Trial Outcomes & Findings for Environmental Control as Add-on Therapy in Childhood Asthma (NCT NCT02251379)
NCT ID: NCT02251379
Last Updated: 2019-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
6 month clinic visit
Results posted on
2019-11-20
Participant Flow
Participant milestones
| Measure |
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)
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
|
Medication Group Alone
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
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
|
Overall Study
COMPLETED
|
57
|
58
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Environmental Control as Add-on Therapy in Childhood Asthma
Baseline characteristics by cohort
| Measure |
ECS + Medication Group
n=77 Participants
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
|
Medication Group Alone
n=78 Participants
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
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 3.3 • n=93 Participants
|
10.1 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
10.1 years
STANDARD_DEVIATION 3.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
72 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
77 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
The treatment step assigned
|
4.34 score on a scale
STANDARD_DEVIATION 1.56 • n=93 Participants
|
4.56 score on a scale
STANDARD_DEVIATION 1.57 • n=4 Participants
|
4.45 score on a scale
STANDARD_DEVIATION 1.56 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6 month clinic visitPopulation: participants completing the final 6 month follow-up 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.
Outcome measures
| Measure |
ECS + Medication Group
n=63 Participants
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
|
Medication Group Alone
n=62 Participants
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
|
|---|---|---|
|
The Medication Treatment Step Assigned
|
4.03 score on a scale
Standard Deviation 1.91
|
4.05 score on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants who completed the final follow-up visit at 6 months
micrograms of inhaled corticosteroids (daily)
Outcome measures
| Measure |
ECS + Medication Group
n=63 Participants
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
|
Medication Group Alone
n=62 Participants
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
|
|---|---|---|
|
Daily Inhaled Corticosteroid Dose
|
557.5 micrograms/day
Standard Deviation 347.8
|
527.7 micrograms/day
Standard Deviation 401.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.
Exhaled nitric oxide in parts per billion.
Outcome measures
| Measure |
ECS + Medication Group
n=58 Participants
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
|
Medication Group Alone
n=61 Participants
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
|
|---|---|---|
|
Exhaled Nitric Oxide
|
20 parts per billion
Interval 10.0 to 38.0
|
20 parts per billion
Interval 8.0 to 52.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants who completed the final follow-up visit at 6 months.
Number of asthma symptom days in the past two weeks will be a measure of asthma control.
Outcome measures
| Measure |
ECS + Medication Group
n=62 Participants
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
|
Medication Group Alone
n=63 Participants
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
|
|---|---|---|
|
Number of Asthma Symptom Days
|
2.5 days
Standard Deviation 3.2
|
2.7 days
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants completing the 6 month follow-up visit
Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
Outcome measures
| Measure |
ECS + Medication Group
n=63 Participants
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
|
Medication Group Alone
n=62 Participants
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
|
|---|---|---|
|
Number of Asthma Exacerbations
|
35 acute visits
|
53 acute visits
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants completing the 6 month follow-up visit
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.
Outcome measures
| Measure |
ECS + Medication Group
n=63 Participants
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
|
Medication Group Alone
n=62 Participants
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
|
|---|---|---|
|
FEV1/FVC
|
79.3 ratio
Standard Deviation 8.1
|
80.8 ratio
Standard Deviation 8.8
|
Adverse Events
ECS + Medication Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Medication Group Alone
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ECS + Medication Group
n=77 participants at risk
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
|
Medication Group Alone
n=78 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma hospitalization
|
2.6%
2/77 • Number of events 2 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
10.3%
8/78 • Number of events 11 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
|
Psychiatric disorders
hospitalization
|
0.00%
0/77 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
1.3%
1/78 • Number of events 1 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
|
Gastrointestinal disorders
hospitalization
|
0.00%
0/77 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
1.3%
1/78 • Number of events 1 • During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place