Asthma, Bronchial
Conditions
Brief summary
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).
Interventions
DRUGSymbicort (budesonide/formoterol) Turbuhaler
DRUGConventional treatment
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9). * Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1. * Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA) * A history of suboptimal asthma control the month prior to enrolment as judged by the investigator * Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Exclusion criteria
* Previous treatment with Symbicort Single Inhaler; * Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment. * Known or suspected hypersensitivity to study therapy or excipients. * A history of smoking ≥ 10 pack years. * Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Severe Asthma Exacerbation | Baseline up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Severe Exacerbations | Baseline up to 6 months | 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 (GCS) treatment for at least 3 days. |
| Mean Use of as Needed Medication | Baseline up to 6 months | Mean use of as needed medication during the treatment period |
| Use of Inhaled Steroids | Baseline up to 6 months | Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents) |
| Change in the Asthma Control Questionnaire(ACQ) Score | Daily 14 days prior to each of visit 2-4 | The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled) |
| Peak Expiratory Flow (PEF) | 6 months (end of the study) | Peak expiratory flow (PEF) |
Countries
Spain
Participant flow
Recruitment details
654
Participants by arm
| Arm | Count |
|---|---|
| SMART Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms) | 328 |
| 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. | 326 |
| Total | 654 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Incorrect inclusion | 2 | 0 |
| Overall Study | Incorrect randomization | 0 | 1 |
| Overall Study | Lost to Follow-up | 12 | 8 |
| Overall Study | Protocol Violation | 7 | 4 |
| Overall Study | Several reasons | 17 | 15 |
| Overall Study | Withdrawal by Subject | 17 | 7 |
Baseline characteristics
| Characteristic | SMART | Conv. Best Practice | Total |
|---|---|---|---|
| Age Continuous | 43.7 Years STANDARD_DEVIATION 16.4 | 44.3 Years STANDARD_DEVIATION 16.5 | 44.0 Years STANDARD_DEVIATION 16.5 |
| Sex: Female, Male Female | 218 Participants | 202 Participants | 420 Participants |
| Sex: Female, Male Male | 110 Participants | 124 Participants | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 326 | 0 / 326 |
| serious Total, serious adverse events | 10 / 326 | 5 / 326 |
Outcome results
Primary
Time to First Severe Asthma Exacerbation
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.
Time frame: Baseline up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART | Time to First Severe Asthma Exacerbation | 174.39 Days | Standard Deviation 1.76 |
| Conv. Best Practice | Time to First Severe Asthma Exacerbation | 178.97 Days | Standard Deviation 1.86 |
Secondary
Change in the Asthma Control Questionnaire(ACQ) Score
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Time frame: Daily 14 days prior to each of visit 2-4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART | Change in the Asthma Control Questionnaire(ACQ) Score | 0.99 Scores on a scale | Full Range 0 |
| Conv. Best Practice | Change in the Asthma Control Questionnaire(ACQ) Score | 1.08 Scores on a scale | Full Range 0 |
Secondary
Mean Use of as Needed Medication
Mean use of as needed medication during the treatment period
Time frame: Baseline up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART | Mean Use of as Needed Medication | 1.03 Inhalations | Full Range 0 |
| Conv. Best Practice | Mean Use of as Needed Medication | 1.02 Inhalations | Full Range 0 |
Secondary
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF)
Time frame: 6 months (end of the study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SMART | Peak Expiratory Flow (PEF) | 405.9 L/min |
| Conv. Best Practice | Peak Expiratory Flow (PEF) | 400.6 L/min |
Secondary
Total Number of Severe Exacerbations
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 (GCS) treatment for at least 3 days.
Time frame: Baseline up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMART | Total Number of Severe Exacerbations | 24 Exacerbations |
| Conv. Best Practice | Total Number of Severe Exacerbations | 34 Exacerbations |
Secondary
Use of Inhaled Steroids
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Time frame: Baseline up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART | Use of Inhaled Steroids | 799 micrograms | Full Range 250 |
| Conv. Best Practice | Use of Inhaled Steroids | 1184 micrograms | Full Range 200 |