Bronchiolitis ObliteransPhase 4MLK002NCT01211509
Montelukast in Bronchiolitis Obliterans Syndrome
A Phase 4 study testing Montelukast in people with Bronchiolitis Obliterans and Lung Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchiolitis Obliterans, Lung Transplantation, Graft Rejection
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Mar 2015
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fBOS
- Signed informed consent
- Age at least 18 years old at moment of transplantation
- Able to take oral medication
Who cannot join
- Retransplantation
- Previous organ transplantation
- Multi organ transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.
Read the detailed description
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or montelukast) to 'standard of care'
- 1:1 inclusion ratio (placebo:montelukast).
- Randomisation at diagnosis of chronic rejection after informed consent.
- Being tested
- Montelukast
- Keywords
- montelukast, cysteinyl leukotriene, lung transplantation, bronchiolitis obliterans syndrome
- Medical subject headings
- Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Montelukast TEVA
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
| Study group | Role | What they receive |
|---|---|---|
| montelukast sodium | Experimental | Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS Receives: Drug: Montelukast |
| placebo | Placebo comparator | Lactose monohydricum Ph.Eur. Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival/retransplantation rate after diagnosis of BOS
Measured: 1 year after diagnosis
survival/retransplantation rate at 2 years after diagnosis
Measured: 2 years after diagnosis
Secondary outcomes (5)
Obstructive and restrictive pulmonary function evolution
Measured: during 1 and 2 years of treatment
Bronchoalveolar lavage fluid (BAL)
BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
Measured: during 1 and 2 years of treatment
peripheral blood
peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content
Measured: during 1 and 2 years of treatment
Cytomegalovirus (CMV) and non-CMV infection rates
Measured: during 1 and 2 years of follow up
Acute rejection and lymphocytic bronchiolitis rates
Measured: after 1 and 2 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Geert Verleden, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Geert M Verleden, MD, PhD, Principal investigator, UZ gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211509
- Sponsor's protocol ID
- MLK002
- Acronym
- MLK002
- Status last verified
- Mar 2015
- First submitted
- 28 Sep 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Or R, Gesundheit B, Resnick I, Bitan M, Avraham A, Avgil M, Sacks Z, Shapira MY. Sparing effect by montelukast treatment for chronic graft versus host disease: a pilot study. Transplantation. 2007 Mar 15;83(5):577-81. doi: 10.1097/01.tp.0000255575.03795.df.
PubMed 17353777Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.
PubMed 18827151
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
- ClinicalTrials.gov ID
- NCT01211509
- Acronym / sponsor ID
- MLK002 / MLK002
- Keywords
- montelukast, cysteinyl leukotriene, lung transplantation, bronchiolitis obliterans syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Oct 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Sep 2010 (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.
Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.
Detailed description
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or montelukast) to 'standard of care'
- 1:1 inclusion ratio (placebo:montelukast).
- Randomisation at diagnosis of chronic rejection after informed consent.
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 |
|---|---|---|
| montelukast sodium | Experimental | Drug: MontelukastDaily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS |
| placebo | Placebo comparator | Drug: MontelukastLactose monohydricum Ph.Eur. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of fBOS
- Signed informed consent
- Age at least 18 years old at moment of transplantation
- Able to take oral medication
Key exclusion criteria (3 listed)
- Retransplantation
- Previous organ transplantation
- Multi organ transplantation
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 |
|---|---|---|
| MontelukastAlso: Montelukast TEVAAfter diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo | Drug | montelukast sodium, placebo |
Primary outcome
survival/retransplantation rate after diagnosis of BOS
Time frame: 1 year after diagnosis
survival/retransplantation rate at 2 years after diagnosis
Time frame: 2 years after diagnosis
5 secondary outcomes
Obstructive and restrictive pulmonary function evolution
Time frame: during 1 and 2 years of treatment
Bronchoalveolar lavage fluid (BAL)
Time frame: during 1 and 2 years of treatment
peripheral blood
Time frame: during 1 and 2 years of treatment
Cytomegalovirus (CMV) and non-CMV infection rates
Time frame: during 1 and 2 years of follow up
Acute rejection and lymphocytic bronchiolitis rates
Time frame: after 1 and 2 years of treatment
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 5 Mar 2015.
- Background: PubMed 17353777Or R, Gesundheit B, Resnick I, Bitan M, Avraham A, Avgil M, Sacks Z, Shapira MY. Sparing effect by montelukast treatment for chronic graft versus host disease: a pilot study. Transplantation. 2007 Mar 15;83(5):577-81. doi: 10.1097/01.tp.0000255575.03795.df.
- Background: PubMed 18827151Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.
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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.
Geert M Verleden, MD, PhD principal investigator
UZ gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Bronchiolitis Obliterans and Lung Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 3 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 5 Mar 2015. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
survival/retransplantation rate after diagnosis of BOS (time frame: 1 year after diagnosis). 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 NCT01211509, which also lists 2 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 5 Mar 2015.