Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196547
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2005-09-12
Brief Title:
Montelukast in Modulating Exacerbations of Asthma in Children
Sponsor:
Firestone Institute for Respiratory Health
Organization:
Firestone Institute for Respiratory Health
Study Overview
Official Title:
Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children September 2005
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if Montelukast added to other therapy if any will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period
Detailed Description:
Between 1990- and 2003 we identified in Ontario and subsequently across Canada a striking increase in hospital admissions for asthma in children occurring predictably in the third week of September every year1 In 2000 we undertook a retrospective case-control study comparing the clinical characteristics of children using local emergency rooms for asthma in September with those of children presenting during the non-epidemic months of July-August Based on that pilot study of 169 children we developed a larger prospective case-control study of clinical and biological characteristics of children recruited as they presented to an emergency room for asthma during September 2001 The control group for this study were children recruited from the community who had symptomatic asthma but did not have a September exacerbation requiring emergency room utilization We identified the presence of rhinovirus in the majority of children attending an ER with acute asthma and also found rhinovirus in a substantial proportion of the community based controls We also found a highly significant difference in use of medications for asthma with the ER cases being much less likely to be receiving adequate anti-inflammatory medication In September 2004 we conducted a pilot randomized controlled blinded clinical trial of the efficacy of montelukast in reducing morbidity caused by asthma exacerbations associated with respiratory viral infections RVI in children aged 2 to 14 We found a highly significant reduction in reported symptom free days in the montelukast group The current study is a randomized placebo-controlled trial of montelukast during September 2005 to confirm the results of our pilot study and to examine the effectiveness of montelukast in reducing asthma morbidity during RVIs in different age and sex groups with a range of risk of exacerbations We also wish to compare the effectiveness of montelukast to placebo in reducing asthma morbidity during RVIs between groups of children concurrently taking no or other classes of asthma control medications
Study Oversight
Has Oversight DMC:
None
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?:
None