Bronchiolitis ObliteransNCT00502554
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
A study testing photopheresis in people with Bronchiolitis Obliterans, run by Hannover Medical School at 2 sites in Germany.
Trial summary
Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- photopheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2007to Mar 2010
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single/Double lung transplantation
- at least 6 months after lung transplantation
- bronchiolitis obliterans syndrome, Stadium > 1 (nach ISHLT 2001, FEV1 <80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction)
- none gastroesophageal reflux
- medication for > 3 months with Azithromycin with further decrease of FEV1, MEF 25-75
- bioptic prove that there is no acute rejection
- no improvement under steroid pulse therapy
Who cannot join
- tumor or hematologic disease
- acute rejection
- respiratory insufficiency (O2>2l/min, pCO2 >50 mm Hg)
- weight < 40 kg
- acute infection
- colonization with multiresistant pathogens
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department Pneumology, Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Medizinische Hochschule Hannover, Dep. Pneumology
Hanover, Lower Saxony, 30625
About this study
Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study
Read the detailed description
Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation.
This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- photopheresis
- Keywords
- lung function, FEV1
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photopheresisProcedure or surgery
Also called photopheresis by Therakos
2-day cycles of photopheresis every 3 weeks for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone. Receives: Procedure: photopheresis |
| 2 | Active comparator | 2-day cycles of photopheresis every 3 weeks for 3 months Receives: Procedure: photopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 stabilisation
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: insufficient patient recruitment and ECP capacity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Therakos
- Investigators
- Fuehner Thomas, Doctor, Principal investigator, Department Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502554
- Sponsor's protocol ID
- 4584
- Status last verified
- May 2008
- First submitted
- 16 Jul 2007
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
- ClinicalTrials.gov ID
- NCT00502554
- Acronym / sponsor ID
- 4584
- Conditions
- Bronchiolitis Obliterans
- Keywords
- lung function, FEV1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient recruitment and ECP capacity
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Therakos
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Jul 2007 (estimated)
- 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.
Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study
Detailed description
Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation.
This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Procedure: photopheresisObservation with standard care (macrolides, exercise, oxygen therapy etc.) alone. |
| 2 | Active comparator | Procedure: photopheresis2-day cycles of photopheresis every 3 weeks for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Single/Double lung transplantation
- at least 6 months after lung transplantation
- bronchiolitis obliterans syndrome, Stadium > 1 (nach ISHLT 2001, FEV1 <80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction)
- none gastroesophageal reflux
- medication for > 3 months with Azithromycin with further decrease of FEV1, MEF 25-75
Key exclusion criteria (6 listed)
- tumor or hematologic disease
- acute rejection
- respiratory insufficiency (O2>2l/min, pCO2 >50 mm Hg)
- weight < 40 kg
- acute infection
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 |
|---|---|---|
| photopheresisAlso: photopheresis by Therakos2-day cycles of photopheresis every 3 weeks for 3 months | Procedure or surgery | 1, 2 |
Primary outcome
FEV1 stabilisation
Time frame: 6 month
Results and safety
The study was stopped early (reason given: insufficient patient recruitment and ECP capacity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
Related trials for Bronchiolitis Obliterans
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
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.
Fuehner Thomas, Doctor principal investigator
Department Pneumology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photopheresis in people with Bronchiolitis Obliterans, run by Hannover Medical School at 2 sites in Germany.
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 7 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: stopped early, as of the sponsor's last update on 26 Jul 2011. 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 Germany. 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?
The study was stopped early (reason given: insufficient patient recruitment and ECP capacity). Results are not available in the source record.
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?
FEV1 stabilisation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2011.