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Symbicort 160/4.5 pMDI
Symbicort combines an inhaled corticosteroid (budesonide) and a long-acting beta-2 agonist (formoterol) to reduce airway inflammation and dilate airways.
Symbicort combines an inhaled corticosteroid (budesonide) and a long-acting beta-2 agonist (formoterol) to reduce airway inflammation and dilate airways. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | Symbicort 160/4.5 pMDI |
|---|---|
| Also known as | Symbicort = budesonide plus formoterol fumarate |
| Sponsor | Allergy and Asthma Center of El Paso |
| 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 suppresses inflammatory responses in the airways by binding glucocorticoid receptors, reducing mucus production and airway edema. Formoterol activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and improving airflow. Together, they provide both anti-inflammatory and bronchodilator effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance treatment
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Nervousness
- Oral candidiasis
- Palpitations
- Muscle cramps
Key clinical trials
- Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (PHASE3)
- Anti-Inflammatory Reliever South Africa (PHASE3)
- Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (PHASE3)
- Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing (PHASE4)
- Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (PHASE3)
- Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus) (PHASE4)
- A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers (PHASE1)
- Phase IV O2 Consumption Study in COPD Patients. (PHASE4)
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:
- Symbicort 160/4.5 pMDI CI brief — competitive landscape report
- Symbicort 160/4.5 pMDI updates RSS · CI watch RSS
- Allergy and Asthma Center of El Paso portfolio CI