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Budesonide/Formoterol SPIROMAX®
Budesonide/Formoterol combines an inhaled corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.
Budesonide/Formoterol combines an inhaled corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle. Used for Asthma maintenance and reliever therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Budesonide/Formoterol SPIROMAX® |
|---|---|
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination |
| Target | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Budesonide is a corticosteroid that suppresses inflammatory responses in the airways by binding to glucocorticoid receptors, reducing mucus production and airway edema. Formoterol is a long-acting beta-2 adrenergic agonist (LABA) that activates beta-2 receptors on airway smooth muscle, causing bronchodilation and improved airflow. The combination provides 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
Key clinical trials
- Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma (PHASE3)
- Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER® (PHASE3)
- Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment
- Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD (PHASE3)
- Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD (NA)
- Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices (NA)
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 |
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