Effect of Montelukast on Remodelling Markers in Asthmatic Children

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: placebo; Drug: Montelukast

• Registration Number: NCT00875082
• Lead Sponsor: Universita di Verona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Study Start: 2010-02
• Primary Completion: 2011-09
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines.
• Stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. Atopy will be evaluated by skin-prick test to common allergens in the area.
• Confirmatory physical and laboratory findings:
• Age: ranging in age 6 to 14 years.
• Evidence of susceptibility to the disease under study
• Patients have not used ICS during 3-month period prior to study entry

Exclusion Criteria

• Patients will be excluded if they had used oral steroids in the last month.
• Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
• Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed
Montelukast	Montelukast	Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed

Primary Outcome Measures

Name	Time	Method
FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination	8 weeks

Trial Locations

Locations (1)

Pediatric Department, University of Verona; 🇮🇹 Verona, Italy