Environmental Control as Add-on Therapy in Childhood Asthma (ECATCh)

• ClinicalTrials.gov Identifier: NCT02251379
• Recruitment Status: Completed
• First Posted: September 29, 2014
• Results First Posted: November 4, 2019
• Last Update Posted: November 20, 2019
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Flovent Diskus; Other: Home Environmental Intervention; Drug: Advair Diskus	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 155 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Environmental Control as Add-on Therapy in Childhood Asthma
• Actual Study Start Date: October 1, 2014
• Actual Primary Completion Date: November 2018
• Actual Study Completion Date: November 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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)	Drug: Flovent Diskus; Inhaled corticosteroids; Other Name: Flovent Diskus, 50 mcg, 100mcg, 250 mcg; Other: Home Environmental Intervention; Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding; Drug: Advair Diskus; inhaled corticosteroids + long-acting beta agonist
Active Comparator: Medication Group Alone; inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)	Drug: Flovent Diskus; Inhaled corticosteroids; Other Name: Flovent Diskus, 50 mcg, 100mcg, 250 mcg; Drug: Advair Diskus; inhaled corticosteroids + long-acting beta agonist

Outcome Measures

Primary Outcome Measures :

1. The Medication Treatment Step Assigned [ Time Frame: 6 month clinic visit ]
   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.

Secondary Outcome Measures :

1. Daily Inhaled Corticosteroid Dose [ Time Frame: 6 months ]
   micrograms of inhaled corticosteroids (daily)
2. Exhaled Nitric Oxide [ Time Frame: 6 months ]
   Exhaled nitric oxide in parts per billion.
3. Number of Asthma Symptom Days [ Time Frame: 6 months ]
   Number of asthma symptom days in the past two weeks will be a measure of asthma control.
4. Number of Asthma Exacerbations [ Time Frame: 6 months ]
   Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
5. FEV1/FVC [ Time Frame: 6 months ]
   Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Study Chair: Elizabeth C Matsui, MD MHS; Johns Hopkins University
• Principal Investigator: Meredith McCormack, MD MHS; Johns Hopkins University
• Principal Investigator: Corinne Keet, MD PHD; Johns Hopkins University

  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] October 3, 2016

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02251379
• Other Study ID Numbers: NA_00093323
• First Posted: September 29, 2014
• Results First Posted: November 4, 2019
• Last Update Posted: November 20, 2019
• Last Verified: November 2019

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sympathomimetics; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents