Effect of Montelukast on Remodelling Markers in Asthmatic Children (MORACH)

U

University of Verona

Status and phase

Completed
Phase 4

Conditions

Asthma

Treatments

Drug: Montelukast
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00875082
UVAB-02

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Montelukast
Active Comparator group
Description:
Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed
Treatment:
Drug: Montelukast
placebo
Placebo Comparator group
Description:
placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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