AllergyPhase 2NCT00339690
Dust Mite Allergen Reduction Study
A Phase 2 study testing MITE-T-FASTtest kit in people with Allergy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study will determine whether use of an in-home test kit results in decreased dust mite allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite allergens come from dust mites - microscopic spider-like animals that feed on house dust. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Allergy
- What is being tested?
- MITE-T-FASTtest kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2005to 11 Feb 2009
- Phase
- Phase 2
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Live in Triangle area.
- Plan to remain in the same house for at least 12 months.
- Child in household aged 5 to 15 with allergy or sensitivity to dust mites (self-reported by parent or guardian, and a doctor's diagnosis of dust mite allergy or sensitivity is not required, i.e., if the parent or guardian believes or suspects that the child is allergic or sensitive to dust mites, that is sufficient).
- Child sleeps in own bed at least 3 nights a week.
- Child's room has carpeting on at least 50% of the floor.
- Parents do not currently have dust mite protective mattress covers on the bed.
- At least one of the two bedroom surfaces must have Group 2 dust mite allergen levels of greater than or equal to 2 microliter/g with the ELISA test AND greater than or equal to 2 microliter/g on at least one of the two Mite-T-Fast tests for inclusion.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine whether use of an in-home test kit results in decreased dust mite allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite allergens come from dust mites - microscopic spider-like animals that feed on house dust. Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are allergic to dust mite allergens and may develop asthma from living near them.
People who live in the Research Triangle Park area of North Carolina who have a child between 5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study. Participants must plan to remain in the same house for at least 12 months from the start of the study. At least half the floor of the child's room must be carpeted.
Read more
Participants are given materials on how to reduce dust mite allergens in their home. Study staff visit participants' homes three times over a 12-month period to ask questions about the home, home cleaning habits, and participants' experiences with home test kits (see below) for measuring dust mite allergen. At each visit, staff collect dust samples from the child's bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the laboratory for dust mite allergens and the results are given to the participants at the end of the study.
Participants are also given four home test kits for measuring dust mite allergen in the home. At the first home visit, staff instruct the participants on how to use the kits and answer any questions they may have. The kits are mailed at certain times during the study for the participants to use to measure allergen and send the results to the study investigators in a pre-paid addressed envelope.
A control group is given educational materials but no test kits.
Read the detailed description
Sensitization to dust mite allergens is a major risk factor for the development and exacerbation of asthma. Asthmatics and others with dust mite allergies often implement strategies to avoid dust mite exposure, but lack objective evidence that their efforts are successful in reducing dust mite populations. Recently developed in-home test kits have introduced the capability to monitor the effectiveness of allergen reduction strategies by providing an affordable, simple way to measure dust mite allergens on a regular basis. The primary objective of this study is to determine if use of an in-home test kit result in decreased dust mite allergen levels in homes of children sensitive or allergic to dust mites. A secondary objective is to determine if use of an in-home test kit result in attitudinal and/or behavioral changes related to implementing and maintaining dust mite reduction strategies.
This study is a randomized controlled intervention trial designed to test the efficacy of an in-home test kit in influencing behaviors to reduce dust mite allergen levels. Households will be recruited through flyers and screened for eligibility through a recruitment call line. Study participants will be randomly assigned to a treatment or control group. The treatment group will receive educational materials and an in-home test kit at set intervals, while the control group will receive educational materials alone.
Vacuumed dust samples will be collected and delivered to the NIEHS laboratory for ELISA-based measurements of the dust mite allergens Der f 2 and Der p 2. A questionnaire will be used to collect information on home characteristics and on dust mite reduction attitudes and behaviors. The Precaution Adoption Process Model (PAPM) will be used to assess changes in attitudes and behaviors. Data will be collected at baseline, 6-months, and 12-months.
The primary statistical analysis will measure the change in allergen concentrations from baseline to month 12. This change will be compared between the two study arms using a generalized linear model to test the null hypothesis of no difference between groups. In secondary analyses, data from each sampling location will be analyzed separately and changes from 0-to-6 and 6-to-12 months will be compared between the treatment and control groups. Data from the questionnaire and baseline home visits will be analyzed for each group to determine PAPM stages and transitions. The results from this study will be used by NIEHS to plan future primary and secondary asthma prevention trials.
