Trial Outcomes & Findings for (CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) (NCT NCT00394329)
NCT ID: NCT00394329
Last Updated: 2018-07-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
Measured during the 44-week treatment period
Results posted on
2018-07-02
Participant Flow
Participant milestones
| Measure |
A: Daily ICS + Rescue ICS
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
71
|
74
|
|
Overall Study
COMPLETED
|
63
|
63
|
58
|
50
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
13
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Baseline characteristics by cohort
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
288 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
10.4 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
10.4 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
10.7 years
STANDARD_DEVIATION 3.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
72 participants
n=7 Participants
|
71 participants
n=5 Participants
|
74 participants
n=4 Participants
|
288 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured during the 44-week treatment periodPopulation: All randomized participants were included in the time-to-event analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy
|
22 participants
Interval 15.0 to 31.0
|
20 participants
Interval 13.0 to 29.0
|
25 participants
Interval 17.0 to 33.0
|
36 participants
Interval 27.0 to 45.0
|
SECONDARY outcome
Timeframe: An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Asthma Control Days
|
-0.006 proportion of asthma control days
Standard Error 0.03
|
-0.021 proportion of asthma control days
Standard Error 0.03
|
-0.064 proportion of asthma control days
Standard Error 0.03
|
-0.034 proportion of asthma control days
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day
|
0.26 count of the number of puffs per day
Standard Error 0.11
|
0.24 count of the number of puffs per day
Standard Error 0.08
|
0.26 count of the number of puffs per day
Standard Error 0.09
|
0.18 count of the number of puffs per day
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!)
|
0.104 liters
Standard Error 0.04
|
0.113 liters
Standard Error 0.04
|
0.097 liters
Standard Error 0.05
|
0.063 liters
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR)
|
17.7 liters per minute
Standard Error 4.4
|
16.3 liters per minute
Standard Error 4.8
|
16.5 liters per minute
Standard Error 4.9
|
21.1 liters per minute
Standard Error 5.4
|
SECONDARY outcome
Timeframe: Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR)
|
16.2 liters per minute
Standard Error 4.5
|
14.9 liters per minute
Standard Error 4.4
|
12.9 liters per minute
Standard Error 4.6
|
20.6 liters per minute
Standard Error 5.3
|
SECONDARY outcome
Timeframe: PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5\*(evening PEFR + morning PEFR)}
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability
|
0.836 relative change (AM and PM peak flow)
Standard Error 0.51
|
-0.043 relative change (AM and PM peak flow)
Standard Error 0.56
|
0.098 relative change (AM and PM peak flow)
Standard Error 0.53
|
0.894 relative change (AM and PM peak flow)
Standard Error 0.58
|
SECONDARY outcome
Timeframe: eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion
|
-0.08 parts per billion
Standard Error 0.13
|
0.07 parts per billion
Standard Error 0.11
|
0.58 parts per billion
Standard Error 0.13
|
0.34 parts per billion
Standard Error 0.14
|
SECONDARY outcome
Timeframe: The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best)
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment
|
0.15 units on a scale
Standard Error 0.09
|
0.07 units on a scale
Standard Error 0.11
|
0.05 units on a scale
Standard Error 0.15
|
-0.03 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.Population: All randomized participants were included in the linear mixed-effects model analysis
The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best).
Outcome measures
| Measure |
A: Daily ICS + Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 Participants
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 Participants
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Change Between Week 44 and Week 0 in the Asthma Control Test (ACT)
|
0.17 units on a scale
Standard Error 0.47
|
-0.15 units on a scale
Standard Error 0.46
|
-0.57 units on a scale
Standard Error 0.49
|
-0.76 units on a scale
Standard Error 54
|
Adverse Events
A: Daily ICS + Rescue ICS
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
B: Daily ICS
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
C: Rescue ICS
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
D: Placebo
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Daily ICS + Rescue ICS
n=71 participants at risk
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Daily ICS
n=72 participants at risk
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Rescue ICS
n=71 participants at risk
Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo
n=74 participants at risk
Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Treatment Failure
|
5.6%
4/71 • Number of events 4 • 1 year
does not differ from the clinicaltrials.gov definitions
|
2.8%
2/72 • Number of events 2 • 1 year
does not differ from the clinicaltrials.gov definitions
|
8.5%
6/71 • Number of events 6 • 1 year
does not differ from the clinicaltrials.gov definitions
|
23.0%
17/74 • Number of events 17 • 1 year
does not differ from the clinicaltrials.gov definitions
|
Other adverse events
Adverse event data not reported
Additional Information
Vernon M. Chinchilli, PhD
Penn State College of Medicine
Phone: 717-531-4262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place