NCT00875082

Effect of Montelukast on Remodelling Markers in Asthmatic Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Montelukast	Montelukast, chewing tablets 5mg, once daily, 8 weeks
DRUG	placebo	placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-09-01
• Completion: 2013-04-01
• First posted: 2009-04-03
• Last updated: 2013-06-19

Locations

1 site across 1 country: Italy