- Conditions
- Allergy
- Being tested
- MITE-T-FASTtest kit
- Keywords
- Asthma, Allergy, Intervention, Behaviors, Test-Kit, Dust Mites Allergen
- Medical subject headings
- Hypersensitivity, Asthma, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITE-T-FASTtest kitOther
The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.
| Study group | Role | What they receive |
|---|---|---|
| Test Kit Homes | Experimental | Households assigned to use the in-home test kit. Receives: Other: MITE-T-FASTtest kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in the log-transformed (Der f 2 + Der p 2) allergen concentrations for the child s bed and bedroom floor.
Measured: Baseline, and months 6 and 12
Data from each of the six sampled locations (child s bed, child s bedroom floor, living room floor, parent s bed, and parent s floor) are analyzed separately, and changes are compared between the treatment and control groups.
Measured: Baseline, and months 6 and 12
Secondary outcomes (1)
Data from the questionnaire and observation form will be used toaddress the secondary study objective to determine if use of an in-home test kit results in a change in dust mite reduction attitudes and behaviors.
Measured: Baseline, and months 1, 2, 5, 6, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start6 Jun 2005
- Primary completion11 Feb 2009
- Study completion11 Feb 2009
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 AllergyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Darryl C Zeldin, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339690
- Sponsor's protocol ID
- 999905166
- Other IDs
- 05-E-N166
- Status last verified
- 27 Nov 2015
- First submitted
- 19 Jun 2006
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001 Jan;107(1):3-8. doi: 10.1067/mai.2001.112262.
PubMed 11149982Gergen PJ, Turkeltaub PC. The association of individual allergen reactivity with respiratory disease in a national sample: data from the second National Health and Nutrition Examination Survey, 1976-80 (NHANES II). J Allergy Clin Immunol. 1992 Oct;90(4 Pt 1):579-88. doi: 10.1016/0091-6749(92)90130-t.
PubMed 1401641Platts-Mills TA, Vervloet D, Thomas WR, Aalberse RC, Chapman MD. Indoor allergens and asthma: report of the Third International Workshop. J Allergy Clin Immunol. 1997 Dec;100(6 Pt 1):S2-24. doi: 10.1016/s0091-6749(97)70292-6. No abstract available.
PubMed 9438476Winn AK, Salo PM, Klein C, Sever ML, Harris SF, Johndrow D, Crockett PW, Cohn RD, Zeldin DC. Efficacy of an in-home test kit in reducing dust mite allergen levels: results of a randomized controlled pilot study. J Asthma. 2016;53(2):133-8. doi: 10.3109/02770903.2015.1072721. Epub 2015 Aug 24.
PubMed 26308287
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dust Mite Allergen Reduction Study
- ClinicalTrials.gov ID
- NCT00339690
- Acronym / sponsor ID
- 999905166
- Conditions
- Allergy
- Keywords
- Asthma, Allergy, Intervention, Behaviors, Test-Kit, Dust Mites Allergen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 6 Jun 2005
- Primary completion
- 11 Feb 2009 (actual)
- Study completion
- 11 Feb 2009 (actual)
- First posted
- 21 Jun 2006 (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.
This study will determine whether use of an in-home test kit results in decreased dust mite allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite allergens come from dust mites - microscopic spider-like animals that feed on house dust. Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are allergic to dust mite allergens and may develop asthma from living near them.
People who live in the Research Triangle Park area of North Carolina who have a child between 5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study. Participants must plan to remain in the same house for at least 12 months from the start of the study. At least half the floor of the child's room must be carpeted.
Participants are given materials on how to reduce dust mite allergens in their home. Study staff visit participants' homes three times over a 12-month period to ask questions about the home, home cleaning habits, and participants' experiences with home test kits (see below) for measuring dust mite allergen. At each visit, staff collect dust samples from the child's bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the laboratory for dust mite allergens and the results are given to the participants at the end of the study.
Participants are also given four home test kits for measuring dust mite allergen in the home. At the first home visit, staff instruct the participants on how to use the kits and answer any questions they may have. The kits are mailed at certain times during the study for the participants to use to measure allergen and send the results to the study investigators in a pre-paid addressed envelope.
A control group is given educational materials but no test kits.
Detailed description
Sensitization to dust mite allergens is a major risk factor for the development and exacerbation of asthma. Asthmatics and others with dust mite allergies often implement strategies to avoid dust mite exposure, but lack objective evidence that their efforts are successful in reducing dust mite populations. Recently developed in-home test kits have introduced the capability to monitor the effectiveness of allergen reduction strategies by providing an affordable, simple way to measure dust mite allergens on a regular basis. The primary objective of this study is to determine if use of an in-home test kit result in decreased dust mite allergen levels in homes of children sensitive or allergic to dust mites. A secondary objective is to determine if use of an in-home test kit result in attitudinal and/or behavioral changes related to implementing and maintaining dust mite reduction strategies.
