The Allergen Reduction and Child Health Study (ARCHS)

NCT04331353 | Recruiting

• 2 other identifiers: 2019-2199AD-2018C3-14869
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma in Children

Keywords

asthma; cockroach allergen; indoor allergens; pulmonary function; childhood asthma; environmental intervention

Outcome Measures

Primary Outcomes (3)

• Maximum number of symptom days in the previous two weeks

  The number of days with asthma symptoms (chest tightness, cough, wheeze, disrupted sleep, limitations on physical activities) in the previous two weeks.

  12 Months

• Number of participants with an asthma related hospitalization, unscheduled clinic or emergency room visit for asthma in the previous month

  Hospitalization or emergency room visit for asthma or unscheduled doctor visit for asthma in the previous month.

  12 Months

• Level of Asthma control

  The level of asthma control assessed using the Asthma Control Test. The scores range from 5 to 25 with higher scores reflecting greater asthma control.

  12 Months

Secondary Outcomes (2)

• Asthma quality of life

  12 Months

• Cockroach exposure

  Baseline, 3, 6, 9, 12 months

Study Arms (2)

Comparator 1 (tailored approach)

ACTIVE COMPARATOR

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

Behavioral: Comparator 1 (tailored approach)

Comparator 2 (insecticidal bait)

ACTIVE COMPARATOR

Insecticidal bait for cockroach reduction.

Behavioral: Comparator 2 (insecticidal bait)

Interventions

Comparator 1 (tailored approach) BEHAVIORAL

Tailored to a child's sensitization status. Components include, education, cockroach baiting, mattress and bed covers, high efficiency particulate air (HEPA) vacuum cleaner, air purifier.

Comparator 1 (tailored approach)

Comparator 2 (insecticidal bait) BEHAVIORAL

Cockroach bait

Comparator 2 (insecticidal bait)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 5 - 17 years; with uncontrolled persistent asthma defined as the child experiencing at least one of the following: one overnight hospitalization for asthma within the past six months OR two unscheduled clinic or emergency department visits for asthma within the last 12 months; and either on a long term controller medication for asthma, or have asthma symptoms 3 or more days per week over the past 2 weeks or nighttime asthma symptoms at least 3 times in the past month exposure to cockroach - defined as trapping at least one cockroach in a 3 day period OR visual evidence of cockroaches by field staff; and the child must sleep in the target home at least 4 nights per week on average. Caregiver ability to speak English or Spanish.

You may not qualify if:

• Other serious medical or chronic illnesses including chronic respiratory infections that require daily medication, cardiovascular disease that requires daily medication, excluding hypertension, taking a beta-blocker, a current active smoker, currently receiving immunotherapy or plans to move within the 12 month follow-up.

Sponsors & Collaborators

• Tulane University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Felicia Rabito, PhD

  Tulane University School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Werthmann, PhD

CONTACT

5049882386; dwrthma@tulane.edu

Joanna Baisier

CONTACT

5049883430; jbaisier@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: November 15, 2020
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)