Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-28 @ 11:16 PM
Study NCT ID:
NCT00550758
Status:
TERMINATED
Last Update Posted:
2007-10-30
First Post:
2007-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study has recently ended, all information gathred as planed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCH-preschool
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: