Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT04331353

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Comparator 1 (tailored approach)

Comparator 2 (insecticidal bait)

Study Details

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

Study ID

NCT04331353

Start date

Nov 15, 2020

Status verified date

Sep, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Comparator 1 (tailored approach)

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

active comparator: Comparator 2 (insecticidal bait)

Insecticidal bait for cockroach reduction.

Interventions

Comparator 1 (tailored approach)

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 2 (insecticidal bait)

Cockroach bait

Primary outcome measure

  • Maximum number of symptom days in the previous two weeks [ Time Frame: 12 Months ]
  • Number of participants with an asthma related hospitalization, unscheduled clinic or emergency room visit for asthma in the previous month [ Time Frame: 12 Months ]
  • Level of Asthma control [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Derek Werthmann, PhD

5049882386dwrthma@tulane.edu

Joanna Baisier

5049883430jbaisier@tulane.edu

Locations

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Derek W Werthmann, MPH

5049882386dwerthma@tulane.edu

Principal Investigator:

Felicia A Rabito, PhD

More Information

Sponsor

Tulane University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2025-09-09.