Environmental Control as Add-on Therapy in Childhood Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 1/10/2019 |
| Start Date: | October 1, 2014 |
| End Date: | November 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-502-3858
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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