HypersensitivityNCT00344344
A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes
An observational study of Hypersensitivity, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2000to 11 Sep 2006
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the study, each home must:
- have a home occupant who intends to live at the same address for at least 6 months;
- have a home occupant live at the house full time;
- have a home occupant that is at least 21 years of age;
- have at least one bedroom with wall to wall carpeting.
- Yield dust collected during the screening visit that contains combined Der f I plus Der p I allergen levels of greater than or equal to 10 ug/gram dust.
- For the intervention arm only:
- home occupant must have an adult at home during the study visits on weekdays over the six month period that the study is ongoing.
Who cannot join
- Homes will be excluded from this study if any of the inclusion criteria are not met.
- Indoor Dust Mite Allergen:
- Must have a home occupant who intends to live at the same address for at least 6 months; live at the house full time; be at least 21 years of age; have at least one bedroom with wall to wall carpeting; yield dust collected during the screening visit that contains combined Def fl plus Der pl allergen levels of greater than or equal to 10 ug/gram dust.
- For Intervention arm only - home occupant must have an adult at home during the study visits on weekdays over the six month period that the study is ongoing.
- Indoor Cockroach Allergen:
- Must have a home occupant that intends to live at the same address for at least 6 months; live in the house full time; be at least 21 years of age; have moderate to severe cockroach infestation as evidenced by occupant self-reports of cockroach sightings and by sticky trap assessment that yield a combined total sticky trap count of 50-250 cockroaches.
- For intervention arm only - home occupant must have an adult at home during most of the weekdays over the six month period that the study is ongoing.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Environmental Health Sciences (NIEHS)
Bethesda, Maryland, 20892
About this study
A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes
Read the detailed description
We propose to conduct a study to evaluate the efficacy of an intensive cockroach and cockroach allergen removal program to mitigate cockroach allergen levels in house dust to less than 8 Units Bla g1 allergen protein per gram vacuumed dust in kitchen and TV/family room samples and less than 2 Units Bla g1 per gram vacuumed dust in bedroom samples. In addition, we propose to test the effectiveness of a method of combined dry steam cleaning in conjunction with Capture (Trademark) carpet cleaning for mitigation of dust mite allergens in bedroom carpeting.
Candidate housing units for cockroach allergen mitigation will be identified through ongoing entomology research projects conducted as part of project NC06405 of the North Carolina Agricultural Research Service, entitled Insect-Specific Target Systems for the Development of Novel Tools for Cockroach Control. This project is directed by Dr. Coby Schal, Department of Entomology at North Carolina State University. Prior to enrollment of homes in the allergen intervention study, up to 10 cockroach infested homes will be sampled only (no intervention) using vacuum and swab sampling procedures described in the intervention study protocol. These visits will be coordinated to coincide with home visits associated with project NC06405 and will not involve intervention or data collection other than dust sample collection. Documentation of cockroach infestations in sampled homes will be accomplished through review of infestation data collected as part of project NC06405 activities. The purpose of these sampling-only visits will be to test and refine sample collection methods, to train study staff on sample collection methodologies, and to confirm the heterogeneity of cockroach allergen distribution within cockroach infested dwellings prior to initiation of the intervention study.
