Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ICS-LABA · 1 trial · 1 indication
To assess asthma exacerbation rate.
| Arm | Type | Description |
|---|---|---|
| Medium-dose ICS-LABA + benralizumab | ACTIVE_COMPARATOR | Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks. |
| High-dose ICS-LABA + placebo | ACTIVE_COMPARATOR | Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks. |
| Name | Type | Description |
|---|---|---|
| ICS-LABA | COMBINATION_PRODUCT | ICS-LABA inhalation |
| benralizumab | COMBINATION_PRODUCT | Benralizumab. SC injection. |
| Placebo for Benralizumab | COMBINATION_PRODUCT | Placebo for Benralizumab (aka, "placebo"). SC injection. |
Inclusion Criteria: * Written informed consent * Participant must be 12 to 75 years of age * Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 mon...
ICS-LABA is a combination therapy used in the treatment of eosinophilic asthma. It is being studied as a medium-dose treatment in patients with uncontrolled eosinophilic asthma, where it serves as the background therapy to which other add-on treatments are compared.
ICS-LABA is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the efficacy and safety of this treatment in patients with eosinophilic asthma.
ICS-LABA is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess its efficacy and safety in eosinophilic asthma.
ICS-LABA is being evaluated in a Phase 3 clinical trial with the identifier NCT06750289. This randomized, double-blind, active-controlled study is recruiting 400 participants across multiple countries, including the United States, Canada, China, and several European nations.
ICS-LABA is a combination of an inhaled corticosteroid and a long-acting beta-agonist. The corticosteroid reduces airway inflammation, while the long-acting beta-agonist helps to relax and open the airways. This dual mechanism is designed to improve asthma control in patients with eosinophilic asthma.