Environmental Control as Add-on Therapy in Childhood Asthma
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Flovent Diskus (Drug); Home Environmental Intervention (Other); Advair Diskus (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Elizabeth C Matsui, MD MHS, Principal Investigator, Affiliation: Johns Hopkins University Meredith McCormack, MD MHS, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Susan Balcer Whaley, MPH, Phone: 410-502-9264, Email: swhaley1@jhmi.edu
Summary
This study evaluates the effects of adding on an environmental home intervention to standard
asthma medication management on controller medication requirements among children and
adolescents with asthma. The investigators hypothesize that the addition of an
individually-tailored, multi-faceted Environmental Control Strategy (ECS) to
guidelines-based controller medication will result in less controller medication requirement
and allergic inflammation than controller medication alone among urban asthmatic children.
Clinical Details
Official title: Environmental Control as Add-on Therapy in Childhood Asthma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The treatment step assigned
Secondary outcome: Daily inhaled corticosteroid doseAllergic inflammation markers Measures of asthma control Measures of exacerbations FEV1/FVC Change in FEV1 after albuterol use Asthma severity as measured by CASI
Detailed description:
The study is a parallel arm study of an individually tailored, multi-faceted ECS plus
controller medication titration versus controller medication titration alone. After a
4-week run-in period to stabilize their asthma, the investigators will randomize 200
Baltimore children with persistent asthma and a recent exacerbation in a 1: 1 ratio to the
two arms and follow them for six months. There will be five clinic visits and three home
visits over this time period for clinical and home assessments, respectively. There will be
up to four environmental intervention visits for participants randomized to the
environmental control plus controller medication group. The environmental modules include
mouse, cockroach, furry pets, dustmites, and smoking. Air purifiers and laundered bedding
are also included in this arm. Participants randomized to the controller medication group
have the option of having one home visit after completing the study at which the
participants will receive home intervention services that the environmental control plus
controller medication group received. Participants will have repeated assessment of:
controller medication requirements; secondary clinical, physiologic, and inflammatory
outcomes; and particulate matter (PM), air nicotine, and allergen levels.
Eligibility
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or
asthma symptoms for at least 1 year
- Meet criteria for current persistent asthma defined as either:
1. On a long-term controller medication for asthma, or
2. Meet NAEPP guideline requirements for persistent disease:(46)
- Asthma symptoms 3 or more days per week over the past 2 weeks OR
- Nocturnal asthma symptoms at least 3 times in the past month
- Have evidence of uncontrolled disease as defined by at least one of the following:
1. One asthma-related unscheduled visit to an emergency department (ED), clinic or
urgent care facility in the previous 12 mo
2. One asthma-related overnight hospitalization in the previous 12 mo
3. One or more bursts of oral corticosteroids in the previous 12 mo
- Reside within a geographic area of the study site so that home visits are feasible.
- Have no plans to move within the upcoming 6 months
- Have insurance to cover prescription medications.
- Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust
mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific
IgE test, as quantified using the ImmunoCAP system (≥0. 35 kU/L)
Exclusion Criteria:
- Lung disease, other than asthma, that requires daily medication
- Cardiovascular disease that requires daily medication, excluding hypertension
- Taking a beta-blocker
- Allergy to dairy
- On Xolair < 5 months
- On immunotherapy and has not reached maintenance dose
- Sleeping in another home 4 or more nights/week
- Active smoker defined as a positive urine screen for high levels of urine cotinine
- Unable to access areas of home necessary to conduct extermination
Locations and Contacts
Susan Balcer Whaley, MPH, Phone: 410-502-9264, Email: swhaley1@jhmi.edu Additional Information
Starting date: October 2014
Last updated: September 25, 2014
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