This study is a randomized controlled intervention trial designed to test the efficacy of an in-home test kit in influencing behaviors to reduce dust mite allergen levels. Households will be recruited through flyers and screened for eligibility through a recruitment call line. Study participants will be randomly assigned to a treatment or control group. The treatment group will receive educational materials and an in-home test kit at set intervals, while the control group will receive educational materials alone.
Vacuumed dust samples will be collected and delivered to the NIEHS laboratory for ELISA-based measurements of the dust mite allergens Der f 2 and Der p 2. A questionnaire will be used to collect information on home characteristics and on dust mite reduction attitudes and behaviors. The Precaution Adoption Process Model (PAPM) will be used to assess changes in attitudes and behaviors. Data will be collected at baseline, 6-months, and 12-months.
The primary statistical analysis will measure the change in allergen concentrations from baseline to month 12. This change will be compared between the two study arms using a generalized linear model to test the null hypothesis of no difference between groups. In secondary analyses, data from each sampling location will be analyzed separately and changes from 0-to-6 and 6-to-12 months will be compared between the treatment and control groups. Data from the questionnaire and baseline home visits will be analyzed for each group to determine PAPM stages and transitions. The results from this study will be used by NIEHS to plan future primary and secondary asthma prevention trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Kit Homes | Experimental | Other: MITE-T-FASTtest kitHouseholds assigned to use the in-home test kit. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Live in Triangle area.
- Plan to remain in the same house for at least 12 months.
- Child in household aged 5 to 15 with allergy or sensitivity to dust mites (self-reported by parent or guardian, and a doctor's diagnosis of dust mite allergy or sensitivity is not required, i.e., if the parent or guardian believes or suspects that the child is allergic or sensitive to dust mites, that is sufficient).
- Child sleeps in own bed at least 3 nights a week.
- Child's room has carpeting on at least 50% of the floor.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
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 |
|---|---|---|
| MITE-T-FASTtest kitThe primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone. | Other | Test Kit Homes |
Primary outcome
The primary outcome is the change in the log-transformed (Der f 2 + Der p 2) allergen concentrations for the child s bed and bedroom floor.
Time frame: Baseline, and months 6 and 12
Data from each of the six sampled locations (child s bed, child s bedroom floor, living room floor, parent s bed, and parent s floor) are analyzed separately, and changes are compared between the treatment and control groups.
Time frame: Baseline, and months 6 and 12
1 secondary outcome
Data from the questionnaire and observation form will be used toaddress the secondary study objective to determine if use of an in-home test kit results in a change in dust mite reduction attitudes and behaviors.
Time frame: Baseline, and months 1, 2, 5, 6, 8, and 12
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 Dec 2019.
- Background: PubMed 11149982Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001 Jan;107(1):3-8. doi: 10.1067/mai.2001.112262.
- Background: PubMed 1401641Gergen PJ, Turkeltaub PC. The association of individual allergen reactivity with respiratory disease in a national sample: data from the second National Health and Nutrition Examination Survey, 1976-80 (NHANES II). J Allergy Clin Immunol. 1992 Oct;90(4 Pt 1):579-88. doi: 10.1016/0091-6749(92)90130-t.
- Background: PubMed 9438476Platts-Mills TA, Vervloet D, Thomas WR, Aalberse RC, Chapman MD. Indoor allergens and asthma: report of the Third International Workshop. J Allergy Clin Immunol. 1997 Dec;100(6 Pt 1):S2-24. doi: 10.1016/s0091-6749(97)70292-6. No abstract available.
- Derived from this study: PubMed 26308287Winn AK, Salo PM, Klein C, Sever ML, Harris SF, Johndrow D, Crockett PW, Cohn RD, Zeldin DC. Efficacy of an in-home test kit in reducing dust mite allergen levels: results of a randomized controlled pilot study. J Asthma. 2016;53(2):133-8. doi: 10.3109/02770903.2015.1072721. Epub 2015 Aug 24.
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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.
Darryl C Zeldin, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MITE-T-FASTtest kit in people with Allergy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site 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 7 inclusion and 1 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome is the change in the log-transformed (Der f 2 + Der p 2) allergen concentrations for the child s bed and bedroom floor. (time frame: Baseline, and months 6 and 12). The study lists 2 primary outcomes in all. 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 NCT00339690, 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 Dec 2019.