Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006565
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-12-01
Brief Title:
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
Status:
COMPLETED
Status Verified Date:
2008-10
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 this study is to test the effects of reducing indoor environmental tobacco smoke ETS on unscheduled asthma visits asthma symptoms airway inflammation and exposure to tobacco smoke measured using air nicotine dosimeters serum and hair cotinine
Detailed Description:
BACKGROUND
Asthma a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli is emerging as the most prevalent and serious environmental health problem among children in the United States Numerous studies both prospective and cross-sectional suggest that exposure to ETS is one of the predominate risk factors for childhood asthma but this has not been confirmed in a controlled trial
DESIGN NARRATIVE
The randomized double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms The intervention consists of placement of 2 high efficiency air filtration with activated carbon potassium permanganate and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive placebo units in the control group homes The following hypotheses are tested 10 Children assigned to the ETS reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group 11 Children assigned to the ETS reduction group will have significant improvements in asthma symptoms compared with children in the control group 12 Children assigned to the ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled nitric oxide a measure of airway inflammation during one year of follow-up compared with the control group
Asthma a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli is emerging as the most prevalent and serious environmental health problem among children in the United States Numerous studies both prospective and cross-sectional suggest that exposure to ETS is one of the predominate risk factors for childhood asthma but this has not been confirmed in a controlled trial
DESIGN NARRATIVE
The randomized double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms The intervention consists of placement of 2 high efficiency air filtration with activated carbon potassium permanganate and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive placebo units in the control group homes The following hypotheses are tested 10 Children assigned to the ETS reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group 11 Children assigned to the ETS reduction group will have significant improvements in asthma symptoms compared with children in the control group 12 Children assigned to the ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled nitric oxide a measure of airway inflammation during one year of follow-up compared with the control group
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 |
|---|---|---|---|
| R01HL065731 | NIH | None | httpsreporternihgovquickSearchR01HL065731 |