Interstitial Lung DiseaseNCT03901534
Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD
A study testing Continuous positive airway pressure (CPAP) therapy and Nox A1 Recorder in people with Interstitial Lung Disease and Obstructive Sleep Apnea, run by Columbia University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (OSA) and interstitial lung disease (ILD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure (CPAP) therapy and Nox A1 Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,021 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2023to 16 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent.
- Age 18 years or greater
- Diagnosis of any of the following fibrotic interstitial lung diseases as defined by ATS/ERS/JRS/ALAT guidelines and research statements and Delphi surveys:
- Idiopathic pulmonary fibrosis
- Idiopathic non-specific interstitial pneumonia (NSIP) with fibrosis
- Chronic hypersensitivity pneumonitis with fibrosis
Show all 10Show fewer
- Connective tissue disease related interstitial lung disease (CTD-ILD)
- Unclassifiable idiopathic interstitial pneumonia with fibrosis
- Age 18 years or greater
- Clinical diagnosis of untreated OSA documented by nocturnal polysomnography
Who cannot join
- Clinically significant lung disease other than fibrotic interstitial lung disease
- Planned change to the IPF treatment during the study period
- Current cigarette smoking (past 4 weeks)
- Lower respiratory tract infection in past 60 days. (Upper respiratory tract infection is not a contraindication)
- History of life-threatening cardiac arrhythmias
- Known chronic heart failure (LVEF < 45% or echo evidence of RV dysfunction or PH)
Show all 12Show fewer
- Chronic opiate analgesic use
- History of sleepiness-related automobile accident within past year of enrollment
- Expected survival time in the opinion of the investigator of less than 6 months
- History of stroke or spinal cord injury
- Current treatment with CPAP or oral appliance
- Identical exclusion criteria as for ILD patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Columbia University Medical Center
New York, New York, 10032
About this study
The purpose of this study is to evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (OSA) and interstitial lung disease (ILD).
Read the detailed description
This study is comprised of 3 aims:
Aim 1: Determine whether the greater OSA severity is associated with higher levels of serum biomarkers of AEC and endothelial injury and ECM remodeling in community-dwelling adults. This is a retrospective study that will analyze biospecimens from those who participated in the MESA sleep study [Chen et al].
Aim 2: Determine whether CPAP use is associated with reductions in alveolar epithelial cell (AEC) injury and endothelial injury, and extracellular matrix (ECM) remodeling biomarkers in adults with moderate-to-severe OSA. This is a retrospective study that will analyze biospecimens from those who participated in either the HeartBEAT [Gottlieb et al] and BestAIR [Bakker et al] studies.
Revised Aim 3: a) Determine whether untreated OSA promotes AEC and endothelial injury and ECM remodeling biomarkers in adults with ILD and OSA compared with those without OSA; b) Determine prospectively whether clinically-initiated 4-week PAP therapy increases markers of alveolar endothelial lung injury in OSA. Participants will be recruited at Columbia University and be assigned CPAP therapy as an intervention.
- Conditions
- Interstitial Lung Disease, Obstructive Sleep Apnea
- Being tested
- Continuous positive airway pressure (CPAP) therapy, Nox A1 Recorder
- Keywords
- Interstitial Lung Disease (ILD), Obstructive Sleep Apnea (OSA), CPAP
- Medical subject headings
- Lung Diseases, Interstitial, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP) therapyDevice
Standard, clinically used CPAP therapy. CPAP will be prescribed by the participants' clinician provider and not by the study investigators.
Nox A1 RecorderDevice
Non-invasive, body-worn, sleep recording device for nocturnal polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Community based Multi-Ethnic Study of Atherosclerosis (MESA) | No intervention | This cohort includes biospecimens collected from 1852 participants in the MESA sleep study [Chen et al]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont. All participants in this cohort will be analyzed for only the Aim 1 outcome measures. |
| HeartBEAT and BestAir | No intervention | The cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT [Gottlieb et al] and BestAIR [Bakker et al] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study. Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine. All participants in this cohort will be analyzed for only the Aim 2 outcome measures. |
| CPAP treatment of OSA | Experimental | Participants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP).
All participants in this cohort will be analyzed for only the Aim 3a outcome measures. Receives: Device: Continuous positive airway pressure (CPAP) therapy |
| ILD screening for OSA | Experimental | Participants with interstitial lung disease (ILD) will be screened for OSA by polysomnography.
All participants in this cohort will be analyzed for only the Aim 3b outcome measures. Receives: Device: Nox A1 Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant Protein D (SP-D) [Aim 1]
SP-D is a marker of alveolar epithelial cell injury.
