Effects of Montelukast in Children With Asthma - Full Text View

Sponsor:	Catholic University of the Sacred Heart
Collaborator:	Merck
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

Investigators

Principal Investigator:

Paolo Montuschi, M.D.

Catholic University of the Sacred Heart, Rome, Italy

More Information

No publications provided

Responsible Party:	Paolo Montuschi, M.D. Associate Professor of Pharmacology, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00675285 History of Changes
Obsolete Identifiers:	NCT00496496
Other Study ID Numbers:	A/1064/2004
Study First Received:	May 7, 2008
Last Updated:	May 8, 2008
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

Additional relevant MeSH terms:

Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Pathologic Processes
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012