Clinical trial NCT02251379: Environmental Control as Add-on Therapy in Childhood Asthma
Official title: Environmental Control as Add-on Therapy in Childhood Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 155
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 the 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 the children 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, dust mites, 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 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 National Asthma Education and Prevention Program (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 immunoglobulin E (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

Primary outcomes:
measure: The Medication Treatment Step Assigned
timeFrame: 6 month clinic visit
Secondary outcomes:
measure: Daily Inhaled Corticosteroid Dose
timeFrame: 6 months
measure: Exhaled Nitric Oxide
timeFrame: 6 months
measure: Number of Asthma Symptom Days
timeFrame: 6 months
measure: Number of Asthma Exacerbations
timeFrame: 6 months
measure: FEV1/FVC
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elizabeth C Matsui, MD MHS
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Meredith McCormack, MD MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Corinne Keet, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: