EmphysemaPhase 2DEPTHNCT05382208
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
A Phase 2 study testing Doxycycline in people with Emphysema and HIV, run by Weill Medical College of Cornell University at 20 sites in United States.
Trial summary
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1… Read more about this study
- Who is it for?
- Ages 30 years and older
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Aug 2022to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 30 years and older at screening visit.
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to the enrollment visit, and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- Current or former smoker with at least a 3 pack-year history of cigarette smoking at screening visit.
- Evidence of emphysema on high resolution CT (HRCT) of the chest done at pre-entry visit (Visit 2). Emphysema is defined as either:
- Mild, moderate, or severe emphysema assessed by central reader(s) at the CT Imaging Core; or
- Quantification of ≥ 5% of voxels with density < -950 Hounsfield Units (HU) as quantified by the CT Imaging Core.
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- All participants with emphysema by either or both criteria must have ≤ 35% of voxels with density < -950 HU.
- Screening and Entry DLCO measurements must be within 15% of each other. The PFT quality at both visits must be acceptable based on ATS Quality Criteria.
- Screening (Visit 1) Pulmonary Function Test meets ATS quality criteria as determined by a central reviewer at the PFT Reading Core (UCLA)
- Baseline (Visit 2) Pulmonary Function Test meets ATS quality criteria as determined by the central reviewer at the PFT Reading Core (UCLA), Site Investigator, or DEPTH Trial Leadership.
- HIV-1 RNA level < 200 copies/ml within 90 days prior to the Entry/Baseline visit by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
- CD4 cell count > 100 cells/mm3 within 90 days prior to the Entry/Baseline visit.by any US laboratory that has a CLIA certification or its equivalent.
- Stable antiretroviral therapy for greater than or equal to 8 weeks prior to the Entry/Baseline visit. Substitutions of one formulation of a drug for another are not considered changes in antiretroviral therapy for the purpose of defining stable therapy..
- Serum ALT and AST < 3 x upper limit of normal within 60 days prior to the Entry/Baseline visit.
- Participants on therapy for COPD must be on stable therapy for at least 4 weeks prior to the Entry/Baseline visit.
- Documentation of serum alpha-1-antitrypsin level above the lower limit of normal from a test done at any time prior to the Entry/Baseline visit.
- Provision of signed and dated written informed consent.
- Stated willingness to adhere to all study procedures and anticipated availability for the duration of the study.
- Life expectancy > 2 years in the opinion of the site investigator.
- Ability to take oral medication and willingness to adhere to the study drug.
- For individuals of reproductive potential, negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mIU/mL at the screening visit. This will be repeated at the Entry/Baseline visit.
Who cannot join
- Pulmonary infection, acute COPD exacerbation, acute opportunistic infection within 30 days prior to the Screening Visit 1 or Entry/Baseline Visit 2.
- Any acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the Entry/Baseline visit.
- Decompensated cirrhosis defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
- History of, or planned, wedge resection, lobectomy, pneumonectomy, or lung volume reduction surgery.
- History of, or planned, endobronchial valve placement for lung volume reduction.
- Significant parenchymal lung disease other than emphysema or chronic bronchitis (e.g. sarcoidosis, MAI infection, pulmonary fibrosis, lung cancer, bullae/cysts from prior Pneumocystis pneumonia) that would preclude accurate quantification of emphysema.
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- Previous allergy or intolerance to doxycycline or other drugs in the tetracycline class (e.g. minocycline, tetracycline).
- Breastfeeding individuals.
- Receipt of any investigational* drug within 30 days prior to the Entry/Baseline visit. Note: for the purpose of this protocol, investigational drug refers to a drug that is not FDA approved for any indication. COVID vaccines available under emergency use authorization are allowed.
- Need for concomitant use of barbiturates; carbamazepine; phenytoin
- Use of systemic retinoids (eg. Isotretinoin [Accutane]) or Vitamin A within 30 days prior to the Entry/Baseline visit. Note: Multivitamin containing Vitamin A use is permitted.
- Use of any systemic antibiotic (e.g., doxycycline or other tetracycline, azithromycin) within 7 days prior to the Entry/Baseline visit.
- Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- History of recurrent C. difficile infection or C. difficile infection within 30 days prior to the Entry/Baseline visit.
- Inability to stop supplemental oxygen for 15 minutes to perform a DLCO maneuver.
