NCT05168995

Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma Control

Effects of Beclometasone Dipropionate/Formoterol Fumarate Fixed Combination Administered With the NEXT(Haler) in a Real-world Study on the Probability of Improving the Asthma Control Status After 6 Months of Treatment. The NEWTON Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 620 (actual)
• Sponsor: Chiesi Italia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of asthma management is to achieve and maintain optimal asthma control. The NEWTON study assesses the evolution over time of patient reported outcomes (PROs) in asthmatic patients, not adequately controlled with ongoing treatments and initiating therapy with extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) via NEXThaler.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BDP/FF NEXThaler® 100/6 micrograms	BDP/FF NEXThaler® 100/6 maintenance treatment: one or two inhalations twice daily (one inhalation in the morning and one inhalation in the evening). BDP/FF NEXThaler® 100/6 maintenance and reliever treatment (MART)

Timeline

• Start date: 2022-04-12
• Primary completion: 2024-02-09
• Completion: 2024-02-09
• First posted: 2021-12-23
• Last updated: 2026-02-20

Locations

1 site across 1 country: Italy