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

Study Identifier:
CHIT-2101
ClinicalTrials.gov Identifier:
NCT05168995
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Scientific Result Summary
Available Languages: English
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Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: BDP/FF NEXThaler® 100/6 micrograms
Date
Apr 2022 - Feb 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male or female patients aged ≥18 years;
  • Patients enrolled on the same day as the first prescription with BDP/FF NEXThaler® 100/6 micrograms, or having ongoing treatment with BDP/FF NEXThaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice.
  • Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed;
  • Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®;
  • Written informed consent to participate in the study and for the processing of personal data.
Exclusion Criteria
  • Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
  • Diagnosis of chronic obstructive pulmonary disease (COPD);
  • Asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA)/inhaled corticosteroid (ICS) at any dose regimen;
  • Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
  • Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Ospedale dell'Angelo
Mestre, VE, Italy
Status
N/A

Study Publications

Braido F, Beeh KM, Serrano CC, Dinh-Xuan AT, Tamasi L, Trofor A, Ingrassia E, Piraino A, Caruso C; NEWTON study group. Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler(R) and asthma control among adult asthmatic patients in Europe: The results of the Newton study. Respir Med. 2025 Oct;247:108224. doi: 10.1016/j.rmed.2025.108224. Epub 2025 Jul 9.