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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Budesonide plus terbutaline 'as needed' is an asthma treatment studied for use on an as-needed basis in adults and adolescents aged 12 years and older. It combines an inhaled corticosteroid with a rapid-acting bronchodilator in a single inhaler, taken when symptoms occur rather than on a fixed daily schedule.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of budesonide plus terbutaline 'as needed'. The company sponsored the Phase 3 study of this as-needed dosing approach in asthma.
Budesonide plus terbutaline 'as needed' has been evaluated in Phase 3 clinical development for asthma. The single Phase 3 trial of this as-needed regimen is completed, and no trials of this regimen are currently active.
The Phase 3 trial NCT02224157, titled a clinical study to evaluate Symbicort Turbuhaler used 'as needed' in adults and adolescents with asthma, evaluated this regimen. It enrolled 4,215 participants across 25 countries, was randomized, double blind, and active controlled, and has completed.
The Phase 3 trial NCT02224157 enrolled 4,215 participants, all aged 12 years or older, with asthma. Enrollment spanned 25 countries including Australia, Brazil, Germany, France, Spain, South Korea, and others. The study was randomized, double blind, and active controlled, and it has completed.