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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 dose

Allergic 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

Page last updated: August 23, 2015

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