Health TrialsbyHealthPanel

The Allergen Reduction and Child Health Study (ARCHS)

ConditionAsthma in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorTulane University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 2 (insecticidal bait)

    Behavioral

    Cockroach bait

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Comparator 1 (tailored approach)Active comparator 1 intervention
Group B: Comparator 2 (insecticidal bait)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 Months
2

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.

Time frame
12 Months
3

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.

Time frame
12 Months

Secondary outcomes

1

Asthma quality of life

Quality of life measured using the Pediatric Asthma Quality of Life Questionnaire. 7 point Likert scale (Minimum:1 Maximum:7) all items are weighted equally. Higher scores indicate higher quality of life.

Time frame
12 Months
2

Cockroach exposure

The number of cockroaches in the home and the level of cockroach antigen in the dust

Time frame
Baseline, 3, 6, 9, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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