- Has changes to the chest that preclude adequate HRCT imaging (e.g. Metallic objects in the chest such as shrapnel or pacemaker leads)
- Current receipt of, or anticipated need to initiate, hemodialysis or peritoneal dialysis.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University
Atlanta, Georgia, 30329
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
SUNY Downstate Medical School
Brooklyn, New York, 11203
University of North Carolina
Chapel Hill, North Carolina, 27514
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Case Western University
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
Duke University School of Medicine
Durham, North Carolina, 27704
University of Texas, McGovern Medical School
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095
Miami University
Miami, Florida, 33136
Tulane University
New Orleans, Louisiana, 70112
Weill Cornell Medicine
New York, New York, 10065
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
University of California San Diego
San Diego, California, 92103
University of Washington
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections.
Read the detailed description
This study is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial in approximately 250 people living with HIV who have emphysema.
Eligible participants will be randomized in a 1:1 fashion to doxycycline or placebo. Participants will receive 100 mg doxycycline orally or matched placebo twice a day for 72 weeks.
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 100 mg orally twice a day.
PlaceboDrug
Matching placebo orally twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Doxycycline 100mg orally twice a day Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Matching placebo orally twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline (slope) of percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (indicated as ppDLCOadj) over the 72 week treatment period.
Measured: 72 weeks
Secondary outcomes (22)
Change from baseline to week 48 in 6 minute walk test distance.
Measured: 48 weeks
Change from baseline to week 72 in 6 minute walk test distance.
Measured: 72 weeks
Change from baseline to week 48 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Measured: 48 weeks
Change from baseline to week 72 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Measured: 72 weeks
Change from baseline to week 72 in percentage of voxels < -950 Hounsfield Units (HU)
Measured: 72 weeks
Change from baseline to week 48 in the COPD Activity Test (CAT) score
The COPD Assessment Test (CAT): CAT is an 8-item self-administered questionnaire. Scores range from 0 to 40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 48 weeks
Change from baseline to week 72 in the COPD Activity Test (CAT) score
The COPD Assessment Test (CAT): CAT is an 8-item self-administered questionnaire. Scores range from 0 to 40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 72 weeks
Change from baseline to week 48 in St. George's Respiratory Questionnaire (SGRQ) score
St. George's Respiratory Questionnaire (SGRQ): SGRQ is a 50-item respiratory disease-specific health-related quality of life (HRQOL) instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 48 weeks
Change from baseline to week 72 in St. George's Respiratory Questionnaire (SGRQ) score
St. George's Respiratory Questionnaire (SGRQ): SGRQ is a 50-item respiratory disease-specific health-related quality of life (HRQOL) instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 72 weeks
Change from baseline to week 48 in forced expiratory volume in 1 second (FEV1) (L)
Measured: 48 weeks
Change from baseline to week 72 in forced expiratory volume in 1 second (FEV1) (L)
Measured: 72 weeks
Change from baseline to week 48 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
Measured: 48 weeks
Change from baseline to week 72 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
Measured: 72 weeks
The number of adverse events
The number of adverse events regardless of relatedness to the intervention
Measured: 72 weeks
The proportion of participants with at least 1 adverse event
The proportion of participants with at least 1 adverse event regardless of relatedness to the intervention
Measured: 72 weeks
The number of serious adverse events.
Serious adverse events (SAEs) will include all treatment-emergent SAEs.
Measured: 72 weeks
The proportion of participants with at least 1 serious adverse event.
The proportion of participants with at least 1 Serious adverse event (SAE). SAEs will include all treatment-emergent SAEs.
Measured: 72 weeks
The proportion of participants with deaths.
Measured: 72 weeks
The number of participants permanently discontinuing study medication due to adverse events.
The number of participants permanently discontinuing study medication due to treatment-emergent adverse events.
Measured: 72 weeks
The proportion of participants permanently discontinuing study medication due to adverse events.
The proportion of participants permanently discontinuing study medication due to treatment-emergent adverse events.
Measured: 72 weeks
The number of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
Measured: 72 weeks
The proportion of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start22 Aug 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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 EmphysemaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, Los Angeles, University of Iowa, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Marshall J Glesby, MD, PhD, Principal investigator, Weill Medical College of Cornell UniversityCathie Spino, ScD, Principal investigator, University of MichiganRobert J Kaner, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382208
- Sponsor's protocol ID
- 22-02-307/22-04024723
- Other IDs
- DEPTH-001, UH3HL154944
- Acronym
- DEPTH
- Status last verified
- Jan 2026
- First submitted
- 16 May 2022
- Last updated
- 26 Jan 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
Kaner RJ, O'Beirne SL, Krambrink A, Spino C, Yang HS, Zhu YS, Crystal RG, Glesby MJ. Randomized Double-Blinded Pilot Study of Doxycycline for HIV-Associated COPD and Emphysema. Chronic Obstr Pulm Dis. 2026 Sep 30. doi: 10.15326/jcopdf.2026.0796. Online ahead of print.
