Trial Outcomes & Findings for Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults (NCT NCT00385593)
NCT ID: NCT00385593
Last Updated: 2010-12-16
Results Overview
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
654 participants
Primary outcome timeframe
Baseline up to 6 months
Results posted on
2010-12-16
Participant Flow
654
Participant milestones
| Measure |
SMART
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Overall Study
STARTED
|
328
|
326
|
|
Overall Study
COMPLETED
|
270
|
289
|
|
Overall Study
NOT COMPLETED
|
58
|
37
|
Reasons for withdrawal
| Measure |
SMART
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
17
|
7
|
|
Overall Study
Lost to Follow-up
|
12
|
8
|
|
Overall Study
Protocol Violation
|
7
|
4
|
|
Overall Study
Several reasons
|
17
|
15
|
|
Overall Study
Incorrect inclusion
|
2
|
0
|
|
Overall Study
Incorrect randomization
|
0
|
1
|
Baseline Characteristics
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Baseline characteristics by cohort
| Measure |
SMART
n=328 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=326 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.7 Years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
44.0 Years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 monthsSevere asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
Outcome measures
| Measure |
SMART
n=328 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=326 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation
|
174.39 Days
Standard Deviation 1.76
|
178.97 Days
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsSevere asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Outcome measures
| Measure |
SMART
n=328 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=326 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Total Number of Severe Exacerbations
|
24 Exacerbations
|
34 Exacerbations
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsMean use of as needed medication during the treatment period
Outcome measures
| Measure |
SMART
n=308 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=320 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Mean Use of as Needed Medication
|
1.03 Inhalations
Full Range 0 • Interval 0.0 to 6.0
|
1.02 Inhalations
Full Range 0 • Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsMean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Outcome measures
| Measure |
SMART
n=328 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=326 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Use of Inhaled Steroids
|
799 micrograms
Full Range 250 • Interval 250.0 to 2000.0
|
1184 micrograms
Full Range 200 • Interval 200.0 to 4000.0
|
SECONDARY outcome
Timeframe: Daily 14 days prior to each of visit 2-4The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Outcome measures
| Measure |
SMART
n=301 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=306 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Change in the Asthma Control Questionnaire(ACQ) Score
|
0.99 Scores on a scale
Full Range 0.0 • Interval 0.0 to 4.0
|
1.08 Scores on a scale
Full Range 0.0 • Interval 0.0 to 3.4
|
SECONDARY outcome
Timeframe: 6 months (end of the study)Peak expiratory flow (PEF)
Outcome measures
| Measure |
SMART
n=285 Participants
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=299 Participants
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Peak Expiratory Flow (PEF)
|
405.9 L/min
Interval 110.0 to 900.0
|
400.6 L/min
Interval 140.0 to 900.0
|
Adverse Events
SMART
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Conv. Best Practice
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SMART
n=326 participants at risk
Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
|
Conv. Best Practice
n=326 participants at risk
Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Musculoskeletal and connective tissue disorders
Epicondylitis
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Congenital, familial and genetic disorders
Gene Mutation
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Infections and infestations
Pneumonia
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Infections and infestations
Respiratory Tract Infection
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Eye disorders
Cataract
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Vascular disorders
Cerebral Haemorrhage
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
General disorders
Pyrexia
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Infections and infestations
Bursitis Infective
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
0.31%
1/326
The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place