Official Title: “Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma”

Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma. A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.

A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2006

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • one tablet 5 mg once/day for 4 weeks
• Drug: placebo
  • one tablet 5 mg once/day for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• post-treatment fractional exhaled nitric oxide
  • Safety Issue?: No

Secondary Measures

• fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
  • Safety Issue?: No
• post-treatment FEV1
  • Safety Issue?: No
• post-treatment FVC
  • Safety Issue?: No
• post-treatment FEV1/FVC
  • Safety Issue?: No
• post-treatment FEF25%-75%
  • Safety Issue?: No
• FEV1 2 weeks after montelukast withdrawal
  • Safety Issue?: No
• FVC 2 weeks after montelukast withdrawal
  • Safety Issue?: No
• FEV1/FVC 2 weeks after montelukast withdrawal
  • Safety Issue?: No
• FEF25%-75% 2 weeks after montelukast withdrawal
  • Safety Issue?: No
• asthma exacerbation rate

Inclusion Criteria:

• Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
• exhaled nitric oxide (NO) >20 PPB at visit 2
• symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
• no regular medication, inhaled short-acting beta-2 agonists for symptom relief

Exclusion Criteria:

• Patient is hospitalized
• Patient has FEV1 < 80% predicted on visit 1
• Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
• upper respiratory infection in the previous 3 weeks
• treatment with glucocorticoids or LTRAs in the previous 4 weeks
• treatment with inhaled glucocorticoids for more than 4 weeks in the previous year

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Catholic University of the Sacred Heart

Overall Clinical Trial Officials and Contacts

Paolo Montuschi, M.D. Principal Investigator Catholic University of the Sacred Heart, Rome, Italy  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675285

Study ID Number: A/1064/2004

ClinicalTrials.gov Identifier: NCT00675285

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health