PubMed 42852919
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
- ClinicalTrials.gov ID
- NCT05382208
- Acronym / sponsor ID
- DEPTH / 22-02-307/22-04024723
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, Los Angeles, University of Iowa, University of Michigan
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 May 2022 (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 determine if doxycycline will reduce progression of emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections.
Detailed description
This study is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial in approximately 250 people living with HIV who have emphysema.
Eligible participants will be randomized in a 1:1 fashion to doxycycline or placebo. Participants will receive 100 mg doxycycline orally or matched placebo twice a day for 72 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: DoxycyclineDoxycycline 100mg orally twice a day |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo orally twice a day |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female age 30 years and older at screening visit.
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to the enrollment visit, and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- Current or former smoker with at least a 3 pack-year history of cigarette smoking at screening visit.
- Evidence of emphysema on high resolution CT (HRCT) of the chest done at pre-entry visit (Visit 2). Emphysema is defined as either:
- All participants with emphysema by either or both criteria must have ≤ 35% of voxels with density < -950 HU.
Key exclusion criteria (17 listed)
- Pulmonary infection, acute COPD exacerbation, acute opportunistic infection within 30 days prior to the Screening Visit 1 or Entry/Baseline Visit 2.
- Any acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the Entry/Baseline visit.
- Decompensated cirrhosis defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
- History of, or planned, wedge resection, lobectomy, pneumonectomy, or lung volume reduction surgery.
- History of, or planned, endobronchial valve placement for lung volume reduction.
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 |
|---|---|---|
| DoxycyclineDoxycycline 100 mg orally twice a day. | Drug | Doxycycline |
| PlaceboMatching placebo orally twice a day. | Drug | Placebo |
Primary outcome
Rate of decline (slope) of percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (indicated as ppDLCOadj) over the 72 week treatment period.
Time frame: 72 weeks
22 secondary outcomes
Change from baseline to week 48 in 6 minute walk test distance.
Time frame: 48 weeks
Change from baseline to week 72 in 6 minute walk test distance.
Time frame: 72 weeks
Change from baseline to week 48 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Time frame: 48 weeks
Change from baseline to week 72 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Time frame: 72 weeks
Change from baseline to week 72 in percentage of voxels < -950 Hounsfield Units (HU)
Time frame: 72 weeks
Change from baseline to week 48 in the COPD Activity Test (CAT) score
Time frame: 48 weeks
Change from baseline to week 72 in the COPD Activity Test (CAT) score
Time frame: 72 weeks
Change from baseline to week 48 in St. George's Respiratory Questionnaire (SGRQ) score
Time frame: 48 weeks
Change from baseline to week 72 in St. George's Respiratory Questionnaire (SGRQ) score
Time frame: 72 weeks
Change from baseline to week 48 in forced expiratory volume in 1 second (FEV1) (L)
Time frame: 48 weeks
Change from baseline to week 72 in forced expiratory volume in 1 second (FEV1) (L)
Time frame: 72 weeks
Change from baseline to week 48 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
Time frame: 48 weeks
Change from baseline to week 72 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
Time frame: 72 weeks
The number of adverse events
Time frame: 72 weeks
The proportion of participants with at least 1 adverse event
Time frame: 72 weeks
The number of serious adverse events.
Time frame: 72 weeks
The proportion of participants with at least 1 serious adverse event.
Time frame: 72 weeks
The proportion of participants with deaths.
Time frame: 72 weeks
The number of participants permanently discontinuing study medication due to adverse events.
Time frame: 72 weeks
The proportion of participants permanently discontinuing study medication due to adverse events.
Time frame: 72 weeks
The number of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
Time frame: 72 weeks
The proportion of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
Time frame: 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 42852919Kaner RJ, O'Beirne SL, Krambrink A, Spino C, Yang HS, Zhu YS, Crystal RG, Glesby MJ. Randomized Double-Blinded Pilot Study of Doxycycline for HIV-Associated COPD and Emphysema. Chronic Obstr Pulm Dis. 2026 Sep 30. doi: 10.15326/jcopdf.2026.0796. Online ahead of print.
- 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.
Marshall J Glesby, MD, PhD principal investigator
Weill Medical College of Cornell University
Cathie Spino, ScD principal investigator
University of Michigan
Robert J Kaner, MD principal investigator
Weill Medical College of Cornell University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline in people with Emphysema and HIV, run by Weill Medical College of Cornell University at 20 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 21 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of decline (slope) of percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (indicated as ppDLCOadj) over the 72 week treatment period. (time frame: 72 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 NCT05382208, 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 26 Jan 2026.