Disorder Related to Lung TransplantationPhase 2NCT02363959
Hyperbaric Oxygen Therapy for Lung Transplantation
A Phase 2 study testing Hyperbaric Oxygen Therapy and Endobronchial Biopsy of Airway Epithelium in people with Disorder Related to Lung Transplantation and Central Airway Stenosis, run by Duke University at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on airway complications in post-lung transplant recipients with evidence of restricted levels of blood and oxygen in the airway tissue. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorder Related to Lung Transplantation, Central Airway Stenosis, Airway Exudative Plaques
- What is being tested?
- Hyperbaric Oxygen Therapy and Endobronchial Biopsy of Airway Epithelium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Sep 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-lung transplant patient
- Extensive exudative plaques at 1 month bronchoscopy
- No sign of airway improvement, or showing worsening of plaques at follow-up bronchoscopy 2-3 weeks after 1 month bronchoscopy.
Who cannot join
- Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%
- Use of extracorporeal membrane oxygenation
- Use of inhaled nitric oxide
- Presence of pneumothorax
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis
The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on airway complications in post-lung transplant recipients with evidence of restricted levels of blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in the early post-transplant period will be randomized to HBOT or usual care and followed clinically for 12 months following randomization. The investigators hypothesize that HBOT will decrease the number of airway complications in the treated subjects.
Read the detailed description
Hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician. The HBOT procedure used for this study will be identical to that used for clinical practice in the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology, including the oxygen that is used in the chamber. Patients will receive treatment through the regular clinical hyperbaric service. These are routine, not special, treatment sessions and they will receive them alongside other Duke University Medical Center patients being treated for other reasons. The medical grade oxygen used is a part of the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology hyperbaric chamber system.
While the patients randomized to receive usual care will not undergo HBOT, both study groups will receive standard serial bronchoscopies for airway clearance and for the collection of bronchoalveolar lavage fluid for culture data, due to the high rate of infection in lung transplant patients. All subjects will undergo the standard surveillance bronchoscopies every 3 to 4 weeks (x3) for clearance of the exudate from the airway, as well as monitoring progression of the airway abnormalities. As participants in this study, an, endobronchial biopsy of the airway epithelium will be performed at the main carina to collect a sample of recipient epithelium as well as at the first subcarina for each donor lung. Three samples will be collected from each of the biopsy sites. These samples are small (1 to 2 mm) and are thought to have a minimal clinical risk of minor bleeding associated with the procedure. Biopsy will add roughly 3 minutes total to each procedure.
- Conditions
- Disorder Related to Lung Transplantation, Central Airway Stenosis, Airway Exudative Plaques, Airway Complications Post-Lung Transplantation
- Being tested
- Hyperbaric Oxygen Therapy, Endobronchial Biopsy of Airway Epithelium
- Keywords
- Hyperbaric Oxygen, Lung Transplantation, Central Airway Stenosis, Airway Exudative Plaques, Hyperbaric Oxygen Therapy, Post-Lung Transplantation, Airway Ischemia, Endobronchial Biopsy, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDrug
Also called HBOT, Hyperbaric Oxygen
2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.
Endobronchial Biopsy of Airway EpitheliumProcedure or surgery
Also called Airway Biopsy
During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen, Airway Biopsy | Experimental | The hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.
During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure. Receives: Drug: Hyperbaric Oxygen Therapy; Procedure: Endobronchial Biopsy of Airway Epithelium |
| No Hyperbaric Oxygen, Airway Biopsy | Other | No hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure. Receives: Procedure: Endobronchial Biopsy of Airway Epithelium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.
Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.
Measured: 12 months
Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy
Pathologic specimens will be examined for the presence of acute cellular rejection.
Measured: 12 months
Secondary outcomes (4)
Number of Subjects With Development of Clinically Significant Airway Stenosis
Measured: 12 months
Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis
Measured: 12 months
Number of Subjects With Development of Clinically Significant Lung Infection
As defined by initiation of antimicrobials to treat the suspected organism.
Measured: 12 months
Number of Subjects With Development of Bronchitis Obliterans Syndrome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Duke 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Shofer, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363959
- Sponsor's protocol ID
- Pro00055849
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2015
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kraft BD, Mahmood K, Harlan NP, Hartwig MG, Snyder LD, Suliman HB, Shofer SL. Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation. J Heart Lung Transplant. 2021 Apr;40(4):269-278. doi: 10.1016/j.healun.2021.01.008. Epub 2021 Jan 15.
