Environmental Control as Add-on Therapy in Childhood Asthma

NCT ID: NCT02251379

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2018-11-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECS + Medication Group

The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Group Type: EXPERIMENTAL

Flovent Diskus

Intervention Type: DRUG

Inhaled corticosteroids

Home Environmental Intervention

Intervention Type: OTHER

Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus

Intervention Type: DRUG

inhaled corticosteroids + long-acting beta agonist

Medication Group Alone

inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Group Type: ACTIVE_COMPARATOR

Flovent Diskus

Intervention Type: DRUG

Inhaled corticosteroids

Advair Diskus

Intervention Type: DRUG

inhaled corticosteroids + long-acting beta agonist

Interventions

Flovent Diskus

Inhaled corticosteroids

Intervention Type: DRUG

Home Environmental Intervention

Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Intervention Type: OTHER

Advair Diskus

inhaled corticosteroids + long-acting beta agonist

Intervention Type: DRUG

Other Intervention Names

Flovent Diskus, 50 mcg, 100mcg, 250 mcg

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth C Matsui, MD MHS

Role: STUDY_CHAIR

Johns Hopkins University

Meredith McCormack, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Corinne Keet, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00093323

Identifier Type: -

Identifier Source: org_study_id