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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550758

Acronym

MCH-preschool

Enrollment

Registered

2007-10-30

Start date

2004-05-31

Completion date

2007-04-30

Last updated

2007-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Recurrent Cough

Keywords

Methacholine challenge; Spirometry, Early childhood

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.

Interventions

DRUGMethachoine

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

DEVICEspirometry

spirometry

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026