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Measured: 1 day
E-selectin [Aim 1]
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Measured: 1 day
Angiopoietin-2 [Aim 1]
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Measured: 1 day
Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Measured: 1 day
Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Measured: 1 day
Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]
The differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.
This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Measured: Baseline and post-CPAP follow-up, up to 24 Weeks
Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]
The between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.
This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Measured: Baseline and post-CPAP follow-up, up to 24 Weeks
Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]
The between-arm difference in the longitudinal changes of Ang-2 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.
This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Measured: Baseline and post-CPAP follow-up, up to 24 Weeks
Change in Serum Osteopontin Following CPAP [Aim 2]
The differences between-arms in the longitudinal changes of Osteopontin will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm.
This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Measured: Baseline and post-CPAP follow-up, up to 24 Weeks
Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]
Participants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy.
This Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jan 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Why it stopped: Enrollment challenges
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.
- More trials run by Columbia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sanja Jelic, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901534
- Sponsor's protocol ID
- AAAR6902
- Other IDs
- 1R01HL137234-01
- Status last verified
- Dec 2024
- First submitted
- 2 Apr 2019
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Researchers will be required to submit a written request to the Study Principal Investigator (PI) describing the use of the specimens. The researcher must also document institutional review board (IRB) approval and sign a material transfer agreement. The Study PI will make all decisions about use of the specimens. No identifiable information will be released, only coded anonymized samples and non-identifiable clinical/demographic information. For genomic data generated from whole-exome sequencing, the genotype and relevant phenotype data for participants who consented to share data will be registered and shared through the database of Genotypes and Phenotypes (dbGaP), a controlled access database, once the sequencing data have been cleaned and quality control procedures are completed.
Publications
Chen X, Wang R, Zee P, Lutsey PL, Javaheri S, Alcantara C, Jackson CL, Williams MA, Redline S. Racial/Ethnic Differences in Sleep Disturbances: The Multi-Ethnic Study of Atherosclerosis (MESA). Sleep. 2015 Jun 1;38(6):877-88. doi: 10.5665/sleep.4732.
PubMed 25409106Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
PubMed 24918372Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.
PubMed 27018174
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Continuous Positive Airway Pressure Therapy in OSA and ILD
- ClinicalTrials.gov ID
- NCT03901534
- Acronym / sponsor ID
- AAAR6902
- Conditions
- Interstitial Lung Disease, Obstructive Sleep Apnea
- Keywords
- Interstitial Lung Disease (ILD), Obstructive Sleep Apnea (OSA), CPAP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges
- Enrolment
- 2,021 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 20 Dec 2024
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 evaluate whether biomarkers of lung epithelial and endothelial injury are associated with obstructive sleep apnea (OSA) and interstitial lung disease (ILD).
Detailed description
This study is comprised of 3 aims:
Aim 1: Determine whether the greater OSA severity is associated with higher levels of serum biomarkers of AEC and endothelial injury and ECM remodeling in community-dwelling adults. This is a retrospective study that will analyze biospecimens from those who participated in the MESA sleep study [Chen et al].
Aim 2: Determine whether CPAP use is associated with reductions in alveolar epithelial cell (AEC) injury and endothelial injury, and extracellular matrix (ECM) remodeling biomarkers in adults with moderate-to-severe OSA. This is a retrospective study that will analyze biospecimens from those who participated in either the HeartBEAT [Gottlieb et al] and BestAIR [Bakker et al] studies.
Revised Aim 3: a) Determine whether untreated OSA promotes AEC and endothelial injury and ECM remodeling biomarkers in adults with ILD and OSA compared with those without OSA; b) Determine prospectively whether clinically-initiated 4-week PAP therapy increases markers of alveolar endothelial lung injury in OSA. Participants will be recruited at Columbia University and be assigned CPAP therapy as an intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community based Multi-Ethnic Study of Atherosclerosis (MESA) | No intervention | –This cohort includes biospecimens collected from 1852 participants in the MESA sleep study [Chen et al]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont. All participants in this cohort will be analyzed for only the Aim 1 outcome measures. |
| HeartBEAT and BestAir | No intervention | –The cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT [Gottlieb et al] and BestAIR [Bakker et al] studies. Participants were selected for this analysis based on mean PAP adherence of ≥4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study. Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine. All participants in this cohort will be analyzed for only the Aim 2 outcome measures. |
| CPAP treatment of OSA | Experimental | Device: Continuous positive airway pressure (CPAP) therapyParticipants with obstructive sleep apnea (OSA) will be treated with continuous positive airway pressure therapy (CPAP). All participants in this cohort will be analyzed for only the Aim 3a outcome measures. |
| ILD screening for OSA | Experimental | Device: Nox A1 RecorderParticipants with interstitial lung disease (ILD) will be screened for OSA by polysomnography. All participants in this cohort will be analyzed for only the Aim 3b outcome measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to provide informed consent.