PubMed 33518452
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Lung Transplantation-Associated Pseudomembranes and Central Airway Stenosis
- ClinicalTrials.gov ID
- NCT02363959
- Acronym / sponsor ID
- Pro00055849
- Conditions
- Disorder Related to Lung Transplantation, Central Airway Stenosis, Airway Exudative Plaques, Airway Complications Post-Lung Transplantation
- Keywords
- Hyperbaric Oxygen, Lung Transplantation, Central Airway Stenosis, Airway Exudative Plaques, Hyperbaric Oxygen Therapy, Post-Lung Transplantation, Airway Ischemia, Endobronchial Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 17 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on airway complications in post-lung transplant recipients with evidence of restricted levels of blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in the early post-transplant period will be randomized to HBOT or usual care and followed clinically for 12 months following randomization. The investigators hypothesize that HBOT will decrease the number of airway complications in the treated subjects.
Detailed description
Hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician. The HBOT procedure used for this study will be identical to that used for clinical practice in the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology, including the oxygen that is used in the chamber. Patients will receive treatment through the regular clinical hyperbaric service. These are routine, not special, treatment sessions and they will receive them alongside other Duke University Medical Center patients being treated for other reasons. The medical grade oxygen used is a part of the Duke University Health System Center for Hyperbaric Medicine and Environmental Physiology hyperbaric chamber system.
While the patients randomized to receive usual care will not undergo HBOT, both study groups will receive standard serial bronchoscopies for airway clearance and for the collection of bronchoalveolar lavage fluid for culture data, due to the high rate of infection in lung transplant patients. All subjects will undergo the standard surveillance bronchoscopies every 3 to 4 weeks (x3) for clearance of the exudate from the airway, as well as monitoring progression of the airway abnormalities. As participants in this study, an, endobronchial biopsy of the airway epithelium will be performed at the main carina to collect a sample of recipient epithelium as well as at the first subcarina for each donor lung. Three samples will be collected from each of the biopsy sites. These samples are small (1 to 2 mm) and are thought to have a minimal clinical risk of minor bleeding associated with the procedure. Biopsy will add roughly 3 minutes total to each procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen, Airway Biopsy | Experimental | Drug: Hyperbaric Oxygen Therapy, Procedure: Endobronchial Biopsy of Airway EpitheliumThe hyperbaric oxygen therapy (HBOT) will be performed with the standard HBOT protocol used at Duke for the treatment of compromised grafts and flaps. This is 2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at atmospheric pressure of 2 (2 ATA) once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician. During standard bronchoscopies, an endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure. |
| No Hyperbaric Oxygen, Airway Biopsy | Other | Procedure: Endobronchial Biopsy of Airway EpitheliumNo hyperbaric oxygen therapy administered, but lung biopsy still completed during standard post-lung transplant bronchoscopies. An endobronchial biopsy of the airway epithelium will be performed. Biopsy will add roughly 3 minutes total to each procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-lung transplant patient
- Extensive exudative plaques at 1 month bronchoscopy
- No sign of airway improvement, or showing worsening of plaques at follow-up bronchoscopy 2-3 weeks after 1 month bronchoscopy.
Key exclusion criteria (6 listed)
- Use of mechanical ventilation with fraction of inspired oxygen(FiO2) greater than 40%
- Use of extracorporeal membrane oxygenation
- Use of inhaled nitric oxide
- Presence of pneumothorax
- Pregnancy
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 |
|---|---|---|
| Hyperbaric Oxygen TherapyAlso: HBOT, Hyperbaric Oxygen2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician. | Drug | Hyperbaric Oxygen, Airway Biopsy |
| Endobronchial Biopsy of Airway EpitheliumAlso: Airway BiopsyDuring standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung. | Procedure or surgery | Hyperbaric Oxygen, Airway Biopsy, No Hyperbaric Oxygen, Airway Biopsy |
Primary outcome
Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.
Time frame: 12 months
Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.
Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy
Time frame: 12 months
Pathologic specimens will be examined for the presence of acute cellular rejection.
4 secondary outcomes
Number of Subjects With Development of Clinically Significant Airway Stenosis
Time frame: 12 months
Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis
Time frame: 12 months
Number of Subjects With Development of Clinically Significant Lung Infection
Time frame: 12 months
Number of Subjects With Development of Bronchitis Obliterans Syndrome
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33518452Kraft BD, Mahmood K, Harlan NP, Hartwig MG, Snyder LD, Suliman HB, Shofer SL. Hyperbaric oxygen therapy to prevent central airway stenosis after lung transplantation. J Heart Lung Transplant. 2021 Apr;40(4):269-278. doi: 10.1016/j.healun.2021.01.008. Epub 2021 Jan 15.
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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.
Scott Shofer principal investigator
Duke 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 Hyperbaric Oxygen Therapy and Endobronchial Biopsy of Airway Epithelium in people with Disorder Related to Lung Transplantation and Central Airway Stenosis, run by Duke University 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 3 inclusion and 6 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 18 Nov 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. 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 17 Oct 2019). 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?
Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy. (time frame: 12 months). The study lists 2 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 NCT02363959, 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 18 Nov 2023.