Mouse Allergen and Asthma Intervention Trial

NCT ID: NCT01251224

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-09-30

Brief Summary

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The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen exposure in mouse allergic children with asthma and mouse allergen exposure. Participants will be randomized to either the Integrated Pest Management (IPM) Group or the Education Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters, allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group will receive education about IPM at the beginning of the trial and then after completion of the trial, will receive the IPM intervention. Participants will be followed for 12 months.

Detailed Description

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Conditions

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Asthma Mouse Allergy Mouse Allergen Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Education Group

This group will receive IPM education at baseline, and then the full IPM intervention after completing the study.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

This group will receive education about mouse IPM.

IPM Group

This group will receive the full IPM intervention at baseline.

Group Type EXPERIMENTAL

Integrated Pest Management

Intervention Type OTHER

The IPM intervention will include professional mouse abatement, two HEPA filters, targeted cleaning, education about IPM, and allergen-proof mattress and pillow encasements. The intervention will be delivered at baseline to the IPM Group, and then repeated if recurrent or persistent mouse infestation is present.

Interventions

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Integrated Pest Management

The IPM intervention will include professional mouse abatement, two HEPA filters, targeted cleaning, education about IPM, and allergen-proof mattress and pillow encasements. The intervention will be delivered at baseline to the IPM Group, and then repeated if recurrent or persistent mouse infestation is present.

Intervention Type OTHER

Education

This group will receive education about mouse IPM.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* persistent asthma
* exacerbation, previous 12 months
* evidence of mouse sensitization
* high levels of mouse allergen in home
* ages 5-17 years

Exclusion Criteria

* intermittent asthma
* no exacerbation in previous 12 months
* not sensitized to mouse
* low or undetectable mouse allergen in home
* other lung disease aside from asthma
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Matsui

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johns Hopkins

Baltimore, Maryland, United States

Site Status

Boston Children's

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Grant T, Phipatanakul W, Perzanowski M, Balcer-Whaley S, Peng RD, Curtin-Brosnan J, Newman M, Cunningham A, Divjan A, Bollinger ME, Wise RA, Matsui EC. Reduction in mouse allergen exposure is associated with greater lung function growth. J Allergy Clin Immunol. 2020 Feb;145(2):646-653.e1. doi: 10.1016/j.jaci.2019.08.043. Epub 2019 Dec 19.

Reference Type DERIVED
PMID: 31866099 (View on PubMed)

Ahmed A, Sadreameli SC, Curtin-Brosnan J, Grant T, Phipatanakul W, Perzanowski M, Balcer-Whaley S, Peng R, Newman M, Cunningham A, Divjan A, Bollinger ME, Wise RA, Miller R, Chew G, Matsui EC. Do Baseline Asthma and Allergic Sensitization Characteristics Predict Responsiveness to Mouse Allergen Reduction? J Allergy Clin Immunol Pract. 2020 Feb;8(2):596-602.e3. doi: 10.1016/j.jaip.2019.08.044. Epub 2019 Sep 11.

Reference Type DERIVED
PMID: 31520838 (View on PubMed)

Kochis SR, Grant T, Phipatanakul W, Perzanowski M, Balcer-Whaley S, Curtin-Brosnan J, Newman M, Cunningham A, Bollinger ME, Matsui EC. Caregiver-Reported Asthma Control Predicts Future Visits, Independent of Guideline-Based Control Measures. J Allergy Clin Immunol Pract. 2019 May-Jun;7(5):1516-1521.e1. doi: 10.1016/j.jaip.2018.12.030. Epub 2019 Jan 28.

Reference Type DERIVED
PMID: 30703536 (View on PubMed)

Matsui EC, Perzanowski M, Peng RD, Wise RA, Balcer-Whaley S, Newman M, Cunningham A, Divjan A, Bollinger ME, Zhai S, Chew G, Miller RL, Phipatanakul W. Effect of an Integrated Pest Management Intervention on Asthma Symptoms Among Mouse-Sensitized Children and Adolescents With Asthma: A Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1027-1036. doi: 10.1001/jama.2016.21048.

Reference Type DERIVED
PMID: 28264080 (View on PubMed)

Other Identifiers

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1U01AI083238

Identifier Type: NIH

Identifier Source: org_study_id

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