Clinical trial NCT01251224: Mouse Allergen and Asthma Intervention Trial
Official title: Mouse Allergen and Asthma Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Mouse Allergy
Mouse Allergen Exposure
Keywords: asthma
mouse allergen
environmental intervention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Columbia University
First posted: 2010-12-01
Enrollment: 361
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in asthma symptoms
timeFrame: 0, 3, 6, 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Boston Children's
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.