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

Asthma Clinical Trial

— MCH-preschool  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00550758
• Other study ID #: McH-Spir- preschool_CTIL
• Status: Terminated
• Phase: N/A
• First received: October 20, 2007
• Last updated: October 29, 2007
• Start date: May 2004
• Est. completion date: April 2007

Study information

• Verified date: October 2007
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Recurrent Cough

Intervention

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

Device:
• spirometry
spirometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)		after intervention