AsthmaPhase 3MAAITNCT01251224
Mouse Allergen and Asthma Intervention Trial
A Phase 3 study testing Integrated Pest Management and Education in people with Asthma and Mouse Allergy, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma, Mouse Allergy, Mouse Allergen Exposure
- What is being tested?
- Integrated Pest Management and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- persistent asthma
- exacerbation, previous 12 months
- evidence of mouse sensitization
- high levels of mouse allergen in home
- ages 5-17 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins
Baltimore, Maryland, 21287
Boston Children's
Boston, Massachusetts, 02210
About this study
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.
- Conditions
- Asthma, Mouse Allergy, Mouse Allergen Exposure
- Being tested
- Integrated Pest Management, Education
- Keywords
- asthma, mouse allergen, environmental intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EducationOther
This group will receive education about mouse IPM.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Active comparator | This group will receive IPM education at baseline, and then the full IPM intervention after completing the study. Receives: Other: Education |
| IPM Group | Experimental | This group will receive the full IPM intervention at baseline. Receives: Other: Integrated Pest Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in asthma symptoms
days of asthma symptoms
Measured: 0, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Columbia University
- Responsible party
- Principal investigator, Elizabeth Matsui, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251224
- Sponsor's protocol ID
- 1U01AI083238
- Acronym
- MAAIT
- Status last verified
- Mar 2017
- First submitted
- 29 Nov 2010
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31866099Ahmed 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.
PubMed 31520838Kochis 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.
PubMed 30703536Matsui 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.
PubMed 28264080
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouse Allergen and Asthma Intervention Trial
- ClinicalTrials.gov ID
- NCT01251224
- Acronym / sponsor ID
- MAAIT / 1U01AI083238
- Conditions
- Asthma, Mouse Allergy, Mouse Allergen Exposure
- Keywords
- asthma, mouse allergen, environmental intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Columbia University
- Study start
- Nov 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Active comparator | Other: EducationThis group will receive IPM education at baseline, and then the full IPM intervention after completing the study. |
| IPM Group | Experimental | Other: Integrated Pest ManagementThis group will receive the full IPM intervention at baseline. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- persistent asthma
- exacerbation, previous 12 months
- evidence of mouse sensitization
- high levels of mouse allergen in home
- ages 5-17 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Pest ManagementThe 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. | Other | IPM Group |
| EducationThis group will receive education about mouse IPM. | Other | Education Group |
Primary outcome
change in asthma symptoms
Time frame: 0, 3, 6, 9, 12 months
days of asthma symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Derived from this study: PubMed 31866099Grant 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.
- Derived from this study: PubMed 31520838Ahmed 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.
- Derived from this study: PubMed 30703536Kochis 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.
- Derived from this study: PubMed 28264080Matsui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrated Pest Management and Education in people with Asthma and Mouse Allergy, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in asthma symptoms (time frame: 0, 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251224, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.