Environmental Control as Add-on Therapy in Childhood Asthma

NCT02251379 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00093323
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The Medication Treatment Step Assigned

  The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.

  6 month clinic visit

Secondary Outcomes (5)

• Daily Inhaled Corticosteroid Dose

  6 months

• Exhaled Nitric Oxide

  6 months

• Number of Asthma Symptom Days

  6 months

• Number of Asthma Exacerbations

  6 months

• FEV1/FVC

  6 months

Study Arms (2)

ECS + Medication Group

EXPERIMENTAL

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

Drug: Flovent Diskus; Other: Home Environmental Intervention; Drug: Advair Diskus

Medication Group Alone

ACTIVE COMPARATOR

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

Drug: Flovent Diskus; Drug: Advair Diskus

Interventions

Flovent Diskus DRUG

Inhaled corticosteroids

Also known as: Flovent Diskus, 50 mcg, 100mcg, 250 mcg

ECS + Medication Group; Medication Group Alone

Home Environmental Intervention OTHER

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

ECS + Medication Group

Advair Diskus DRUG

inhaled corticosteroids + long-acting beta agonist

ECS + Medication Group; Medication Group Alone

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• On a long-term controller medication for asthma, or
• 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:
• One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo
• One asthma-related overnight hospitalization in the previous 12 mo
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Corinne Keet
• Organization: Johns Hopkins University

ckeet1@jhmi.edu

410-955-5883

Study Officials

• Elizabeth C Matsui, MD MHS

  Johns Hopkins University

  STUDY CHAIR

• Meredith McCormack, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Corinne Keet, MD PHD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 29, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Locations

US (1)