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Aclidinium bromide/formoterol fumarate combination
Aclidinium bromide and formoterol fumarate work together as a long-acting anticholinergic and long-acting beta-2 agonist to relax airway smooth muscle and improve airflow in chronic obstructive pulmonary disease.
Aclidinium bromide and formoterol fumarate work together as a long-acting anticholinergic and long-acting beta-2 agonist to relax airway smooth muscle and improve airflow in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | Aclidinium bromide/formoterol fumarate combination |
|---|---|
| Also known as | Duaklir™ Genuair®, DUAKLIR™ GENUAIR® |
| Sponsor | AstraZeneca |
| Drug class | Long-acting anticholinergic/long-acting beta-2 agonist combination (LAMA/LABA) |
| Target | Muscarinic M3 receptor and beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Aclidinium bromide is a muscarinic M3 receptor antagonist that blocks acetylcholine-induced bronchoconstriction, while formoterol fumarate is a beta-2 adrenergic agonist that stimulates bronchodilation. Together, these complementary mechanisms provide sustained bronchodilation and improved lung function in COPD patients. The combination allows for twice-daily dosing with enhanced efficacy compared to monotherapy.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nasopharyngitis
- Cough
Key clinical trials
- Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients (PHASE3)
- 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)
- Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE2)
- DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
- AMPLIFY - D6571C00001 Duaklir USA Phase III Study (PHASE3)
- Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients (PHASE4)
- A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)
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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