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Budesonide-Formoterol treatment
Budesonide-formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle to improve breathing.
Budesonide-formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance and reliever therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Budesonide-Formoterol treatment |
|---|---|
| Also known as | Budesonide 160 μg/formoterol 4.5 μg treatment |
| Sponsor | AstraZeneca |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide is an inhaled corticosteroid that suppresses inflammatory responses in the airways by binding glucocorticoid receptors, reducing mucus production and airway edema. Formoterol is a long-acting beta-2 adrenergic agonist (LABA) that binds beta-2 receptors on airway smooth muscle, causing bronchodilation and improved airflow. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance and reliever therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
- Muscle cramps
Key clinical trials
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
- Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
- Ventilation and Perfusion in Asthmatics (PHASE4)
- A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Budesonide-Formoterol treatment CI brief — competitive landscape report
- Budesonide-Formoterol treatment updates RSS · CI watch RSS
- AstraZeneca portfolio CI