Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02224157 | A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma | PHASE3 | COMPLETED | 4,215 | — | — | Nov 28, 2014 | Aug 16, 2017 | Nov 25, 2019 | 340 | Australia, Brazil +23 |
Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
| Arm | Type | Description |
|---|---|---|
| Symbicort "as needed"+placebo Pulmicort bid | EXPERIMENTAL | Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid |
| Pulmicort bid + terbutaline "as needed" | ACTIVE_COMPARATOR | Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed' |
| Name | Type | Description |
|---|---|---|
| budesonide/formoterol 'as needed' + budesonide placebo bid | DRUG | Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
| budesonode bid + terbutaline 'as needed' | DRUG | Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6...