Trial Outcomes & Findings for A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma. (NCT NCT00419952)
NCT ID: NCT00419952
Last Updated: 2012-10-30
Results Overview
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
COMPLETED
PHASE3
742 participants
52 Weeks
2012-10-30
Participant Flow
First patient enrolled on 8 February 2007, the last patient completed the study on 30 November 2009. The study randomized participants only in the United States.
The study included a run-in period of 2 weeks when all patients were prescribed budesonide HFA pMDI 160 μg times 2 actuations BID at individual daily doses and rescue medication, as needed. To be randomized to treatment the patients needed to show pre-dose FEV1 of ≥50%. One patient in the budesonide group did not receive any dose.
Participant milestones
| Measure |
Symbicort
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Overall Study
STARTED
|
377
|
365
|
|
Overall Study
COMPLETED
|
228
|
240
|
|
Overall Study
NOT COMPLETED
|
149
|
125
|
Reasons for withdrawal
| Measure |
Symbicort
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
44
|
43
|
|
Overall Study
Lost to Follow-up
|
43
|
34
|
|
Overall Study
Protocol Violation
|
32
|
24
|
|
Overall Study
Pregnancy
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Incorrectly enrolled
|
10
|
3
|
|
Overall Study
Intake of prohibited medication
|
2
|
2
|
|
Overall Study
Occurence of 2 or more exacerbations
|
2
|
0
|
|
Overall Study
Diary or medication non-compliance
|
2
|
4
|
|
Overall Study
Abnormal ECG
|
1
|
0
|
Baseline Characteristics
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Baseline characteristics by cohort
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=365 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
Total
n=742 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
36.19 Years
STANDARD_DEVIATION 15.67 • n=5 Participants
|
38.35 Years
STANDARD_DEVIATION 15.22 • n=7 Participants
|
37.27 Years
STANDARD_DEVIATION 15.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 WeeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Outcome measures
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=364 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Total Number of Asthma Exacerbations
|
36 Exacerbations
NA
|
61 Exacerbations
NA
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Number of participants with at least 1 exacerbation
Outcome measures
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=364 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Asthma Exacerbations
|
29 Participants
Interval -1.01 to 0.79
|
51 Participants
Interval -1.23 to 0.61
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
QT interval corrected using the Fridericia formula \[QTc (Frid)\] - Change from baseline to end of treatment
Outcome measures
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=364 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
|
-0.11 msec
Interval -1.01 to 0.79
|
-0.31 msec
Interval -1.23 to 0.61
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks (visit 4)Population: Data were available for a subset of patients.
Total ectopic ventricular (VE) beats - number of participants with shift from normal (\<50) to high (≥50) from baseline to visit 4.
Outcome measures
| Measure |
Symbicort
n=59 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=63 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks (visit 4)Population: Data were available for a subset of patients
Total ectopic supraventricular (VE) beats - number of participants with shift normal (\<50) to high (≥50) from baseline to visit 4.
Outcome measures
| Measure |
Symbicort
n=60 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=67 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks (visit 4)Population: Data were available for a subset of patients.
Total ventricular runs - number of participants with shift normal (\<1) to high (≥1) from baseline to week 2.
