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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montelukast sodium | Experimental | Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS |
|
| placebo | Placebo Comparator | Lactose monohydricum Ph.Eur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival/retransplantation rate after diagnosis of BOS | 1 year after diagnosis | |
| survival/retransplantation rate at 2 years after diagnosis | 2 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive and restrictive pulmonary function evolution | during 1 and 2 years of treatment | |
| Bronchoalveolar lavage fluid (BAL) | BAL will be used to assess cellularity, protein and mRNA concentration and microbiology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geert M Verleden, MD, PhD | UZ gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17353777 | Background | 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. | |
| 18827151 | Background | 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. |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| during 1 and 2 years of treatment |
| 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 |
| 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 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000092124 | Organizing Pneumonia |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |