Last reviewed 2026-04-23 · How we verify

CHF 1535 Next DPI

CHF 1535 Next DPI is a dry powder inhaler for the treatment of cystic fibrosis.

CHF 1535 Next DPI is a dry powder inhaler for the treatment of cystic fibrosis. Used for Cystic fibrosis.

At a glance

Mechanism of action

It delivers a combination of lumacaftor and ivacaftor to the lungs, which work together to improve the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Approved indications

• Cystic fibrosis

Common side effects

• Upper respiratory tract infection
• Nausea
• Diarrhea

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

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