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Montelukast in Bronchiolitis Obliterans Syndrome (MLK002)

Primary Purpose

Bronchiolitis Obliterans, Lung Transplantation, Graft Rejection

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Montelukast
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis Obliterans focused on measuring montelukast, cysteinyl leukotriene, lung transplantation, bronchiolitis obliterans syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of fBOS
  • Signed informed consent
  • Age at least 18 years old at moment of transplantation
  • Able to take oral medication

Exclusion Criteria:

  • Retransplantation
  • Previous organ transplantation
  • Multi organ transplantation

Sites / Locations

  • UZ Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

montelukast sodium

placebo

Arm Description

Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS

Lactose monohydricum Ph.Eur.

Outcomes

Primary Outcome Measures

survival/retransplantation rate after diagnosis of BOS
survival/retransplantation rate at 2 years after diagnosis

Secondary Outcome Measures

Obstructive and restrictive pulmonary function evolution
Bronchoalveolar lavage fluid (BAL)
BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
peripheral blood
peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content
Cytomegalovirus (CMV) and non-CMV infection rates
Acute rejection and lymphocytic bronchiolitis rates

Full Information

First Posted
September 28, 2010
Last Updated
March 4, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01211509
Brief Title
Montelukast in Bronchiolitis Obliterans Syndrome
Acronym
MLK002
Official Title
A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans, Lung Transplantation, Graft Rejection
Keywords
montelukast, cysteinyl leukotriene, lung transplantation, bronchiolitis obliterans syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
montelukast sodium
Arm Type
Experimental
Arm Description
Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Lactose monohydricum Ph.Eur.
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Montelukast TEVA
Intervention Description
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
Primary Outcome Measure Information:
Title
survival/retransplantation rate after diagnosis of BOS
Time Frame
1 year after diagnosis
Title
survival/retransplantation rate at 2 years after diagnosis
Time Frame
2 years after diagnosis
Secondary Outcome Measure Information:
Title
Obstructive and restrictive pulmonary function evolution
Time Frame
during 1 and 2 years of treatment
Title
Bronchoalveolar lavage fluid (BAL)
Description
BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
Time Frame
during 1 and 2 years of treatment
Title
peripheral blood
Description
peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content
Time Frame
during 1 and 2 years of treatment
Title
Cytomegalovirus (CMV) and non-CMV infection rates
Time Frame
during 1 and 2 years of follow up
Title
Acute rejection and lymphocytic bronchiolitis rates
Time Frame
after 1 and 2 years of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of fBOS Signed informed consent Age at least 18 years old at moment of transplantation Able to take oral medication Exclusion Criteria: Retransplantation Previous organ transplantation Multi organ transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert M Verleden, MD, PhD
Organizational Affiliation
UZ gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
17353777
Citation
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.
Results Reference
background
PubMed Identifier
18827151
Citation
Vanaudenaerde 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.
Results Reference
background

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Montelukast in Bronchiolitis Obliterans Syndrome

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