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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021983-14-BE

Enrollment

Registered

2010-09-02

Start date

2010-09-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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: RV

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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);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)	—

Measure

Time frame

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);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)

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Countries

Belgium

Outcome results