Effects of Montelukast in Children With Asthma

Asthma Clinical Trial

Official title:

Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675285
• Other study ID #: A/1064/2004
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: May 8, 2008
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2008
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00496496

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-treatment fractional exhaled nitric oxide
Secondary	fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
Secondary	post-treatment FEV1
Secondary	post-treatment FVC
Secondary	post-treatment FEV1/FVC
Secondary	post-treatment FEF25%-75%
Secondary	FEV1 2 weeks after montelukast withdrawal
Secondary	FVC 2 weeks after montelukast withdrawal
Secondary	FEV1/FVC 2 weeks after montelukast withdrawal
Secondary	FEF25%-75% 2 weeks after montelukast withdrawal
Secondary	asthma exacerbation rate