Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mouse Allergen and Asthma Intervention Trial (MAAIT)

This study is ongoing, but not recruiting participants.
Children's Hospital Boston
Columbia University
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University Identifier:
First received: November 29, 2010
Last updated: September 12, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Mouse Allergy
Mouse Allergen Exposure
Other: Integrated Pest Management
Other: Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mouse Allergen and Asthma Intervention Trial

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in asthma symptoms [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    days of asthma symptoms

Estimated Enrollment: 350
Study Start Date: November 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Education Group
This group will receive IPM education at baseline, and then the full IPM intervention after completing the study.
Other: Education
This group will receive education about mouse IPM.
Experimental: IPM Group
This group will receive the full IPM intervention at baseline.
Other: 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.


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01251224

United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's
Boston, Massachusetts, United States, 02210
Sponsors and Collaborators
Johns Hopkins University
Children's Hospital Boston
Columbia University
  More Information

No publications provided

Responsible Party: Elizabeth Matsui, Associate Professor, Johns Hopkins University Identifier: NCT01251224     History of Changes
Other Study ID Numbers: 1U01AI083238
Study First Received: November 29, 2010
Last Updated: September 12, 2014
Health Authority: Unisted States: National Institutes of Health, NIAID Safety Monitoring Committee

Keywords provided by Johns Hopkins University:
mouse allergen
environmental intervention processed this record on March 03, 2015