Dust Mite Allergen Reduction Study

NCT00339690 | Completed Phase 2

• 2 other identifiers: 99990516605-E-N166
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether use of an in-home test kit results in decreased dust mite allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite allergens come from dust mites - microscopic spider-like animals that feed on house dust. Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are allergic to dust mite allergens and may develop asthma from living near them. People who live in the Research Triangle Park area of North Carolina who have a child between 5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study. Participants must plan to remain in the same house for at least 12 months from the start of the study. At least half the floor of the child's room must be carpeted. Participants are given materials on how to reduce dust mite allergens in their home. Study staff visit participants' homes three times over a 12-month period to ask questions about the home, home cleaning habits, and participants' experiences with home test kits (see below) for measuring dust mite allergen. At each visit, staff collect dust samples from the child's bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the laboratory for dust mite allergens and the results are given to the participants at the end of the study. Participants are also given four home test kits for measuring dust mite allergen in the home. At the first home visit, staff instruct the participants on how to use the kits and answer any questions they may have. The kits are mailed at certain times during the study for the participants to use to measure allergen and send the results to the study investigators in a pre-paid addressed envelope. A control group is given educational materials but no test kits.

Conditions

Allergy

Keywords

Asthma; Allergy; Intervention; Behaviors; Test-Kit; Dust Mites Allergen

Outcome Measures

Primary Outcomes (2)

• The primary outcome is the change in the log-transformed (Der f 2 + Der p 2) allergen concentrations for the child s bed and bedroom floor.

  Baseline, and months 6 and 12

• Data from each of the six sampled locations (child s bed, child s bedroom floor, living room floor, parent s bed, and parent s floor) are analyzed separately, and changes are compared between the treatment and control groups.

  Baseline, and months 6 and 12

Secondary Outcomes (1)

• Data from the questionnaire and observation form will be used toaddress the secondary study objective to determine if use of an in-home test kit results in a change in dust mite reduction attitudes and behaviors.

  Baseline, and months 1, 2, 5, 6, 8, and 12

Study Arms (1)

Test Kit Homes

EXPERIMENTAL

Households assigned to use the in-home test kit.

Other: MITE-T-FASTtest kit

Interventions

MITE-T-FASTtest kit OTHER

The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.

Test Kit Homes

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Live in Triangle area.
• Plan to remain in the same house for at least 12 months.
• Child in household aged 5 to 15 with allergy or sensitivity to dust mites (self-reported by parent or guardian, and a doctor's diagnosis of dust mite allergy or sensitivity is not required, i.e., if the parent or guardian believes or suspects that the child is allergic or sensitive to dust mites, that is sufficient).
• Child sleeps in own bed at least 3 nights a week.
• Child's room has carpeting on at least 50% of the floor.
• Parents do not currently have dust mite protective mattress covers on the bed.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Constella Group, Inc.

Durham, North Carolina, United States

Location

Related Publications (4)

• Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001 Jan;107(1):3-8. doi: 10.1067/mai.2001.112262.

  PMID: 11149982 BACKGROUND

• Gergen PJ, Turkeltaub PC. The association of individual allergen reactivity with respiratory disease in a national sample: data from the second National Health and Nutrition Examination Survey, 1976-80 (NHANES II). J Allergy Clin Immunol. 1992 Oct;90(4 Pt 1):579-88. doi: 10.1016/0091-6749(92)90130-t.

  PMID: 1401641 BACKGROUND

• Platts-Mills TA, Vervloet D, Thomas WR, Aalberse RC, Chapman MD. Indoor allergens and asthma: report of the Third International Workshop. J Allergy Clin Immunol. 1997 Dec;100(6 Pt 1):S2-24. doi: 10.1016/s0091-6749(97)70292-6. No abstract available.

  PMID: 9438476 BACKGROUND

• Winn AK, Salo PM, Klein C, Sever ML, Harris SF, Johndrow D, Crockett PW, Cohn RD, Zeldin DC. Efficacy of an in-home test kit in reducing dust mite allergen levels: results of a randomized controlled pilot study. J Asthma. 2016;53(2):133-8. doi: 10.3109/02770903.2015.1072721. Epub 2015 Aug 24.

  PMID: 26308287 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Asthma; Behavior

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Darryl C Zeldin, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 6, 2005
• Primary Completion: February 11, 2009
• Study Completion: February 11, 2009
• Last Updated: December 16, 2019

Record last verified: 2015-11-27

Locations

US (1)