Effect of Montelukast on Remodelling Markers in Asthmatic Children (MORACH)
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|ClinicalTrials.gov Identifier: NCT00875082|
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : June 19, 2013
Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. No data are available, at the present, about the potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.
In the present study, the investigators aim to assess whether the addition of montelukast to ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1 ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma.
Children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (T1): 1) group A: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in these patients beta agonist therapy only.
All children will be evaluated after 8 weeks (T2). They will be tested for lung function, FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Montelukast Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Montelukast on Metalloproteinase (MMP)-9, MMP-12, Tissue Inhibitor Metalloproteinase-1 (TIMP-1), Procollagen Type I C-terminal Peptide (PICP) and TGF-beta1 Levels in Sputum From Mild Intermittent Asthmatic Children: a Pilot Study|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||April 2013|
U.S. FDA Resources
Active Comparator: Montelukast
Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed
Montelukast, chewing tablets 5mg, once daily, 8 weeks
Placebo Comparator: placebo
placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed
placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks
- FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875082
|Pediatric Department, University of Verona|
|Verona, Italy, I-37134|
|Principal Investigator:||Attilio L Boner, MD||Pediatric Department, Università di Verona|