Trial Outcomes & Findings for Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT) (NCT NCT00495157)
NCT ID: NCT00495157
Last Updated: 2013-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
342 participants
Primary outcome timeframe
Measured during the 36-week treatment period
Results posted on
2013-04-11
Participant Flow
Participant milestones
| Measure |
Symptom-based Adjustment
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Biomarker-based Adjustment
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Guideline-based Adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
115
|
114
|
|
Overall Study
COMPLETED
|
97
|
92
|
101
|
|
Overall Study
NOT COMPLETED
|
16
|
23
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Baseline characteristics by cohort
| Measure |
Symptom-based Adjustment
n=113 Participants
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Biomarker-based Adjustment
n=115 Participants
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Guideline-based Adjustment
n=114 Participants
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
337 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Age Continuous
|
36.0 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
34.8 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
34.2 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
35.0 years
STANDARD_DEVIATION 11.8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
237 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=93 Participants
|
115 participants
n=4 Participants
|
114 participants
n=27 Participants
|
342 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured during the 36-week treatment periodPopulation: All participants were followed for time to treatment failure or right censoring (measured in days).
Outcome measures
| Measure |
Symptom-based Adjustment
n=113 Participants
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Biomarker-based Adjustment
n=115 Participants
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Guideline-based Adjustment
n=114 Participants
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
|---|---|---|---|
|
Time to Treatment Failure (Measured in Days)
|
196.9 days
Standard Error 4.0
|
225.2 days
Standard Error 5.6
|
182.3 days
Standard Error 4.7
|
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured during the 36-week treatment periodOutcome measures
Outcome data not reported
Adverse Events
Symptom-based Adjustment
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Biomarker-based Adjustment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Guideline-based Adjustment
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Symptom-based Adjustment
n=113 participants at risk
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Biomarker-based Adjustment
n=115 participants at risk
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Guideline-based Adjustment
n=114 participants at risk
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
|---|---|---|---|
|
General disorders
hospitalizations for unrelated events
|
5.3%
6/113 • Number of events 6
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
Other adverse events
| Measure |
Symptom-based Adjustment
n=113 participants at risk
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Biomarker-based Adjustment
n=115 participants at risk
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
Guideline-based Adjustment
n=114 participants at risk
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
urgent care for asthma
|
1.8%
2/113 • Number of events 2
|
6.1%
7/115 • Number of events 7
|
7.0%
8/114 • Number of events 8
|
Additional Information
Vernon M. Chinchilli, PhD
Penn State Hershey College of Medicine
Phone: 717-531-4262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place