Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115297
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2005-06-21
Brief Title:
Montelukast for Early Life Wheezing
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Effects of Montelukast on Early Life Wheezing
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This study will determine the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who visit a physician for care of a wheezing illness Only patients from the Ankara area of Hacettepe University Medical Center in Turkey will be included in this study
Detailed Description:
BACKGROUND
Asthma has a large impact on the children of our society It is among the most common chronic diseases of childhood and is the leading cause of absenteeism from school It is unknown as to why more children are having recurrent episodes of wheezing and why some children have asthma while others do not There is increasing evidence that differences in innate immune responses among children can determine which child will have recurrent wheezing and asthma While many studies have focused on the factors that initiate innate immune responses there are relatively few studies of the downstream factors that cause abnormal airway responses There is evidence that eicosanoid mediators are part of the innate immune response and can function as its effector arm for allergic responses The ability of leukotrienes and prostaglandins to produce central features of the asthma phenotype is well described and there is emerging evidence that lipoxins facilitate restoration of allergic changes in the airways This study will test the hypothesis that the balance of airway eicosanoid expression during early-life wheezing illness and the genetically determined capacity to respond will predict recurrent wheezing Moreover an intervention to restore a more normal tissue response to this imbalance will reduce symptoms of early-life wheezing and subsequent recurrent episodes
DESIGN NARRATIVE
This will be a prospective double-blind randomized placebo-controlled parallel-group study of the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who are under the care of a physician for a wheezing illness Study treatment will be given for 56 days Participants who are 2 to 3 years old will receive either 5-mg montelukast tablets or matching placebo Participants who are 12 months to 2 years old will receive 4-mg montelukast granules or matching placebo The primary outcome parameter of this study will be the number of days that the infant is observed to be free of wheezing by the primary caregiver The secondary outcome parameters will be the number of wheezing episodes during the treatment period and the rate of recurrent wheezing during the follow-up period The study which is a consortium arrangement between the Brigham and Womens Hospital and the Hacettepe University Medical Center in Turkey will recruit children only from the Ankara area of Hacettepe University Medical Center in Turkey
This study will be one of three which include 1 measuring the airway eicosanoid profiles of pediatric wheezing patients 3 months to 3 years old 2 determining if genetic variants in eicosanoid metabolic and response pathways are associated with recurrent wheezing and 3 determining how intervention with montelukast singulair affects symptoms and the rate of recurrent wheezing
Asthma has a large impact on the children of our society It is among the most common chronic diseases of childhood and is the leading cause of absenteeism from school It is unknown as to why more children are having recurrent episodes of wheezing and why some children have asthma while others do not There is increasing evidence that differences in innate immune responses among children can determine which child will have recurrent wheezing and asthma While many studies have focused on the factors that initiate innate immune responses there are relatively few studies of the downstream factors that cause abnormal airway responses There is evidence that eicosanoid mediators are part of the innate immune response and can function as its effector arm for allergic responses The ability of leukotrienes and prostaglandins to produce central features of the asthma phenotype is well described and there is emerging evidence that lipoxins facilitate restoration of allergic changes in the airways This study will test the hypothesis that the balance of airway eicosanoid expression during early-life wheezing illness and the genetically determined capacity to respond will predict recurrent wheezing Moreover an intervention to restore a more normal tissue response to this imbalance will reduce symptoms of early-life wheezing and subsequent recurrent episodes
DESIGN NARRATIVE
This will be a prospective double-blind randomized placebo-controlled parallel-group study of the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who are under the care of a physician for a wheezing illness Study treatment will be given for 56 days Participants who are 2 to 3 years old will receive either 5-mg montelukast tablets or matching placebo Participants who are 12 months to 2 years old will receive 4-mg montelukast granules or matching placebo The primary outcome parameter of this study will be the number of days that the infant is observed to be free of wheezing by the primary caregiver The secondary outcome parameters will be the number of wheezing episodes during the treatment period and the rate of recurrent wheezing during the follow-up period The study which is a consortium arrangement between the Brigham and Womens Hospital and the Hacettepe University Medical Center in Turkey will recruit children only from the Ankara area of Hacettepe University Medical Center in Turkey
This study will be one of three which include 1 measuring the airway eicosanoid profiles of pediatric wheezing patients 3 months to 3 years old 2 determining if genetic variants in eicosanoid metabolic and response pathways are associated with recurrent wheezing and 3 determining how intervention with montelukast singulair affects symptoms and the rate of recurrent wheezing
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL080073 | NIH | None | httpsreporternihgovquickSearchR01HL080073 |