Last reviewed · How we verify
Budesonide/formoterol and tiotropium
This combination reduces airway inflammation and constriction by combining a corticosteroid with two bronchodilators that work through different pathways.
This combination reduces airway inflammation and constriction by combining a corticosteroid with two bronchodilators that work through different pathways. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Budesonide/formoterol and tiotropium |
|---|---|
| Sponsor | Brian J Lipworth |
| Drug class | Combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist |
| Target | Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide is an inhaled corticosteroid that suppresses airway inflammation. Formoterol is a long-acting beta-2 agonist that relaxes airway smooth muscle. Tiotropium is a long-acting muscarinic antagonist that provides additional bronchodilation. Together, they address inflammation and bronchoconstriction through complementary mechanisms for sustained airway opening.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Hoarseness
Key clinical trials
- Asthma Research in Children and Adolescents
- Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (NA)
- Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- Mechanism(s) of Airflow Limitation During Exacerbation of Asthma (PHASE4)
- Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
- Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- Personalized Treatment Algorithms for Difficult-to-treat Asthma (PHASE2)
- Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD) (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:
- Budesonide/formoterol and tiotropium CI brief — competitive landscape report
- Budesonide/formoterol and tiotropium updates RSS · CI watch RSS
- Brian J Lipworth portfolio CI