Environmental Control as Add-on Therapy in Childhood Asthma

Asthma Clinical Trial

— ECATCh  

Official title:

Environmental Control as Add-on Therapy in Childhood Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251379
• Other study ID #: NA_00093323
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2014
• Est. completion date: November 2018

Study information

• Verified date: November 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Flovent Diskus
Inhaled corticosteroids

Other:
• Home Environmental Intervention
Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Drug:
• Advair Diskus
inhaled corticosteroids + long-acting beta agonist

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily Inhaled Corticosteroid Dose	micrograms of inhaled corticosteroids (daily)	6 months
Secondary	Exhaled Nitric Oxide	Exhaled nitric oxide in parts per billion.	6 months
Secondary	Number of Asthma Symptom Days	Number of asthma symptom days in the past two weeks will be a measure of asthma control.	6 months
Secondary	Number of Asthma Exacerbations	Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.	6 months
Secondary	FEV1/FVC	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