Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00035685 |
| Other study ID # |
998 |
| Secondary ID |
R01HL068828 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 4, 2002 |
| Last updated |
February 17, 2016 |
| Start date |
December 2001 |
| Est. completion date |
November 2006 |
Study information
| Verified date |
January 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To examine whether or not primary school-aged children with asthma from low-income
households have lower household environmental tobacco smoke (ETS) exposure than matched
control children.
Description:
BACKGROUND:
Children with asthma are particularly vulnerable to environmental tobacco smoke (ETS).
However, despite this special vulnerability to ETS, children with asthma are at least as
likely to live in smoking households, as are healthy children. Controversy exists, however,
about whether or not the smoking members of households with children with asthma use
specific strategies to reduce the harmful effects of their smoking on their children more
than the smoking members of households of healthy children.
DESIGN NARRATIVE:
The case-control study examines whether or not primary school-aged children with asthma from
low-income households have lower household ETS exposure than matched control children.
Household ETS exposure will be measured by both objective monitoring, specifically passive
nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report
(the secondary hypothesis). Ninety children with physician diagnosed asthma and smoking
mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90
healthy children. All children will be recruited from Metro Denver clinics providing
services to low-income, underserved populations. The sample will contain equal numbers of
African Americans, Hispanics, and Whites. Recruitment will target low-income populations due
to their increased prevalence of, and associated morbidity from both asthma and tobacco
smoking. Specific household smoking behaviors, as reported by mothers, will be examined for
association with household nicotine and child cotinine levels. Finally, a set of carefully
chosen measures will be examined in tertiary, exploratory analyses to help understand,
clarify, and contextualize the observed results.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
