Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
budesonode+ terbutaline 'as needed' · 1 trial · 1 indication
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...
Budesonide + terbutaline 'as needed' is an investigational combination therapy being studied for the treatment of asthma in adults and adolescents. It combines a corticosteroid with a bronchodilator and is intended for use on an as-needed basis to manage asthma symptoms.
Budesonide + terbutaline 'as needed' combines two active ingredients: budesonide, a corticosteroid that reduces airway inflammation, and terbutaline, a bronchodilator that relaxes airway muscles. Together they target the underlying inflammation and bronchoconstriction associated with asthma.
Budesonide + terbutaline 'as needed' is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN.
Budesonide + terbutaline 'as needed' is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 4,215 participants.
Budesonide + terbutaline 'as needed' has been studied in a Phase 3 clinical trial registered as NCT02224157. This completed, randomized, double-blind, active-controlled study evaluated the combination used 'as needed' in adults and adolescents with asthma across multiple countries.
Budesonide + terbutaline 'as needed' is not the same as Symbicort. Symbicort contains budesonide and formoterol, while this investigational combination uses budesonide with terbutaline. The two products have different bronchodilator components and are distinct formulations.