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Also known as BDA MDI
Albuterol/budesonide · 1 trial · 1 indication
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Budesonide/albuterol metered -dose inhaler (BDA MDI) | EXPERIMENTAL | Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed. |
| Albuterol sulfate metered-dose inhaler (AS MDI) | ACTIVE_COMPARATOR | Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed. |
| Name | Type | Description |
|---|---|---|
| BDA MDI | COMBINATION_PRODUCT | Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed. |
| AS MDI | COMBINATION_PRODUCT | Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed. |
Inclusion Criteria: * Confirmed clinical diagnosis of asthma at least 12 months. * Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month 1. Low-to-high-dose Inhaled corticosteroid(s) (ICS) 2. Low-to-high-d...
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 |
Albuterol/budesonide is an investigational inhaled combination therapy being developed for the treatment of asthma. It is designed to be used as needed in patients with asthma. It combines a short-acting bronchodilator with an inhaled corticosteroid in a single metered dose inhaler.
Albuterol/budesonide targets the beta-2 adrenergic receptor, known as ADRB2, as an agonist. Albuterol acts as a short-acting beta-2 agonist to relax airway smooth muscle, while budesonide is an inhaled corticosteroid that reduces airway inflammation. Together they address both bronchoconstriction and inflammation in asthma.
Albuterol/budesonide is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is advancing the combination as a potential treatment for asthma.
Albuterol/budesonide is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The ongoing Phase 3 trial is evaluating its efficacy and safety in adolescents with asthma.
Albuterol/budesonide is being studied in the Phase 3 trial NCT06307665, titled Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma. The trial is currently recruiting and plans to enroll 440 participants across the United States, China, Mexico, and South Africa.
Yes, albuterol/budesonide is also known as BDA MDI. BDA MDI refers to the same investigational fixed-dose combination product being developed by AstraZeneca for asthma.