For the intervention study, homes with a past history of cockroach infestation will be contacted. Residents of candidate study homes will be contacted by telephone, provided with a brief overview of the study and interviewed to determine if their home qualifies for participation. The telephone interview will focus on occupant assessments of cockroach infestation levels, history and related topics. Homes that appear to have moderate infestation based on telephone screening information will be scheduled for a Screening Visit. During the Screening Visit, after administration of an informed consent form to a single adult home resident, a home environmental questionnaire will be administered and home environmental observations will be made. In addition, adhesive tape (sticky) traps will be placed for assessment of infestation levels and hand-drawn room layout maps will be constructed documenting sticky trap locations. Approximately 3 days after sticky trap placement, a Baseline visit will be conducted to assess sticky trapping results. If sufficient insects have been trapped, vacuum samples and swab samples will be collected in each of three study rooms for allergen analysis (kitchen, TV/family room, one bedroom. As soon as possible after Baseline sampling is completed, a home will be scheduled for an initial intervention visit, comprised of a general cleaning, occupant education on general principals of integrated pest management. An initial extermination effort will be applied as soon as possible after completion of the general home cleaning and an initial targeted cleaning, focused on areas of high allergen concentration as determined by swab sampling results, will occur within 10-15 days of the extermination. At 1, 2, and 4 month points after the initial targeting cleaning, sticky trapping will be performed to confirm the effectiveness of the extermination, both vacuum and swab sampling will be repeated, a brief occupant follow-up questions will be administered and occupant education will be enforced. Based upon the results of sticky trappings, extermination efforts may be repeated. Targeted cleaning will be conducted if any follow-up swab or vacuum samples contain detectable Bla g1 allergen. Six month follow-up visits will also be conducted and will be identical to the 1, 2 and 4 month visits except that they will not include repeated extermination, targeted cleaning activities or occupant education. Recruitment will continue until 16 homes have been enrolled into the cockroach intervention arm of the study, with a goal of completion of at least 12 homes in North Carolina through 6 month follow-up visit. Up to 5 multi-unit dwellings will be enrolled from the inner city Boston, Massachusetts area in order to test this mitigation strategy in inner-city, multiunit dwellings in the Northeastern U.S.
Candidate dust mite intervention homes will be recruited through local advertisements and person to person communication to identify and enroll 8 homes with bedroom carpet dust that contains combined levels of Der f1 and Der p1 of > 10 ug/gram vacuumed dust. Intervention will be applied in a single bedroom and will consist of installation of impermeable bedding covers, occupant education, and carpet steam cleaning followed by Capture (Trademark) cleaning of carpeting. Follow-up vacuumed dust sampling will occur at 1, 2, 4, and 6 month time points and will be immediately followed by repeated steam cleaning followed by Capture (trademark) cleaning at the 1, 2, and 4 month time points. Completion of 6 homes through the 6 month follow-up visit is projected. Only local North Carolina homes will be enrolled into the dust mite allergen intervention.
- Conditions
- Hypersensitivity
- Keywords
- Asthma, Cockroach, Dust Mite, Extermination, Targeted Cleaning, Allergy, Prevention
- Medical subject headings
- Hypersensitivity, Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start19 Oct 2000
- Study completion11 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies 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
- Observational
- Enrolment
- 88 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344344
- Sponsor's protocol ID
- 999901016
- Other IDs
- 01-E-N016
- Status last verified
- 11 Sep 2006
- First submitted
- 23 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes
- ClinicalTrials.gov ID
- NCT00344344
- Acronym / sponsor ID
- 999901016
- Conditions
- Hypersensitivity
- Keywords
- Asthma, Cockroach, Dust Mite, Extermination, Targeted Cleaning, Allergy, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 19 Oct 2000
- Study completion
- 11 Sep 2006
- First posted
- 26 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.
A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes
Detailed description
We propose to conduct a study to evaluate the efficacy of an intensive cockroach and cockroach allergen removal program to mitigate cockroach allergen levels in house dust to less than 8 Units Bla g1 allergen protein per gram vacuumed dust in kitchen and TV/family room samples and less than 2 Units Bla g1 per gram vacuumed dust in bedroom samples. In addition, we propose to test the effectiveness of a method of combined dry steam cleaning in conjunction with Capture (Trademark) carpet cleaning for mitigation of dust mite allergens in bedroom carpeting.
Candidate housing units for cockroach allergen mitigation will be identified through ongoing entomology research projects conducted as part of project NC06405 of the North Carolina Agricultural Research Service, entitled Insect-Specific Target Systems for the Development of Novel Tools for Cockroach Control. This project is directed by Dr. Coby Schal, Department of Entomology at North Carolina State University. Prior to enrollment of homes in the allergen intervention study, up to 10 cockroach infested homes will be sampled only (no intervention) using vacuum and swab sampling procedures described in the intervention study protocol. These visits will be coordinated to coincide with home visits associated with project NC06405 and will not involve intervention or data collection other than dust sample collection. Documentation of cockroach infestations in sampled homes will be accomplished through review of infestation data collected as part of project NC06405 activities. The purpose of these sampling-only visits will be to test and refine sample collection methods, to train study staff on sample collection methodologies, and to confirm the heterogeneity of cockroach allergen distribution within cockroach infested dwellings prior to initiation of the intervention study.
