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

NCT05168995 | Completed

• 1 other identifier: CHIT-2101
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Control; PROs

Outcome Measures

Primary Outcomes (1)

• Improvement of asthma control level using the 5-item Asthma Control Questionnaire

  Proportion of patients improving the level of asthma control (based on ACQ-5 score). The ACQ-5 includes a measure of the top 5 asthma symptoms (woken at night by symptoms, day-time symptoms, limitation of daily activities, shortness of breath and wheeze) and the use of quick-relief bronchodilators. Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and use questions on a 7-point scale (0 = no impairment, 6 = maximum impairment). Patients' scores are then classified into three groups ('grouped scores') as having well-controlled asthma (ACQ-5 score ≤0.75); not well-controlled nor poorly controlled asthma (ACQ-5 score 0.75-1.5), or poorly controlled asthma (ACQ-5 score ≥1.5)

  6-month

Secondary Outcomes (8)

• Improvement of asthma control level using the 5-item Asthma Control Questionnaire

  3 months

• Achievement of minimal clinically important improvement in ACQ-5 score

  6 months

• Assessment of quality of life using EuroQol 5-dimension 5-level version (EQ-5D-5L)

  3 and 6 months

• Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)

  3 and 6 months

• Structured questions on patient satisfaction about the inhaler

  3 and 6 months

Study Arms (1)

Asthmatic patients in treatment with BDP/FF NEXThaler® 100/6 micrograms

Not adequately controlled asthmatic patients in treatment with Beclometasone dipropionate (BDP)/formoterol fumarate (FF) 100/6 micrograms per actuation inhalation powder via NEXThaler®

Drug: BDP/FF NEXThaler® 100/6 micrograms

Interventions

BDP/FF NEXThaler® 100/6 micrograms DRUG

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)

Asthmatic patients in treatment with BDP/FF NEXThaler® 100/6 micrograms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Not adequately controlled asthmatic adult patients (according to clinician's judgement)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Italia: lead

Study Sites (1)

Ospedale dell'Angelo

Mestre, VE, Italy

Location

Related Publications (1)

• 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.

  PMID: 40645348 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 23, 2021
• Study Start: April 12, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)