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CHF1535 NEXT DPI
CHF1535 is a dual bronchodilator combining an inhaled corticosteroid with a long-acting beta-2 agonist and long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease.
CHF1535 is a dual bronchodilator combining an inhaled corticosteroid with a long-acting beta-2 agonist and long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | CHF1535 NEXT DPI |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | ICS/LABA/LAMA combination |
| Target | Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 2 |
Mechanism of action
CHF1535 NEXT DPI is a triple-component fixed-dose combination delivered via dry powder inhaler that combines an inhaled corticosteroid (ICS) with dual bronchodilators—a long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA). This combination provides anti-inflammatory and bronchodilatory effects to improve airflow and reduce exacerbations in COPD patients.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Cough
Key clinical trials
- 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)
- Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old (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)
- Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients (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 |