Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years - Full Text View

Purpose

Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.

Condition	Intervention
Asthma Recurrent Cough	Drug: Methachoine Device: spirometry

MedlinePlus related topics:

Asthma Cough

ChemIDplus related topics:

Montelukast sodium Montelukast Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Crossover Assignment

Official Title:	The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1) [ Time Frame: after intervention ]

Enrollment:	84
Study Start Date:	May 2004
Study Completion Date:	April 2007

Intervention Details:

inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)

spirometry

Detailed Description:

We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.

Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).

Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.

Eligibility

Ages Eligible for Study:	3 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 3- to 6-years
respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9]
cough duration of more than 4 weeks
normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing.

Exclusion Criteria:

presence of other chronic respiratory conditions
emergency room visit or the presence of respiratory infection within the last month
oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
bronchodilator taken within 24-hours prior to the test.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550758

Sponsors and Collaborators

Rambam Health Care Campus

Investigators


Study Director:	Lea Bentur, MD	Rambam Health Care Campus

Principal Investigator:	Daphna Vilozni, PhD	Rambam Health Care Campus

More Information

Study ID Numbers:	McH-Spir- preschool_CTIL
First Received:	October 20, 2007
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00550758
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Methacholine challenge; Spirometry, Early childhood

Study placed in the following topic categories:

Montelukast

Hypersensitivity

Methacholine Chloride

Cough

Asthma

Recurrence

Additional relevant MeSH terms:

Parasympathomimetics

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Agonists

Bronchoconstrictor Agents

Miotics

Physiological Effects of Drugs

Cholinergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Muscarinic Agonists

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00550758