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Beclomethasone plus formoterol fixed combination
Beclomethasone (a corticosteroid) reduces airway inflammation while formoterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing.
Beclomethasone (a corticosteroid) reduces airway inflammation while formoterol (a long-acting beta-2 agonist) relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Beclomethasone plus formoterol fixed combination |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination |
| Target | Glucocorticoid receptor (beclomethasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Beclomethasone acts as a glucocorticoid receptor agonist that suppresses inflammatory cytokine production and immune cell recruitment in the airways. Formoterol is a beta-2 adrenergic receptor agonist that increases intracellular cAMP, causing bronchial smooth muscle relaxation and bronchodilation. Together, this combination addresses both the inflammatory and obstructive components of asthma and COPD.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)
- Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma Control
- Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
- A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (PHASE3)
- A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (PHASE3)
- Asthma Research in Children and Adolescents
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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