Environmental Control as Add-on Therapy in Childhood Asthma (ECATCh)
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| ClinicalTrials.gov Identifier: NCT02251379 |
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Recruitment Status :
Completed
First Posted : September 29, 2014
Results First Posted : November 4, 2019
Last Update Posted : November 20, 2019
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | September 22, 2014 | |||||||||
| First Posted Date ICMJE | September 29, 2014 | |||||||||
| Results First Submitted Date ICMJE | October 15, 2019 | |||||||||
| Results First Posted Date ICMJE | November 4, 2019 | |||||||||
| Last Update Posted Date | November 20, 2019 | |||||||||
| Actual Study Start Date ICMJE | October 1, 2014 | |||||||||
| Actual Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE |
The treatment step assigned [ Time Frame: 6 month clinic visit ] National Asthma Guidelines treatment step
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Environmental Control as Add-on Therapy in Childhood Asthma | |||||||||
| Official Title ICMJE | Environmental Control as Add-on Therapy in Childhood Asthma | |||||||||
| 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. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
155 | |||||||||
| Original Estimated Enrollment ICMJE |
200 | |||||||||
| Actual Study Completion Date ICMJE | November 2018 | |||||||||
| Actual Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 5 Years to 17 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02251379 | |||||||||
| Other Study ID Numbers ICMJE | NA_00093323 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Johns Hopkins University | |||||||||
| Original Responsible Party | Elizabeth Matsui, Johns Hopkins University, Associate Professor of Pediatrics, Epidemiology, and Environmental Health Sciences | |||||||||
| Current Study Sponsor ICMJE | Johns Hopkins University | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Johns Hopkins University | |||||||||
| Verification Date | November 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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