Status:
COMPLETED
Effect of Montelukast on Remodelling Markers in Asthmatic Children
Lead Sponsor:
Universita di Verona
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00875082
Start Date
February 1 2010
End Date
April 1 2013
Last Update
June 19 2013
Active Locations (1)
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1
Pediatric Department, University of Verona
Verona, Italy, I-37134