Mouse Allergen and Asthma Intervention Trial (MAAIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Collaborators:
Children's Hospital Boston
Columbia University
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01251224
First received: November 29, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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
Asthma
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: November 2014
Estimated Primary Completion Date: November 2014 (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.

  Eligibility

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

Inclusion Criteria:

  • persistent asthma
  • exacerbation, previous 12 months
  • evidence of mouse sensitization
  • high levels of mouse allergen in home
  • ages 6-17 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 ClinicalTrials.gov identifier: NCT01251224

Locations
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michelle Newman, RN    410-502-9264    mnewma10@jhmi.edu   
Principal Investigator: Elizabeth Matsui, MD, MHS         
United States, Massachusetts
Boston Children's Recruiting
Boston, Massachusetts, United States, 02210
Contact: Amparito Cunningham       Amparito.Cunningham@childrens.harvard.edu   
Principal Investigator: Wanda Phipatanakul, MD, MS         
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
ClinicalTrials.gov Identifier: NCT01251224     History of Changes
Other Study ID Numbers: 1U01AI083238
Study First Received: November 29, 2010
Last Updated: September 19, 2013
Health Authority: Unisted States: National Institutes of Health, NIAID Safety Monitoring Committee

Keywords provided by Johns Hopkins University:
asthma
mouse allergen
environmental intervention

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014