- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04331353
The Allergen Reduction and Child Health Study (ARCHS) (ARCHS)
Comparative Effectiveness of Multi Versus Single Intervention Allergen Reduction Strategies on Asthma Morbidity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Significance: Asthma is a serious, complex, and highly prevalent childhood respiratory disorder leading to inflammation and narrowing of the airways. If uncontrolled it negatively impacts long-term lung function. An estimated 6.2 million, 1 in 12, U.S. children have asthma and asthma outcome disparities are pervasive. An important contributor to asthma disparities is greater exposure to asthma triggering allergens. The proposed study addresses an evidence gap related to the most effective way to reduce exposure to asthma triggers in the home.
Study Aims: There are three specific aims. First to compare the effectiveness of a multicomponent intervention to reduce asthma triggers to a single intervention to reduce cockroach exposure in the home testing the hypothesis that among children with asthma exposed to cockroaches, a single intervention targeting cockroach remediation is as effective one with multiple components that targets multiple allergens. Specific Aim 2 compares the effectiveness of the different interventions on the number of cockroaches in the home testing the hypothesis that insecticidal bait is as effective at reducing cockroaches as a multi-component approach. Specific Aim 3 examines whether the effect of insecticidal control on asthma outcomes differs by the allergen profile of the child. The investigators hypothesize that cockroach eradication results in improved outcomes independent of cockroach sensitization status and the number of other allergens to which a child is sensitized. The long term objective is to provide evidence for the NHLBI Expert Panel currently reviewing the Guidelines for the Diagnosis and Management of Asthma (EPR-3) and specifically the effectiveness of indoor allergen reduction strategies on asthma management.
Study Description: A 12-month, two group randomized clinical trial of 290 children ages 5 -17 with doctor diagnosed asthma recruited from clinics in the Greater New Orleans area. Comparator Group 1 targets dust mites, mold, cockroach, animal dander and smoke exposure. Interventions include asthma education, cleaning techniques, impermeable bed covers, HEPA vacuum cleaners, air purification, and insecticidal baiting. Comparator Group 2 targets cockroaches and the intervention is targeted insecticidal baiting.
Primary outcomes include asthma symptom days, asthma-related health care utilization (emergency room visits, hospitalization, unscheduled clinic visits), quality of life, asthma control, medication use, and cockroach burden. Pulmonary function will be measured as a secondary outcome. Asthma outcome data will be collected monthly. Other data will be collected during home visits at baseline, 3, 6, 9 and 12 months.
Each outcome will be modeled separately. Two sets of analyses will be conducted. First, a generalized linear regression model will be employed to model the change score from baseline to 12-months with Comparator group 2 as the predictor and other potential confounders as covariates. In the second approach, intervention effects will be assessed longitudinally by modelling the outcomes at each assessment time (excluding baseline) using models for repeated outcomes such as linear mixed model or generalized estimating equations depending on the distribution of the outcome. Sensitivity analyses will be performed to verify the stability of multiple imputation assumptions using different multiple imputation procedures and consistency of the final results.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Derek Werthmann, PhD
- Phone Number: 5049882386
- Email: dwrthma@tulane.edu
Study Contact Backup
- Name: Joanna Baisier
- Phone Number: 5049883430
- Email: jbaisier@tulane.edu
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University
-
Contact:
- Derek W Werthmann, MPH
- Phone Number: 504-988-2386
- Email: dwerthma@tulane.edu
-
Principal Investigator:
- Felicia A Rabito, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Comparator 1 (tailored approach)
Multi-component intervention tailored to the participant's allergic profile.
|
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.
|
Active Comparator: Comparator 2 (insecticidal bait)
Insecticidal bait for cockroach reduction.
|
Cockroach bait
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum number of symptom days in the previous two weeks
Time Frame: 12 Months
|
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
Time Frame: 12 Months
|
Hospitalization or emergency room visit for asthma or unscheduled doctor visit for asthma in the previous month.
|
12 Months
|
Level of Asthma control
Time Frame: 12 Months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma quality of life
Time Frame: 12 Months
|
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.
|
12 Months
|
Cockroach exposure
Time Frame: Baseline, 3, 6, 9, 12 months
|
The number of cockroaches in the home and the level of cockroach antigen in the dust
|
Baseline, 3, 6, 9, 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Felicia Rabito, PhD, Tulane University School of Public Health and Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-2199
- AD-2018C3-14869 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma in Children
-
Istituto di Farmacologia Traslazionale - sede di...Not yet recruitingAsthma in Children | Children, Only | Serious Game
-
University of FloridaNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingAsthma in ChildrenUnited States
-
ResMedCompletedAsthma in ChildrenUnited States
-
University of WashingtonNational Institute of Environmental Health Sciences (NIEHS); National Institute... and other collaboratorsCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Duke UniversityRecruitingAsthma in ChildrenUnited States
-
Rambam Health Care CampusCompleted
-
Shaoxing Maternity and Child Health Care HospitalRecruiting
-
University of LiverpoolNot yet recruiting
Clinical Trials on Comparator 1 (tailored approach)
-
University of PennsylvaniaRecruiting
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Johns Hopkins University; Ohio State... and other collaboratorsActive, not recruitingHIV Infections | Drug UseVietnam
-
University of ExeterUniversity of Oxford; Ludwig-Maximilians - University of Munich; Universitat... and other collaboratorsActive, not recruitingWellbeing | Mental DisorderBelgium, Germany, Spain, United Kingdom
-
Cairo UniversityMansoura University; Hiroshima UniversityCompletedStroke | Caregiver Burden | Caregiver BurnoutEgypt
-
SVS Institute of Dental SciencesUnknown
-
United States Naval Medical Center, San DiegoTerminatedPTSD - Post Traumatic Stress Disorder
-
Eisai Inc.CompletedHealthy | Drug AbuseCanada
-
Assiut UniversityUnknownPeriampullary Carcinoma ResectableEgypt
-
Beijing Ditan HospitalCompleted