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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 20, 2007

Last Updated Date

October 29, 2007

Start Date ^†

May 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00550758 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Historical Control, Crossover Assignment

Condition ^†

Asthma
Recurrent Cough

Intervention ^†

Drug: Methachoine
Device: spirometry

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

April 2007

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

3 Years to 6 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00550758

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Rambam Health Care Campus

Collaborators ^††

Investigators ^†

Study Director:	Lea Bentur, MD	Rambam Health Care Campus
Principal Investigator:	Daphna Vilozni, PhD	Rambam Health Care Campus

Information Provided By

Rambam Health Care Campus

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.