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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005523
Other study ID # 5050
Secondary ID R18HL058942
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date August 1998
Est. completion date December 2003

Study information

Verified date January 2006
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 conduct a randomized trial in asthmatic children to compare the effectiveness of a home-based allergen control program with a customary educational program delivered in offices


Description:

DESIGN NARRATIVE:

Two-hundred-forty children, 6 to 17 years of age, were recruited to participate in the study. Following the collection of baseline data, all families in the study received standard environmental control education prior to randomization to the control or experimental group. This education provided parents and children with information about such topics as the child's sensitivity profile, the relationship between exposure to allergens and asthma, and the risks of passive smoking. All families were given information on how to receive environmental control aids and services available by mail at no or reduced costs.

Once families were randomized, those in the control group received no additional intervention. Those in the experimental group received a home-based allergen control intervention delivered by trained environmental counselors. Primary outcomes were changes in asthma-related quality of life and changes in targeted allergen levels in the home. Secondary outcome measures included self-efficacy for environmental allergy control, FEV1, and parent-reported health care utilization.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Eggleston PA, Butz A, Rand C, Curtin-Brosnan J, Kanchanaraksa S, Swartz L, Breysse P, Buckley T, Diette G, Merriman B, Krishnan JA. Home environmental intervention in inner-city asthma: a randomized controlled clinical trial. Ann Allergy Asthma Immunol. 2005 Dec;95(6):518-24. — View Citation

Eggleston PA. Control of environmental allergens as a therapeutic approach. Immunol Allergy Clin North Am. 2003 Aug;23(3):533-47, viii-ix. Review. — View Citation

Eggleston PA. Environmental causes of asthma in inner city children. The National Cooperative Inner City Asthma Study. Clin Rev Allergy Immunol. 2000 Jun;18(3):311-24. Review. — View Citation

Matsui EC, Wood RA, Rand C, Kanchanaraksa S, Swartz L, Curtin-Brosnan J, Eggleston PA. Cockroach allergen exposure and sensitization in suburban middle-class children with asthma. J Allergy Clin Immunol. 2003 Jul;112(1):87-92. — View Citation

Matsui EC, Wood RA, Rand C, Kanchanaraksa S, Swartz L, Eggleston PA. Mouse allergen exposure and mouse skin test sensitivity in suburban, middle-class children with asthma. J Allergy Clin Immunol. 2004 May;113(5):910-5. — View Citation

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