Viewing Study NCT00341445



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00341445
Status: COMPLETED
Last Update Posted: 2018-04-05
First Post: 2006-06-19

Brief Title: Cockroach Allergen Reduction by Extermination Alone in Low-Income Urban Homes A Randomized Control Trial
Sponsor: National Institute of Environmental Health Sciences NIEHS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Cockroach Allergen Reduction by Extermination Alone in Low-Income Urban Homes-A Randomized Control Trial
Status: COMPLETED
Status Verified Date: 2013-09-11
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 most important risk factor for asthma in inner-city homes may be exposure to cockroach allergen In a previous study the researchers reported that extermination alone without resident education or professional cleaning reduced allergen levels in inner-city homes This result contradicted earlier findings by other scientists This study seeks to confirm the researchers earlier results and to determine how intensive an effective extermination must be

The study will last one year and include 60 infested multi-unit rental homes in North Carolina divided into three groups In the Treatment-1 group researchers from North Carolina State University will set insecticide bait in initial and follow-up visits as the highest standard for treatment In the Treatment-2 group one of five commercial pest-control companies will be randomly assigned to treat each home according to a 12-month pre-paid contract The third group will be a control group that receives no extermination treatment In all homes researchers will periodically survey the residents monitor cockroach numbers and monitor allergen levels in dust samples If this study is successful it will be used to plan future asthma prevention trials
Detailed Description: Evidence suggests that exposure to cockroach allergen might be the most important risk factor for asthma in inner-city households Contrary to other students in the literature we recently reported that cockroach extermination alone-without professional cleaning or occupant education-reduced cockroach allergen levels in inner-city homes This was an important finding because extermination alone would be much less expensive and easier to implement than a more comprehensive intervention The primary objective of this study is to validate our previous finding that cockroach extermination alone can significantly reduce cockroach allergen levels in inner-city homes The secondary objective is to determine the level of expertise and effort in extermination that would be required to achieve significant allergen reductions The study design will be a 3-arm randomized control trial Sixty cockroach-infested multi-unit rental homes will be randomly assigned to either a control group or one of two treatment groups The Treatment-1 group which will test the efficacy of extermination will receive insecticide bait placement by staff from the Urban Entomology Department at North Carolina State University the gold standard for this study The Treatment-2 group which will test the effectiveness of extermination will receive extermination from 1 to 5 commercial pest control companies randomly assigned to the homes Study staff will assist home occupants in obtaining a 12-month prepaid contract Periodically in all homes study staff will administer a questionnaire set cockroach traps to monitor cockroach numbers and sample dust to monitor cockroach allergen levels Treatment-1 homes will receive exterminations by NCSU staff at baseline and then as needed as determined by cockroach trap counts Treatment-2 homes will receive extermination by commercial applicators according to the terms of the contract In the NIEHS laboratory of Dr Zeldin dust samples will be analyzed for concentrations of cockroach allergens Bla g 1 and Bla g 2 Statistical analyses will compare cockroach allergen concentration changes in each of the treatment groups relative to changes in the control group The percentage of homes for which concentrations are reduced below 80 and 20 units of allergen per gram of dust-the proposed thresholds for asthma morbidity and allergic sensitization respectively-will also be compared between groups The results from this study if they prove to be consistent with our previous work will be used by NIEHS to plan future primary and secondary asthma prevention trials With the exception of NCSU staff the field and laboratory work will be carried out by staff from Dr Zeldins clinical program

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
04-E-N265 None None None