- Age 18 years or greater
- Diagnosis of any of the following fibrotic interstitial lung diseases as defined by ATS/ERS/JRS/ALAT guidelines and research statements and Delphi surveys:
- Age 18 years or greater
- Clinical diagnosis of untreated OSA documented by nocturnal polysomnography
Key exclusion criteria (12 listed)
- Clinically significant lung disease other than fibrotic interstitial lung disease
- Planned change to the IPF treatment during the study period
- Current cigarette smoking (past 4 weeks)
- Lower respiratory tract infection in past 60 days. (Upper respiratory tract infection is not a contraindication)
- History of life-threatening cardiac arrhythmias
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP) therapyStandard, clinically used CPAP therapy. CPAP will be prescribed by the participants' clinician provider and not by the study investigators. | Device | CPAP treatment of OSA |
| Nox A1 RecorderNon-invasive, body-worn, sleep recording device for nocturnal polysomnography. | Device | ILD screening for OSA |
Primary outcome
Surfactant Protein D (SP-D) [Aim 1]
Time frame: 1 day
SP-D is a marker of alveolar epithelial cell injury. This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
E-selectin [Aim 1]
Time frame: 1 day
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Angiopoietin-2 [Aim 1]
Time frame: 1 day
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Vascular Endothelial Growth Factor-A (VEGF-A) [Aim 1]
Time frame: 1 day
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Angiopoietin-interacting Soluble Tie-2 (sTie2) [Aim 1]
Time frame: 1 day
This Outcome is specific to Aim 1 and will only be measured on participants in the Aim 1 phase of the study.
Change in Serum Matrix Metalloproteinase-7 (MMP-7) Following CPAP [Aim 2]
Time frame: Baseline and post-CPAP follow-up, up to 24 Weeks
The differences between-arms in the longitudinal changes of MMP-7 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Change in Serum Surfactant Protein-D (SP-D) Following CPAP [Aim 2]
Time frame: Baseline and post-CPAP follow-up, up to 24 Weeks
The between-arm difference in the longitudinal changes of SP-D will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Change in Serum Angiopoietin-2 (Ang-2) Following CPAP [Aim 2]
Time frame: Baseline and post-CPAP follow-up, up to 24 Weeks
The between-arm difference in the longitudinal changes of Ang-2 will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Change in Serum Osteopontin Following CPAP [Aim 2]
Time frame: Baseline and post-CPAP follow-up, up to 24 Weeks
The differences between-arms in the longitudinal changes of Osteopontin will be measured. For the purpose of this analysis, all individuals receiving active CPAP in the experimental arm will be compared to all individuals receiving sham CPAP device in the control arm. This Outcome is specific to Aim 2 and will only be measured on participants in the Aim 2 phase of the study.
Serum Angiopoietin-2 (Ang-2, ng/mL) [Aim 3a]
Time frame: Baseline and 4 weeks
Participants will be treated with CPAP for 4 weeks. Serum Ang-2 levels will be measured at baseline and after CPAP therapy. This Outcome is specific to Aim 3a and will only be measured on participants in the Aim 3a phase of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25409106Chen X, Wang R, Zee P, Lutsey PL, Javaheri S, Alcantara C, Jackson CL, Williams MA, Redline S. Racial/Ethnic Differences in Sleep Disturbances: The Multi-Ethnic Study of Atherosclerosis (MESA). Sleep. 2015 Jun 1;38(6):877-88. doi: 10.5665/sleep.4732.
- Background: PubMed 24918372Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766.
- Background: PubMed 27018174Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.
- Individual participant dataSharing planned: Yes. Researchers will be required to submit a written request to the Study Principal Investigator (PI) describing the use of the specimens. The researcher must also document institutional review board (IRB) approval and sign a material transfer agreement. The Study PI will make all decisions about use of the specimens. No identifiable information will be released, only coded anonymized samples and non-identifiable clinical/demographic information. For genomic data generated from whole-exome sequencing, the genotype and relevant phenotype data for participants who consented to share data will be registered and shared through the database of Genotypes and Phenotypes (dbGaP), a controlled access database, once the sequencing data have been cleaned and quality control procedures are completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP) therapy and Nox A1 Recorder in people with Interstitial Lung Disease and Obstructive Sleep Apnea, run by Columbia University at 2 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 10 inclusion and 12 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). 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?
Surfactant Protein D (SP-D) [Aim 1] (time frame: 1 day). The study lists 10 primary outcomes in all. 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 NCT03901534, 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 20 Dec 2024.