NCT01211509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

4.4 years

First QC Date

September 28, 2010

Last Update Submit

March 4, 2015

Conditions

Bronchiolitis ObliteransLung TransplantationGraft Rejection

Keywords

montelukastcysteinyl leukotrienelung transplantationbronchiolitis obliterans syndrome

Outcome Measures

Primary Outcomes (2)

  • survival/retransplantation rate after diagnosis of BOS

    1 year after diagnosis

  • survival/retransplantation rate at 2 years after diagnosis

    2 years after diagnosis

Secondary Outcomes (5)

  • Obstructive and restrictive pulmonary function evolution

    during 1 and 2 years of treatment

  • Bronchoalveolar lavage fluid (BAL)

    during 1 and 2 years of treatment

  • peripheral blood

    during 1 and 2 years of treatment

  • Cytomegalovirus (CMV) and non-CMV infection rates

    during 1 and 2 years of follow up

  • Acute rejection and lymphocytic bronchiolitis rates

    after 1 and 2 years of treatment

Study Arms (2)

montelukast sodium

EXPERIMENTAL

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

Drug: Montelukast

placebo

PLACEBO COMPARATOR

Lactose monohydricum Ph.Eur.

Drug: Montelukast

Interventions

MontelukastDRUG

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

Also known as: Montelukast TEVA
montelukast sodiumplacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Retransplantation
  • Previous organ transplantation
  • Multi organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Related 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. doi: 10.1097/01.tp.0000255575.03795.df.

    PMID: 17353777BACKGROUND

  • 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.

    PMID: 18827151BACKGROUND

MeSH Terms

Conditions

Bronchiolitis ObliteransBronchiolitis Obliterans Syndrome

Interventions

montelukast

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesOrganizing PneumoniaGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Geert M Verleden, MD, PhD

    UZ gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

BE(1)