NCT01251224

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

5.8 years

First QC Date

November 29, 2010

Last Update Submit

March 15, 2017

Conditions

AsthmaMouse AllergyMouse Allergen Exposure

Keywords

asthmamouse allergenenvironmental intervention

Outcome Measures

Primary Outcomes (1)

  • change in asthma symptoms

    days of asthma symptoms

    0, 3, 6, 9, 12 months

Study Arms (2)

Education Group

ACTIVE COMPARATOR

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

Other: Education

IPM Group

EXPERIMENTAL

This group will receive the full IPM intervention at baseline.

Other: Integrated Pest Management

Interventions

Integrated Pest ManagementOTHER

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.

IPM Group
EducationOTHER

This group will receive education about mouse IPM.

Education Group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Boston Children's

Boston, Massachusetts, 02210, United States

Location

Related Publications (4)

  • 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.

    PMID: 31866099DERIVED

  • 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.

    PMID: 31520838DERIVED

  • 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.

    PMID: 30703536DERIVED

  • 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.

    PMID: 28264080DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 1, 2010

Study Start

November 1, 2010

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 16, 2017

Record last verified: 2017-03

Locations

US(2)