For the intervention study, homes with a past history of cockroach infestation will be contacted. Residents of candidate study homes will be contacted by telephone, provided with a brief overview of the study and interviewed to determine if their home qualifies for participation. The telephone interview will focus on occupant assessments of cockroach infestation levels, history and related topics. Homes that appear to have moderate infestation based on telephone screening information will be scheduled for a Screening Visit. During the Screening Visit, after administration of an informed consent form to a single adult home resident, a home environmental questionnaire will be administered and home environmental observations will be made. In addition, adhesive tape (sticky) traps will be placed for assessment of infestation levels and hand-drawn room layout maps will be constructed documenting sticky trap locations. Approximately 3 days after sticky trap placement, a Baseline visit will be conducted to assess sticky trapping results. If sufficient insects have been trapped, vacuum samples and swab samples will be collected in each of three study rooms for allergen analysis (kitchen, TV/family room, one bedroom. As soon as possible after Baseline sampling is completed, a home will be scheduled for an initial intervention visit, comprised of a general cleaning, occupant education on general principals of integrated pest management. An initial extermination effort will be applied as soon as possible after completion of the general home cleaning and an initial targeted cleaning, focused on areas of high allergen concentration as determined by swab sampling results, will occur within 10-15 days of the extermination. At 1, 2, and 4 month points after the initial targeting cleaning, sticky trapping will be performed to confirm the effectiveness of the extermination, both vacuum and swab sampling will be repeated, a brief occupant follow-up questions will be administered and occupant education will be enforced. Based upon the results of sticky trappings, extermination efforts may be repeated. Targeted cleaning will be conducted if any follow-up swab or vacuum samples contain detectable Bla g1 allergen. Six month follow-up visits will also be conducted and will be identical to the 1, 2 and 4 month visits except that they will not include repeated extermination, targeted cleaning activities or occupant education. Recruitment will continue until 16 homes have been enrolled into the cockroach intervention arm of the study, with a goal of completion of at least 12 homes in North Carolina through 6 month follow-up visit. Up to 5 multi-unit dwellings will be enrolled from the inner city Boston, Massachusetts area in order to test this mitigation strategy in inner-city, multiunit dwellings in the Northeastern U.S.
Candidate dust mite intervention homes will be recruited through local advertisements and person to person communication to identify and enroll 8 homes with bedroom carpet dust that contains combined levels of Der f1 and Der p1 of > 10 ug/gram vacuumed dust. Intervention will be applied in a single bedroom and will consist of installation of impermeable bedding covers, occupant education, and carpet steam cleaning followed by Capture (Trademark) cleaning of carpeting. Follow-up vacuumed dust sampling will occur at 1, 2, 4, and 6 month time points and will be immediately followed by repeated steam cleaning followed by Capture (trademark) cleaning at the 1, 2, and 4 month time points. Completion of 6 homes through the 6 month follow-up visit is projected. Only local North Carolina homes will be enrolled into the dust mite allergen intervention.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have a home occupant who intends to live at the same address for at least 6 months;
- have a home occupant live at the house full time;
- have a home occupant that is at least 21 years of age;
- have at least one bedroom with wall to wall carpeting.
- Yield dust collected during the screening visit that contains combined Der f I plus Der p I allergen levels of greater than or equal to 10 ug/gram dust.
Key exclusion criteria (7 listed)
- Homes will be excluded from this study if any of the inclusion criteria are not met.
- Must have a home occupant who intends to live at the same address for at least 6 months; live at the house full time; be at least 21 years of age; have at least one bedroom with wall to wall carpeting; yield dust collected during the screening visit that contains combined Def fl plus Der pl allergen levels of greater than or equal to 10 ug/gram dust.
- For Intervention arm only - home occupant must have an adult at home during the study visits on weekdays over the six month period that the study is ongoing.
- Must have a home occupant that intends to live at the same address for at least 6 months; live in the house full time; be at least 21 years of age; have moderate to severe cockroach infestation as evidenced by occupant self-reports of cockroach sightings and by sticky trap assessment that yield a combined total sticky trap count of 50-250 cockroaches.
- For intervention arm only - home occupant must have an adult at home during most of the weekdays over the six month period that the study is ongoing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, 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 8 inclusion and 7 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 2 Jul 2017. 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.
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.
Where can I read the original study information?
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 2 Jul 2017.