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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children with asthma by reducing cockroach exposure in their homes. Researchers will test two methods: a personalized approach based on each child's allergies (Comparator 1, tailored approach) and a simple, low-toxicity insecticidal bait (Comparator 2). The goal is to determine if these methods improve asthma symptoms, reduce doctor visits, and enhance quality of life. Children who frequently experience asthma symptoms or hospital visits, live in homes with cockroaches, and reside in the Greater New Orleans area might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve asthma management for children.

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 prior data suggests that this intervention is safe for children with asthma?

Research has shown that integrated pest management, which includes education, insecticide bait, and professional cleaning, effectively reduces cockroach numbers and allergens in homes. This method has improved health for children with asthma. Studies indicate it significantly lowers cockroach exposure and asthma symptoms over time.

Specifically, studies suggest that insecticide baits are generally safer for children than sprays or bombs. Baits are less likely to worsen asthma symptoms, which is crucial for children with asthma. However, limiting children's exposure to any pesticide is important to ensure their safety.

While this tailored approach and the use of insecticide bait have shown positive results, it is essential to follow safety guidelines to minimize any potential risks to children's health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood asthma because they focus on reducing cockroach allergens, which are a common trigger for asthma attacks. Unlike traditional asthma treatments that primarily focus on managing symptoms with inhalers or medication, these interventions aim to tackle the problem at its source. The tailored approach is unique because it uses a multi-component strategy customized to each child's allergic profile, potentially offering a more personalized and effective solution. Meanwhile, the use of insecticidal bait directly targets and reduces the cockroach population, which could significantly decrease allergen levels in the home environment. By addressing the root cause of asthma triggers, these treatments have the potential to improve long-term asthma management and quality of life for children.

What evidence suggests that this trial's treatments could be effective for childhood asthma?

This trial will compare two methods for reducing cockroach exposure to improve asthma symptoms in children. One group of participants will receive a tailored approach addressing a child's specific allergies, which studies have shown helps reduce asthma symptoms by lowering allergen levels in the home. Another group will use insecticidal bait, which research indicates effectively reduces the number of cockroaches in homes, leading to better asthma outcomes. Both methods aim to create a healthier living space for children with asthma by focusing on reducing key allergens like cockroach exposure. ^{6 7 8 9 10}

Who Is on the Research Team?

Felicia Rabito, PhD

Principal Investigator

Tulane University School of Public Health and Tropical Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28108117/

A single intervention for cockroach control reduces ... We sought to test the use of a single intervention, insecticidal bait, to reduce cockroach exposure in the home of children with asthma in New Orleans.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165269/

Environmental Exposures Impact Pediatric Asthma Within ... Alternatively, Rabito and colleagues performed a single intervention against cockroach using insecticidal bait which was successful in reducing cockroach number ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04331353

The Allergen Reduction and Child Health Study (ARCHS) Specific Aim 3 examines whether the effect of insecticidal control on asthma outcomes differs by the allergen profile of the child. The investigators ...

4. sph.unc.edu sph.unc.edu/wp-content/uploads/sites/112/2018/06/A-Single-Intervention-for-Cockroach-Control-Reduces-Cockroach-exposure-and-Asthma-Morbidity-in-Children.pdf

A-Single-Intervention-for-Cockroach-Control-Reduces- ... To address this data gap, we conducted a single-intervention trial of insecticidal baits in the homes of children with asthma. The goals of the ...

5. journalistsresource.org journalistsresource.org/economics/asthma-prevention-research-solutions/

Interventions to prevent childhood asthma attacks This study tests the effects of insecticidal bait on cockroach exposure and asthma outcomes among 102 children enrolled in a year-long ...

6. beyondpesticides.org beyondpesticides.org/assets/media/documents/children/asthma/AsthmaBrochureCited.pdf

Asthma, Children and Pesticides Our data suggest that pesticide exposure during early childhood increases asthma risk by age 5, ... Material Safety Data Sheet for TEMPO SC Ultra Insecticide. 55 ...

7. epa.gov epa.gov/sites/default/files/2015-12/documents/pest-impact-hsstaff.pdf

Pesticides and Their Impact on Children Pesticide poisoning is especially harmful to children since their brain and nervous systems are at early critical stages of development.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5813803/

Pesticide Exposure in Children - PMC - PubMed Central Exposures to pesticides may be overt or subacute, and effects range from acute to chronic toxicity. In 2008, pesticides were the ninth most common substance ...

9. elevatenp.org elevatenp.org/publications/asthma-pests-and-pesticides/

Asthma, Pests, and Pesticides - Elevate Energy Bait pesticide products for cockroaches, mice, and rats are less likely to trigger asthma than sprays or bombs. Check your local hardware store ...

10. extension.psu.edu extension.psu.edu/asthma-pests-and-pesticides/

Asthma, Pests, and Pesticides To be safe, it is important to limit children's exposures to toxins of all kinds, including pesticides. What Can You Do to Safely Control Pests?