Effects of Montelukast in Children With Asthma
Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
1 other identifier
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Sep 2005
Shorter than P25 for phase_3 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 9, 2008
CompletedMay 9, 2008
May 1, 2008
10 months
May 7, 2008
May 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-treatment fractional exhaled nitric oxide
Secondary Outcomes (10)
fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
post-treatment FEV1
post-treatment FVC
post-treatment FEV1/FVC
post-treatment FEF25%-75%
- +5 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catholic University of the Sacred Heartlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Catholic University of the Sacred Heart
Rome, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Montuschi, M.D.
Catholic University of the Sacred Heart
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 9, 2008
Study Start
September 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
May 9, 2008
Record last verified: 2008-05