Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301171
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-03-09
Brief Title:
Treatment of Persistent Wheezing in Infants and Children
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Respiratory Function in Infants With Persistent Wheezing
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Wheezing is a high-pitched whistling sound that is produced when air flows through narrowed lung airways It is a common symptom of asthma Persistent wheezing is commonly treated with bronchodilators and inhaled steroids however when wheezing is temporarily caused by a virus or exposure to tobacco smoke this may not be the most effective treatment The purpose of this study is to evaluate the cause of wheezing in infants and children and to assess the effectiveness of inhaled steroids on improving lung function
Detailed Description:
Asthma prevalence has steadily increased in the United States since the early 1980s with infants and young children showing the largest increase Some young children experience wheezing but it is not known if this is related specifically to asthma Wheezing may be caused by a respiratory syncytial virus maternal smoking a family history of asthma or allergies In addition some infants who experience wheezing may have small or dysfunctional airways and may not respond well to commonly prescribed anti-inflammatory medications Because of the many causes of wheezing in order to prescribe the most effective treatment it is necessary to thoroughly assess lung function allergic sensitization and airway inflammation The purpose of this study is to examine the causes of moderate to severe wheezing in infants and assess the infants response to inhaled corticosteroid therapy The study will also assess new and safer ways to measure lung function and airway inflammation
This study will enroll infants with moderate to severe persistent wheezing At study entry participants will undergo lung function testing which will include a spirometry test measures of lung volumes and assessment of bronchodilator responsiveness Exhaled breath condensate and blood will be collected and skin-prick testing will be performed to test for allergies Participants will then be randomly assigned to receive either fluticasone an inhaled steroid or placebo for one month At the end of the month lung function testing will be performed and exhaled breath and serum measures will be collected to assess airway inflammation Participants will attend a follow-up evaluation at age 5 years During the evaluation lung function exhaled breath condensate and serum markers of inflammation will be measured again and skin-prick testing will also be performed again
This study will enroll infants with moderate to severe persistent wheezing At study entry participants will undergo lung function testing which will include a spirometry test measures of lung volumes and assessment of bronchodilator responsiveness Exhaled breath condensate and blood will be collected and skin-prick testing will be performed to test for allergies Participants will then be randomly assigned to receive either fluticasone an inhaled steroid or placebo for one month At the end of the month lung function testing will be performed and exhaled breath and serum measures will be collected to assess airway inflammation Participants will attend a follow-up evaluation at age 5 years During the evaluation lung function exhaled breath condensate and serum markers of inflammation will be measured again and skin-prick testing will also be performed again
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 |
|---|---|---|---|
| K23HL067881-04 | NIH | None | httpsreporternihgovquickSearchK23HL067881-04 |