Effects of Montelukast in Children With Asthma - Full Text View

Sponsors and Collaborators:	Catholic University of the Sacred Heart Merck Sharp and Dohme
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00675285

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: placebo	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

post-treatment fractional exhaled nitric oxide [ Designated as safety issue: No ]

Secondary Outcome Measures:

fractional exhaled nitric oxide 2 weeks after montelukast withdrawal [ Designated as safety issue: No ]
post-treatment FEV1 [ Designated as safety issue: No ]
post-treatment FVC [ Designated as safety issue: No ]
post-treatment FEV1/FVC [ Designated as safety issue: No ]
post-treatment FEF25%-75% [ Designated as safety issue: No ]
FEV1 2 weeks after montelukast withdrawal [ Designated as safety issue: No ]
FVC 2 weeks after montelukast withdrawal [ Designated as safety issue: No ]
FEV1/FVC 2 weeks after montelukast withdrawal [ Designated as safety issue: No ]
FEF25%-75% 2 weeks after montelukast withdrawal [ Designated as safety issue: No ]
asthma exacerbation rate

Enrollment:	26
Study Start Date:	September 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: montelukast sodium one tablet 5 mg once/day for 4 weeks
2: Placebo Comparator	Drug: placebo one tablet 5 mg once/day for 4 weeks

Eligibility

Ages Eligible for Study:	6 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675285

Locations

Italy
Catholic University of the Sacred Heart
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Merck Sharp and Dohme

Investigators

Principal Investigator:

Paolo Montuschi, M.D.

Catholic University of the Sacred Heart, Rome, Italy

More Information

Responsible Party:	Catholic University of the Sacred Heart ( Paolo Montuschi, M.D. Associate Professor of Pharmacology )
Study ID Numbers:	A/1064/2004
Study First Received:	May 7, 2008
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00675285
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:

airway inflammation
childhood asthma
fractional exhaled nitric oxide
leukotriene receptor antagonists
lung function

Study placed in the following topic categories:

Montelukast
Nitric Oxide
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009