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Budesonide + Salmeterol + Montelukast
This combination reduces airway inflammation via corticosteroid action, dilates airways through beta-2 agonist stimulation, and blocks leukotriene-mediated inflammatory pathways.
This combination reduces airway inflammation via corticosteroid action, dilates airways through beta-2 agonist stimulation, and blocks leukotriene-mediated inflammatory pathways. Used for Persistent asthma in patients not adequately controlled on inhaled corticosteroid and long-acting beta-2 agonist alone, Asthma with allergic or exercise-induced components.
At a glance
| Generic name | Budesonide + Salmeterol + Montelukast |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Combination therapy: inhaled corticosteroid + long-acting beta-2 agonist + leukotriene receptor antagonist |
| Target | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (salmeterol); cysteinyl leukotriene receptors CysLT1 and CysLT2 (montelukast) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide is an inhaled corticosteroid that suppresses inflammatory cytokines and immune cell recruitment in the airways. Salmeterol is a long-acting beta-2 agonist that relaxes bronchial smooth muscle and provides sustained bronchodilation. Montelukast is a cysteinyl leukotriene receptor antagonist that blocks inflammatory mediators involved in asthma pathogenesis, providing complementary anti-inflammatory and bronchodilatory effects.
Approved indications
- Persistent asthma in patients not adequately controlled on inhaled corticosteroid and long-acting beta-2 agonist alone
- Asthma with allergic or exercise-induced components
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Oral candidiasis
- Palpitations
- Muscle cramps
Key clinical trials
- Asthma Research in Children and Adolescents
- Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS) (PHASE4)
- DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults (PHASE3)
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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