A RANDOMIZED TRIAL TO REDUCE ETS IN CHILDREN WITH ASTHMA
Project Number5R01HL065731-02
Contact PI/Project LeaderLANPHEAR, BRUCE P
Awardee OrganizationCINCINNATI CHILDRENS HOSP MED CTR
Description
Abstract Text
DESCRIPTION (Adapted from applicant's abstract): The objective of this proposal
is to improve our understanding of the role that environmental tobacco smoke
(ETS) plays in asthma. 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. This
proposed study will be the first large scale, controlled trial utilizing
passive controls designed to test the effects of reducing indoor ETS on asthma
symptoms, pulmonary function, airway inflammation (as measured with expired
nitric oxide), and health services utilization. We request 48 months of support
to conduct a randomized, double-blind prospective trial involving 240 children
with doctor-diagnosed asthma who are exposed to environmental tobacco smoke, to
test the efficacy of reducing such exposure on asthma symptoms. The
intervention consists of placement of 2 high efficiency air filtration with
activated carbon, potassium permanganate and zeolite filter insert (HEPA-CPZ)
to reduce exposure to ETS in the experimental homes and inactive (placebo)
units in the control group homes. We will test the following hypotheses: (1.0)
Children assigned to the ETS reduction group will have significant improvements
in asthma symptoms and pulmonary function compared with children in the control
group. (1.1) Children assigned to the ETS reduction group will have >25 percent
reduction in exacerbations of asthma during one year of follow-up compared with
those in the control group. (1.2) Children assigned to the ETS reduction group
will have improvement in pulmonary function as measured by >10 percent
difference in forced expiratory volume at 1 second (FEV 1) and >15 percent
difference in forced expiratory fraction of 25 percent-75 percent (FEF25-75
percent) at 12-month follow-up compared with those in the control group. (1.3)
Children assigned to the ETS reduction group will have > 10 percent reduction
in exhaled nitric oxide, a measure of airway inflammation during one year of
follow-up compared with the control group. (1.4) Children assigned to the ETS
reduction group will have a >20 percent reduction in health services
utilization for asthma during one-year follow-up compared with those in the
control group. (2.0) Children who are exposed to higher levels of ETS, as
measured by cotinine, will experience higher rates of asthma symptoms and
diminished pulmonary function in a dose-response relationship.
Our proposed randomized, controlled trial, consisting of biologic markers of
exposure, will provide evidence of a causal pathway between the exposure to
environmental tobacco smoke and asthma, substantially improve our understanding
of the contribution of environmental tobacco smoke to childhood asthma, and
provide important information to develop prevention strategies.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
air filtrationasthmabehavioral /social science research tagchild (0-11)clinical researchclinical trialsdisease /disorder proneness /riskenvironmental exposurehairhealth care service utilizationhealth services research taghuman subjectlongitudinal human studynicotinenitric oxidepassive smokingrespiratory functionspirometryurinalysis
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