Clinical trial NCT00875082: Effect of Montelukast on Remodelling Markers in Asthmatic Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Children
Remodelling
Metalloproteinases
Montelukast
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Pediatric Department, University of Verona
Study officials:
affiliation: Pediatric Department, Università di Verona
name: Attilio L Boner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.