or death from any cause.
Measured: 24 months
Average time per six months free of 10% relative decline in FVC % predicted, lung transplant, or death from any cause.
Measured: 24 months
Average time per six months free of all-cause hospitalization, lung transplant, or death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start17 Dec 2020
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally three times daily or matched placebo for 24 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernando J Martinez
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Michigan, Pulmonary Fibrosis Foundation, University of Washington, National Heart, Lung, and Blood Institute (NHLBI), Three Lakes Foundation
- Responsible party
- Sponsor-investigator, Fernando J Martinez, University of Massachusetts, Worcester
- Investigators
- Fernando J Martinez, MD, Principal investigator, University of Massachusetts, WorcesterImre Noth, MD, Principal investigator, University of VirginiaKevin Flaherty, MS, MD, Principal investigator, University of MichiganCathie Spino, ScD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300920
- Sponsor's protocol ID
- 19-12021232
- Other IDs
- 1U24HL145265-01A1
- Acronym
- PRECISIONS
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with NHLBI data sharing policies.
Publications
Podolanczuk AJ, Kim JS, Cooper CB, Lasky JA, Murray S, Oldham JM, Raghu G, Flaherty KR, Spino C, Noth I, Martinez FJ; PRECISIONS Study Team. Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial. BMC Pulm Med. 2022 Dec 13;22(1):475. doi: 10.1186/s12890-022-02281-8.
PubMed 36514019
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
- ClinicalTrials.gov ID
- NCT04300920
- Acronym / sponsor ID
- PRECISIONS / 19-12021232
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Fernando J MartinezUniversity, hospital or other
- Collaborators
- University of Virginia, University of Michigan, Pulmonary Fibrosis Foundation, University of Washington, National Heart, Lung, and Blood Institute (NHLBI), Three Lakes Foundation
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 9 Mar 2020 (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.
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality]
The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype.
Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally three times daily or matched placebo for 24 months.
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetyl cysteine600 mg oral N-acetylcysteine (NAC) three times daily for 24 months. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet three times daily for 24 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 40 years of age
- Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
- Signed informed consent
- If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
- Confirmed rs3570920 TT TOLLIP genotype
Key exclusion criteria (10 listed)
- Pregnancy or planning to become pregnant
- Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation
- Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
- Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
- Supplemental or prescribed NAC therapy within 60 days of enrollment
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 |
|---|---|---|
| N-acetyl cysteineAlso: NAC600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months. | Drug | N-acetylcysteine |
| PlaceboMatching oral placebo tablet three times daily for 24 months. | Drug | Placebo |
Primary outcome
Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause.
Time frame: 24 months
This is a composite endpoint of time to 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. Respiratory hospitalizations will be determined by a blinded clinical events classification (adjudication) committee.
34 secondary outcomes
Time to one of the following composite criteria: 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
Time frame: 24 months
Time to death from any cause
Time frame: 24 months
Time to first respiratory hospitalization, lung transplant, or death from any cause
Time frame: 24 months
Time to 10% relative decline in FVC, lung transplant or death from any cause
Time frame: 24 months
Time to lung transplant, or death from any cause
Time frame: 24 months
Time to 10% relative decline in FVC %predicted, lung transplant, or death from any cause
Time frame: 24 months
Time to first all-cause hospitalization, lung transplant, or death from any cause
Time frame: 24 months
Annualized rate of respiratory hospitalizations
Time frame: 24 months
Annualized rate of non-elective, all-cause hospitalizations
Time frame: 24 months
Absolute change in FVC % predicted from randomization at 12 months
Time frame: 12 months
Absolute change in FVC % predicted from randomization at 24 months
Time frame: 24 months
Absolute change in FVC from randomization at 12 months
Time frame: 12 months
Absolute change in FVC from randomization at 24 months
Time frame: 24 months
Absolute change in diffusing capacity of the lung for carbon monoxide (DLCO) uncorrected for hemoglobin from randomization at 12 months
Time frame: 12 months
Absolute change in DLCO uncorrected from randomization at 24 months
Time frame: 24 months
Absolute change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 12 months.
Time frame: 12 months
Absolute change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 12 months.
Time frame: 12 months
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 12 months.
Time frame: 12 months
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 12 months.
Time frame: 12 months
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 12 months.
Time frame: 12 months
Change in patient reported outcomes scores for the Leicester Cough Questionnaire (LCQ) from randomization at 24 months
Time frame: 24 months
Change in patient reported outcomes scores for the EuroQoL EQ-5D Questionnaire from randomization at 24 months
Time frame: 24 months
Change in patient reported outcomes scores for the University of California, San Diego Shortness of Breath (UCSD-SOB) Questionnaire from randomization at 24 months
Time frame: 24 months
Change in patient reported outcomes scores for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from randomization at 24 months
Time frame: 24 months
Change in patient reported outcomes scores for the St. George's Respiratory Questionnaire (SGRQ) from randomization at 24 months
Time frame: 24 months
Proportion of participants with and number of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and unanticipated problems
Time frame: 24 months
Estimated time per six months free of 10% relative decline in FVC, first respiratory hospitalization, lung transplant or death from any cause.
Time frame: 24 months
Estimated time per six months free of 10% relative decline in FVC % predicted, first respiratory hospitalization, lung transplant or death from any cause.
Time frame: 24 months
Estimated time lived per six months (based on all-cause mortality).
Time frame: 24 months
Average time per six months free of first respiratory hospitalization, lung transplantation or death from any cause.
Time frame: 24 months
Average time per six months free of 10% relative decline in FVC, lung transplant, or death from any cause.
Time frame: 24 months
Average time per six months free of lung transplant, or death from any cause.
Time frame: 24 months
Average time per six months free of 10% relative decline in FVC % predicted, lung transplant, or death from any cause.
Time frame: 24 months
Average time per six months free of all-cause hospitalization, lung transplant, or death from any cause.
Time frame: 24 months
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 20 Mar 2026.
- Derived from this study: PubMed 36514019Podolanczuk AJ, Kim JS, Cooper CB, Lasky JA, Murray S, Oldham JM, Raghu G, Flaherty KR, Spino C, Noth I, Martinez FJ; PRECISIONS Study Team. Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial. BMC Pulm Med. 2022 Dec 13;22(1):475. doi: 10.1186/s12890-022-02281-8.
- Individual participant dataSharing planned: Yes. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with NHLBI data sharing policies.
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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.
Fernando J Martinez, MD principal investigator
University of Massachusetts, Worcester
Imre Noth, MD principal investigator
University of Virginia
Kevin Flaherty, MS, MD principal investigator
University of Michigan
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetyl cysteine in people with Idiopathic Pulmonary Fibrosis, run by Fernando J Martinez at 25 sites 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 5 inclusion and 10 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to one of the following composite endpoint criteria: 10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplant or death from any cause. (time frame: 24 months). 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 NCT04300920, which also lists 1 linked publication.
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 20 Mar 2026.