A randomized placebo-controlled double blind study to treat BOS.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-021983-14-BE
• Date of registration: 02/09/2010
• Prospective Registration: Yes
• Primary sponsor: UZ Gasthuisberg
• Public title: A randomized placebo-controlled double blind study to treat BOS.
• Scientific title: A randomized placebo-controlled double blind study to treat BOS.
• Date of first enrolment: 23/09/2010
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021983-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Retransplantation
•Previous transplantation (solid organ)
•Multi-organ transplantation (lung+ other solid organ)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

-Mortality at 1 and 2 year post diagnosis of BOS -Infection rate during BOS -Evolution of pulmonary function after diagnosis of BOS
MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low

Intervention(s)

Trade Name: Montelukast Teva
Product Name: montelukast teva
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MONTELUKAST SODIUM
CAS Number: 151767-02-1
Current Sponsor code: RVG100911
Other descriptive name: Singulair
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): •The survival/retransplantation rate at 1 and 2 y post-diagnosis fBOS
•Obstructive and restrictive pulmonary function evolution
•BAL: cells (neutrophils, lymfocytes, fibrocytes)
proteins (RAGE, HGF, IL8, MMP8/9, LTD4),
microbiology
•Peripheral blood: CRP and fibrocytes
•Acute rejection and lymphocytic bronchiolitis rates
•CMV and non-CMV infection rates
•Gastroesophageal reflux (clinical and biochemical approach)

Main Objective: The survival/retransplantation rate at 1 and 2 y post-diagnosis fBOS

Secondary Objective: •Obstructive and restrictive pulmonary function evolution
•BAL: cells (neutrophils, lymfocytes, fibrocytes)
proteins (RAGE, HGF, IL8, MMP8/9, LTD4),
microbiology
•Peripheral blood: CRP and fibrocytes
•Acute rejection and lymphocytic bronchiolitis rates
•CMV and non-CMV infection rates
•Gastroesophageal reflux (clinical and biochemical approach)

Secondary ID(s)

MLK002