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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211509
Other study ID # MLK002
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2010
Last updated March 4, 2015
Start date October 2010
Est. completion date March 2015

Study information

Verified date March 2015
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products (FAGG)Belgium: Ethics Committee
Study type Interventional

Clinical 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 montelukast can indeed slow down the progression of chronic rejection after lung transplantation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Montelukast
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Locations

Country Name City State
Belgium UZ Gasthuisberg Leuven

Sponsors (2)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary survival/retransplantation rate after diagnosis of BOS 1 year after diagnosis No
Primary survival/retransplantation rate at 2 years after diagnosis 2 years after diagnosis No
Secondary Obstructive and restrictive pulmonary function evolution during 1 and 2 years of treatment No
Secondary Bronchoalveolar lavage fluid (BAL) BAL will be used to assess cellularity, protein and mRNA concentration and microbiology during 1 and 2 years of treatment No
Secondary peripheral blood peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content during 1 and 2 years of treatment No
Secondary Cytomegalovirus (CMV) and non-CMV infection rates during 1 and 2 years of follow up No
Secondary Acute rejection and lymphocytic bronchiolitis rates after 1 and 2 years of treatment No
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