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BDP DPI and formoterol DPI
This combination inhaler delivers beclomethasone dipropionate (a corticosteroid) and formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation in obstructive airway diseases.
This combination inhaler delivers beclomethasone dipropionate (a corticosteroid) and formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation in obstructive airway diseases. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | BDP DPI and formoterol DPI |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (BDP); Beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 2 |
Mechanism of action
Beclomethasone dipropionate acts as a topical corticosteroid that suppresses inflammatory responses in the airways by inhibiting cytokine production and immune cell recruitment. Formoterol is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle, causing bronchodilation and improved airflow. Together, they provide both anti-inflammatory and bronchodilatory effects via dry powder inhalation.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- VENTURI (VENTilation Using Respiratory Imaging) (PHASE2)
- Functional Respiratory Imaging Study (PHASE3)
- A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients (PHASE2)
- Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients (PHASE1, PHASE2)
- Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder (PHASE2)
- Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients. (PHASE2)
- A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BDP DPI and formoterol DPI CI brief — competitive landscape report
- BDP DPI and formoterol DPI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI