Cockroach Reduction Intervention for Childhood Asthma

(ARCHS Trial)

Overseen By Joanna Baisier

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Must be taking: Long-term asthma controllers

Must not be taking: Beta-blockers

Disqualifiers: Chronic respiratory infections, Cardiovascular disease, Smoker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

290 Participants Needed

Trial Summary

What is the purpose of this trial?

The Allergen Reduction and Child Health Study (ARCHS) is a 12-month, two group randomized control trial of children with asthma and who are exposed to cockroaches. Children ages 5 - 17 living in the Greater New Orleans area will be recruited from a variety of clinic and community settings. The overall goal of the study is to improve patient-centered asthma outcomes (asthma symptom days, health care utilization, asthma control and quality of life) by targeting one key allergen - cockroach exposure in the child's home. The investigators propose a simple intervention of insecticidal bait that is low cost, simple to implement, and which is lower toxicity than other forms of pest control. The reduction in the number of cockroaches in the home is an environmental outcome that is patient-centered and is likely to add to its acceptance by families of children with asthma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that children with asthma who are on long-term controller medication are eligible to participate, so it seems likely that continuing asthma medication is allowed.

What data supports the effectiveness of the treatment for reducing cockroach exposure in children with asthma?

Research shows that using a combination of education, insecticide bait, and professional cleaning can significantly reduce cockroach numbers and allergens in homes, which are known triggers for asthma in children. Additionally, tailored pest management approaches have been successful in reducing cockroach infestations in urban communities, making them a cost-effective solution. ^{1 2 3 4 5}

Is the cockroach reduction intervention safe for humans?

The studies focus on reducing cockroach allergens to help with asthma, but they do not provide specific safety data for humans regarding the intervention methods like insecticidal bait or pest control bait. ^{1 2 3 6 7}

How does the Cockroach Reduction Intervention for Childhood Asthma treatment differ from other treatments for asthma?

This treatment is unique because it focuses on reducing cockroach exposure, a known asthma trigger, through a tailored approach or insecticidal bait, rather than directly treating asthma symptoms. Unlike standard asthma treatments that often involve medication to manage symptoms, this intervention aims to address an environmental cause of asthma. ^{3 7 8 9 10}

Research Team

Felicia Rabito, PhD

Principal Investigator

Tulane University School of Public Health and Tropical Medicine

Eligibility Criteria

The ARCHS trial is for children aged 5-17 in the Greater New Orleans area with uncontrolled persistent asthma and exposure to cockroaches. They must have had recent hospital visits or symptoms due to asthma, sleep at the target home most of the week, and speak English or Spanish. Kids can't join if they smoke, take beta-blockers, have certain heart diseases (except hypertension), other serious illnesses requiring daily meds, are on immunotherapy, or plan to move soon.

Inclusion Criteria

I have asthma and need daily medication or have frequent symptoms.

The child needs to sleep at least 4 nights per week at the specified home on average.

You have seen or caught cockroaches in your home recently.

Exclusion Criteria

I take daily medication for a heart condition, not including high blood pressure.

I am currently taking a beta-blocker medication.

You are currently smoking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment of asthma symptoms, quality of life, and cockroach exposure

1 week

1 visit (in-person)

Treatment

Participants receive either a multi-component intervention or insecticidal bait for cockroach reduction

12 months

Monthly home visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Comparator 1 (tailored approach)
• Comparator 2 (insecticidal bait)

Trial Overview This study tests two ways to reduce cockroach allergens in homes of asthmatic kids: one group uses insecticidal bait while another follows a tailored approach. The goal is to see which method better improves asthma-related health outcomes like symptom days, control over asthma, healthcare use and overall quality of life over a year.

Participant Groups

Group I: Comparator 1 (tailored approach) Active Control 1 Intervention

Multi-component intervention tailored to the participant's allergic profile.

Group II: Comparator 2 (insecticidal bait) Active Control 1 Intervention

Insecticidal bait for cockroach reduction.

Comparator 1 (tailored approach) is already approved in United States for the following indications:

Approved in United States as Environmental Intervention for:

• Asthma Management
• Allergy Prevention

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The initial combined intervention of occupant education, insecticide bait application, and professional cleaning effectively reduced cockroach allergen levels in homes, and this study found that continued insecticide application alone maintained these reductions over 12 months.

In a surprising outcome, insecticide application alone significantly decreased cockroach allergen concentrations in control homes, suggesting that ongoing pest control measures can be effective even without the initial comprehensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abatement of cockroach allergens (Bla g 1 and Bla g 2) in low-income, urban housing: month 12 continuation results. Arbes, SJ., Sever, M., Mehta, J., et al.[2010]

A residential intervention in 39 public housing apartments led to a significant reduction in cockroach allergens, with kitchen concentrations of Bla g 1 decreasing by 71% and bed concentrations by 53% after 6 months.

The most significant reductions were observed in apartments with initially higher allergen levels, indicating that intensive pest management is particularly effective in poorer housing conditions, but ongoing efforts are necessary to maintain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of integrated pest management in reducing cockroach allergen concentrations in urban public housing. Peters, JL., Levy, JI., Muilenberg, ML., et al.[2021]

In a 12-month study involving 102 children with moderate to severe asthma, the use of insecticidal bait significantly reduced cockroach counts in homes, leading to a mean change of 13.14 fewer cockroaches compared to control homes.

Children living in homes treated with insecticidal bait experienced fewer asthma symptoms and less need for unscheduled healthcare, indicating that this low-cost and low-toxicity intervention can effectively improve asthma outcomes compared to homes without the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single intervention for cockroach control reduces cockroach exposure and asthma morbidity in children. Rabito, FA., Carlson, JC., He, H., et al.[2022]

A study involving 31 homes (16 intervention and 15 control) demonstrated that a combination of occupant education, insecticide bait, and professional cleaning significantly reduced cockroach allergen levels, achieving up to a 96% reduction in kitchens and 84% in bedrooms.

The intervention successfully lowered allergen concentrations below the thresholds for allergic sensitization and asthma morbidity in most areas, indicating a promising approach for reducing asthma risk in low-income urban households.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abatement of cockroach allergen (Bla g 1) in low-income, urban housing: A randomized controlled trial. Arbes, SJ., Sever, M., Archer, J., et al.[2021]

A study involving 131 families in East Harlem showed that an individually tailored Integrated Pest Management (IPM) approach significantly reduced cockroach infestations from 80.5% to 39.0% over 6 months, while the control group saw no significant change.

The cost of implementing this tailored IPM was equal to or lower than traditional chemical pest control methods, highlighting its effectiveness and cost-efficiency in urban settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated pest management in an urban community: a successful partnership for prevention. Brenner, BL., Markowitz, S., Rivera, M., et al.[2018]

Recent research highlights that cockroach allergen exposure is significant not only in low-income urban homes but also in suburban areas and schools, indicating a broader public health concern.

Understanding the factors that contribute to or protect against cockroach allergen exposure can help develop targeted interventions to reduce asthma and allergy cases related to these allergens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of environmental cockroach allergen exposure. Chew, GL.[2021]

Cockroach infestations are a significant factor contributing to asthma, with many asthmatic patients showing sensitivity to cockroach allergens.

Effective extermination of cockroaches requires a long-term commitment to a systematic approach, highlighting the need for ongoing efforts in homes, schools, and public buildings to reduce asthma triggers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecology and elimination of cockroaches and allergens in the home. Eggleston, PA., Arruda, LK.[2019]

In a study of 172 households in Recife, Brazil, children exposed to high levels of cockroach infestation (more than 5 dead cockroaches) had a significantly higher prevalence of asthma (31.6%) compared to those not exposed (11.8%), indicating a strong association between cockroach exposure and asthma risk.

The findings suggest that cockroach exposure can be considered a risk factor for asthma in children, with a prevalence ratio of 3.45, highlighting the importance of pest control in reducing asthma incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There are more asthmatics in homes with high cockroach infestation. Sarinho, E., Schor, D., Veloso, MA., et al.[2019]

An educational intervention for caretakers of 150 Hispanic children with asthma led to a 60% reduction in cockroach numbers and a 64% decrease in cockroach allergen levels in bedding after 4 months.

The intervention improved knowledge and behaviors related to cockroach control, demonstrating that a single educational session can effectively reduce allergen exposure in homes with high initial infestations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational intervention to control cockroach allergen exposure in the homes of hispanic children in Los Angeles: results of the La Casa study. McConnell, R., Milam, J., Richardson, J., et al.[2021]

A study involving 49 homes with children allergic to cockroaches showed that professional cleaning combined with insecticide bait traps significantly reduced cockroach counts and allergen levels in homes with high initial infestations.

Intensive cleaning alone also led to significant reductions in cockroach allergen concentrations, particularly in kitchens, highlighting its effectiveness in managing allergen exposure in inner-city homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cockroach counts and house dust allergen concentrations after professional cockroach control and cleaning. McConnell, R., Jones, C., Milam, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Abatement of cockroach allergens (Bla g 1 and Bla g 2) in low-income, urban housing: month 12 continuation results. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of integrated pest management in reducing cockroach allergen concentrations in urban public housing. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A single intervention for cockroach control reduces cockroach exposure and asthma morbidity in children. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Abatement of cockroach allergen (Bla g 1) in low-income, urban housing: A randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Integrated pest management in an urban community: a successful partnership for prevention. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of environmental cockroach allergen exposure. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ecology and elimination of cockroaches and allergens in the home. [2019]

8. Brazil pubmed.ncbi.nlm.nih.gov

There are more asthmatics in homes with high cockroach infestation. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Educational intervention to control cockroach allergen exposure in the homes of hispanic children in Los Angeles: results of the La Casa study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cockroach counts and house dust allergen concentrations after professional cockroach control and cleaning. [2021]