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

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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:
Information provided by (Responsible Party):
Johns Hopkins University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251379


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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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:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02251379    
Other Study ID Numbers: NA_00093323
First Posted: September 29, 2014    Key Record Dates
Results First Posted: November 4, 2019
Last Update Posted: November 20, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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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