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

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Sponsor:

Information provided by (Responsible Party):

Johns Hopkins University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Asthma
Interventions	Drug: Flovent Diskus Other: Home Environmental Intervention Drug: Advair Diskus
Enrollment	155

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	ECS + Medication Group	Medication Group Alone
Arm/Group Description	The Environmental Control Strategy ...	inhaled corticosteroids or inhaled ...
Arm/Group Description	The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding Advair Diskus: inhaled corticosteroids + long-acting beta agonist	inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist
Period Title: Overall Study
Started	77	78
Completed	57	58
Not Completed	20	20

Baseline Characteristics

Arm/Group Title		ECS + Medication Group	Medication Group Alone	Total
Arm/Group Description		The Environmental Control Strategy ...	inhaled corticosteroids or inhaled ...	Total of all reporting groups
Arm/Group Description		The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding Advair Diskus: inhaled corticosteroids + long-acting beta agonist	inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist	Total of all reporting groups
Overall Number of Baseline Participants		77	78	155
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	77 participants	78 participants	155 participants
		10.1 (3.3)	10.1 (3.3)	10.1 (3.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Female	31 40.3%	30 38.5%	61 39.4%
	Male	46 59.7%	48 61.5%	94 60.6%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	Hispanic or Latino	2 2.6%	2 2.6%	4 2.6%
	Not Hispanic or Latino	75 97.4%	76 97.4%	151 97.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	77 participants	78 participants	155 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	72 93.5%	67 85.9%	139 89.7%
	White	1 1.3%	3 3.8%	4 2.6%
	More than one race	4 5.2%	8 10.3%	12 7.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	77 participants	78 participants	155 participants
United States		77 100.0%	78 100.0%	155 100.0%
The treatment step assigned ^[1] Mean (Standard Deviation) Unit of measure: Score on a scale
	Number Analyzed	77 participants	78 participants	155 participants
		4.34 (1.56)	4.56 (1.57)	4.45 (1.56)
		[1] Measure Description: 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.

Outcome Measures

1.Primary Outcome


Title	The Medication Treatment Step Assigned
Description	The controller medication treatment step that was assigned at the visi...
Description	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.
Time Frame	6 month clinic visit

Outcome Measure Data