Effect of Montelukast on Remodelling Markers in Asthmatic Children

NCT ID: NCT00875082

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Montelukast

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

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

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

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

Montelukast

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Boner Attilio

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Attilio L Boner, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Department, Università di Verona

Locations

Pediatric Department, University of Verona

Verona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 27657514 (View on PubMed)

Other Identifiers

UVAB-02

Identifier Type: -

Identifier Source: org_study_id