Outcome measures
| Measure |
Symbicort
n=63 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=74 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
|
2 Participants
Interval 13.43 to 18.34
|
1 Participants
Interval 8.11 to 13.13
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day
Outcome measures
| Measure |
Symbicort
n=369 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=353 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Diary Assessments - Rescue-free Day
|
15.88 Percentage of Rescue Free Day
Interval 13.43 to 18.34
|
10.62 Percentage of Rescue Free Day
Interval 8.11 to 13.13
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day
Outcome measures
| Measure |
Symbicort
n=369 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=353 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Diary Assessments - Symptom-free Day
|
9.46 percentage of Symptom-free day
Interval 7.55 to 11.37
|
7.58 percentage of Symptom-free day
Interval 5.62 to 9.53
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day
Outcome measures
| Measure |
Symbicort
n=369 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=353 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Diary Assessments - Asthma-control Day
|
16.68 percentage of Asthma-control day
Interval 14.16 to 19.21
|
11.62 percentage of Asthma-control day
Interval 9.04 to 14.2
|
SECONDARY outcome
Timeframe: 1 weekPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Outcome measures
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=364 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Onset of Effect Questionnaire (OEQ)
|
172 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Outcome measures
| Measure |
Symbicort
n=377 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=364 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Onset of Effect Questionnaire (OEQ)
|
165 Participants
Interval 46.19 to 49.8
|
157 Participants
Interval 43.95 to 47.33
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
Outcome measures
| Measure |
Symbicort
n=364 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=349 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Peak Expiratory Flow (PEF) in Morning
|
30.13 Liters/minute
Interval 24.38 to 35.87
|
19.73 Liters/minute
Interval 13.86 to 25.59
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
Outcome measures
| Measure |
Symbicort
n=359 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=354 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
|
0.08 Litres
Interval 0.05 to 0.11
|
-0.01 Litres
Interval -0.04 to 0.01
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.
Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.
Outcome measures
| Measure |
Symbicort
n=203 Participants
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=232 Participants
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Asthma Treatment Satisfaction Measure (ATSM)
|
47.99 units on a scale
Interval 46.19 to 49.8
|
45.64 units on a scale
Interval 43.95 to 47.33
|
Adverse Events
Symbicort
Budesonide
Serious adverse events
| Measure |
Symbicort
n=377 participants at risk
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=365 participants at risk
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Gastrointestinal disorders
Oesophageal Fistula
|
0.00%
0/377
|
0.27%
1/365
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.27%
1/377
|
0.00%
0/365
|
|
Infections and infestations
Cellulitis
|
0.27%
1/377
|
0.00%
0/365
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/377
|
0.00%
0/365
|
|
Infections and infestations
Pneumonia
|
0.00%
0/377
|
0.27%
1/365
|
|
Infections and infestations
Pneumonia Bacterial
|
0.27%
1/377
|
0.27%
1/365
|
|
Infections and infestations
Subcutaneous Abscess
|
0.27%
1/377
|
0.00%
0/365
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/377
|
0.27%
1/365
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.00%
0/377
|
0.27%
1/365
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/377
|
0.27%
1/365
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.27%
1/377
|
0.00%
0/365
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.53%
2/377
|
0.00%
0/365
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.53%
2/377
|
0.00%
0/365
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.27%
1/377
|
0.00%
0/365
|
|
Nervous system disorders
Headache
|
0.00%
0/377
|
0.27%
1/365
|
|
Nervous system disorders
Migraine
|
0.00%
0/377
|
0.27%
1/365
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/377
|
0.27%
1/365
|
|
Psychiatric disorders
Depression
|
0.00%
0/377
|
0.27%
1/365
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/377
|
0.27%
1/365
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/377
|
0.27%
1/365
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.27%
1/377
|
0.00%
0/365
|
|
Reproductive system and breast disorders
Ovarian Mass
|
0.27%
1/377
|
0.00%
0/365
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/377
|
1.1%
4/365
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.27%
1/377
|
0.00%
0/365
|
Other adverse events
| Measure |
Symbicort
n=377 participants at risk
Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
|
Budesonide
n=365 participants at risk
Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.9%
26/377
|
7.9%
29/365
|
|
Infections and infestations
Sinusitis
|
4.0%
15/377
|
6.3%
23/365
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.8%
22/377
|
4.4%
16/365
|
|
Nervous system disorders
Headache
|
9.5%
36/377
|
7.4%
27/365
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.0%
19/377
|
2.5%
9/365
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may use the Multi-Center Study Results and the Site Data for the limited purpose of his or her own research and academic analysis until the earlier of the publication of the first Multi-Center Study at all participating sites
- Publication restrictions are in place
Restriction type: OTHER