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BDP/Formoterol Next DPI
BDP/Formoterol combines an inhaled corticosteroid (beclomethasone dipropionate) with a long-acting beta-2 agonist (formoterol) to reduce airway inflammation and improve bronchial smooth muscle relaxation.
BDP/Formoterol combines an inhaled corticosteroid (beclomethasone dipropionate) with a long-acting beta-2 agonist (formoterol) to reduce airway inflammation and improve bronchial smooth muscle relaxation. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | BDP/Formoterol Next DPI |
|---|---|
| Also known as | CHF 1535 NEXT DPI |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (beclomethasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Beclomethasone dipropionate is a corticosteroid that suppresses inflammatory responses in the airways by binding to glucocorticoid receptors, reducing cytokine production and immune cell infiltration. Formoterol is a long-acting beta-2 agonist that binds to beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and sustained airway opening. Together, this combination addresses both the inflammatory and obstructive components of asthma and COPD.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- VENTURI (VENTilation Using Respiratory Imaging) (PHASE2)
- Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients (PHASE1, PHASE2)
- Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI (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)
- Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients (PHASE2)
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/Formoterol Next DPI CI brief — competitive landscape report
- BDP/Formoterol Next DPI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI