Effect of Montelukast on Remodelling Markers in Asthmatic Children

NCT00875082 | Completed Phase 4

• 1 other identifier: UVAB-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Children; Remodelling; Metalloproteinases; Montelukast

Outcome Measures

Primary Outcomes (1)

• FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination

  8 weeks

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed

Drug: Montelukast

placebo

PLACEBO COMPARATOR

placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed

Drug: placebo

Interventions

Montelukast DRUG

Montelukast, chewing tablets 5mg, once daily, 8 weeks

Montelukast

placebo DRUG

placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks

placebo

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Pediatric Department, University of Verona

Verona, I-37134, Italy

Location

Related Publications (1)

• Tenero L, Piazza M, Sandri M, Azzali A, Chinellato I, Peroni D, Boner A, Piacentini G. Effect of montelukast on markers of airway remodeling in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):77-83. doi: 10.2500/aap.2016.37.3978.

  PMID: 27657514 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Attilio L Boner, MD

  Pediatric Department, Università di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: April 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

IT (1)