NCT00550758

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2004

Typical duration for not_applicable asthma

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
Last Updated

October 30, 2007

Status Verified

October 1, 2007

First QC Date

October 20, 2007

Last Update Submit

October 29, 2007

Conditions

AsthmaRecurrent Cough

Keywords

Methacholine challenge; Spirometry, Early childhood

Outcome Measures

Primary Outcomes (1)

  • Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)

    after intervention

Interventions

MethachoineDRUG

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

spirometryDEVICE

spirometry

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaCough

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Lea Bentur, MD

    Rambam Health Care Campus

    STUDY DIRECTOR

  • Daphna Vilozni, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2007

First Posted

October 30, 2007

Study Start

May 1, 2004

Study Completion

April 1, 2007

Last Updated

October 30, 2007

Record last verified: 2007-10