Effect of Montelukast on Remodelling Markers in Asthmatic Children
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
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.