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Effects of Montelukast in Children With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
montelukast sodium
placebo
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring airway inflammation, childhood asthma, fractional exhaled nitric oxide, leukotriene receptor antagonists, lung function

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic University of the Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

post-treatment fractional exhaled nitric oxide

Secondary Outcome Measures

fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
post-treatment FEV1
post-treatment FVC
post-treatment FEV1/FVC
post-treatment FEF25%-75%
FEV1 2 weeks after montelukast withdrawal
FVC 2 weeks after montelukast withdrawal
FEV1/FVC 2 weeks after montelukast withdrawal
FEF25%-75% 2 weeks after montelukast withdrawal
asthma exacerbation rate

Full Information

First Posted
May 7, 2008
Last Updated
May 8, 2008
Sponsor
Catholic University of the Sacred Heart
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00675285
Brief Title
Effects of Montelukast in Children With Asthma
Official Title
Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
airway inflammation, childhood asthma, fractional exhaled nitric oxide, leukotriene receptor antagonists, lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
montelukast sodium
Intervention Description
one tablet 5 mg once/day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one tablet 5 mg once/day for 4 weeks
Primary Outcome Measure Information:
Title
post-treatment fractional exhaled nitric oxide
Secondary Outcome Measure Information:
Title
fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
Title
post-treatment FEV1
Title
post-treatment FVC
Title
post-treatment FEV1/FVC
Title
post-treatment FEF25%-75%
Title
FEV1 2 weeks after montelukast withdrawal
Title
FVC 2 weeks after montelukast withdrawal
Title
FEV1/FVC 2 weeks after montelukast withdrawal
Title
FEF25%-75% 2 weeks after montelukast withdrawal
Title
asthma exacerbation rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Montuschi, M.D.
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Effects of Montelukast in Children With Asthma

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