Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
terbutaline 'as needed'+ placebo budesonide · 1 trial · 1 indication
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
| 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 |
| terbutaline "as needed"+placebo Pulmicort bid | ACTIVE_COMPARATOR | terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler 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 |
| terbutaline 'as needed' + placebo budesonide bid | DRUG | Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
| budesonide 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 m...
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 | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, 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 |
This treatment regimen was studied in asthma in adults and adolescents aged 12 years and older. It combined as-needed terbutaline with placebo budesonide given twice daily, and it was evaluated as a comparator arm in a Phase 3 asthma study.
AstraZeneca PLC, which trades under the ticker AZN, is the developer associated with this treatment regimen. The company sponsored the Phase 3 asthma study that evaluated as-needed terbutaline combined with placebo budesonide administered twice daily.
This regimen has been studied in a Phase 3 clinical trial in asthma. That trial has completed, and no trials of this regimen are currently active. It is an investigational comparator regimen rather than an approved standalone product.
The regimen was evaluated in NCT02149199, titled A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. The Phase 3 trial enrolled 3,850 participants, was randomized, double blind, and active controlled, and has completed.
NCT02149199 enrolled participants across Australia, Brazil, Bulgaria, Canada, Chile, China, Hungary, Mexico, Peru, the Philippines, Poland, Romania, Russia, South Africa, South Korea, Ukraine, the United Kingdom, and Vietnam. It included adults and adolescents aged 12 years and older with asthma and did not enroll healthy volunteers.