Asthma
Conditions
Keywords
Asthma, Alvesco®, Ciclesonide
Brief summary
The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.
Interventions
DRUGCiclesonide
Asthma Care with Alvesco
DRUGUsual Care Inhaled Glucocorticosteroids
Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid 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
Main inclusion criteria: * Written informed consent * 18 years or older with diagnosis of asthma for at least 6 months * Clinically stable asthma at the time of study enrollment * Clinical requirements for treatment with ICS as outlined in the Canadian Asthma Consensus Guidelines * If patients are currently on ICS, the dose must be stable for 3 months and they must be willing to switch Main
Exclusion criteria
* On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy * Severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids * Mild asthma requiring short acting beta-2-agonists only * Patients with a contraindication to ICS therapy * Any other disease or medical condition requiring further clinical evaluation, which in the opinion of the Primary Care Practitioner may interfere with the clinical study or interfere with the diagnosis of asthma. * Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) | At the middle and end of the 12 week treatment period | The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Assessment of Asthma Control | At baseline and at week 12 | Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement. |
| Assessment of Patient Compliance During the Study | 12 weeks | — |
| Assessment of Patient Treatment Satisfaction | 12 weeks | — |
Countries
Canada
Participant flow
Pre-assignment details
The number of subjects STARTED is related to the number of randomized subjects (= subjects who were eligible for treatment period). It differs from the number of subjects of the Intention to Treat (ITT) population in Baseline Characteristics and Outcome Measures. The statistical analyses of the Outcome Measures is based on the ITT population.
Participants by arm
| Arm | Count |
|---|---|
| Alvesco 320 mcg/day or 640 mcg/day | 712 |
| Usual Asthma Care and Dosage as chosen by the Primary Care Physician | 345 |
| Total | 1,057 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 39 | 6 |
| Overall Study | Lack of compliance | 5 | 1 |
| Overall Study | Lost to Follow-up | 20 | 9 |
| Overall Study | Other | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Reason not stated | 3 | 6 |
| Overall Study | Withdrawal by Subject | 19 | 2 |
Baseline characteristics
| Characteristic | Alvesco | Usual Asthma Care and Dosage | Total |
|---|---|---|---|
| Age, Customized | 47.3 years STANDARD_DEVIATION 16.3 | 47.2 years STANDARD_DEVIATION 16.7 | 47.26 years STANDARD_DEVIATION 16.43 |
| Duration of Asthma | 12.4 years STANDARD_DEVIATION 11.3 | 12.8 years STANDARD_DEVIATION 11.9 | 12.5 years STANDARD_DEVIATION 11.4 |
| Gender Female | 431 Participants | 232 Participants | 663 Participants |
| Gender Male | 281 Participants | 113 Participants | 394 Participants |
| Smoking Status Current | 156 participants | 81 participants | 237 participants |
| Smoking Status Former | 197 participants | 115 participants | 312 participants |
| Smoking Status Never | 359 participants | 149 participants | 508 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 741 | 0 / 346 |
| serious Total, serious adverse events | 6 / 741 | 1 / 346 |
Outcome results
Primary
Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)
The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).
Time frame: At the middle and end of the 12 week treatment period
Population: Basis is the ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alvesco | Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) | -0.76 points on a scale | Standard Deviation 0.97 |
| Usual Asthma Care and Dosage | Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) | -0.37 points on a scale | Standard Deviation 0.98 |
Comparison: This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.p-value: <0.0001t-test, 2 sided
Secondary
Assessment of Patient Compliance During the Study
Time frame: 12 weeks
Secondary
Assessment of Patient Treatment Satisfaction
Time frame: 12 weeks
Secondary
Change in Patient Assessment of Asthma Control
Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement.
Time frame: At baseline and at week 12
Population: Basis is the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alvesco | Change in Patient Assessment of Asthma Control | Improvement | 422 participants |
| Alvesco | Change in Patient Assessment of Asthma Control | Non-Improvement | 284 participants |
| Alvesco | Change in Patient Assessment of Asthma Control | Not reported | 6 participants |
| Usual Asthma Care and Dosage | Change in Patient Assessment of Asthma Control | Improvement | 132 participants |
| Usual Asthma Care and Dosage | Change in Patient Assessment of Asthma Control | Non-Improvement | 209 participants |
| Usual Asthma Care and Dosage | Change in Patient Assessment of Asthma Control | Not reported | 4 participants |