Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years (MCH-preschool)

October 29, 2007 updated by: Rambam Health Care Campus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

October 20, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (ESTIMATE)

October 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2007

Last Update Submitted That Met QC Criteria

October 29, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • McH-Spir- preschool_CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe