- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251379
Environmental Control as Add-on Therapy in Childhood Asthma (ECATCh)
November 8, 2019 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
155
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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)
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
Inhaled corticosteroids
Other Names:
Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding
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)
|
Inhaled corticosteroids
Other Names:
inhaled corticosteroids + long-acting beta agonist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 month clinic visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Inhaled Corticosteroid Dose
Time Frame: 6 months
|
micrograms of inhaled corticosteroids (daily)
|
6 months
|
Exhaled Nitric Oxide
Time Frame: 6 months
|
Exhaled nitric oxide in parts per billion.
|
6 months
|
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.
|
6 months
|
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.
|
6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
September 22, 2014
First Submitted That Met QC Criteria
September 25, 2014
First Posted (Estimate)
September 29, 2014
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 8, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Sympathomimetics
- Fluticasone
- Xhance
- Fluticasone-Salmeterol Drug Combination
Other Study ID Numbers
- NA_00093323
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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