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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: BDP/FF NEXThaler® 100/6 micrograms

• Study Type: Observational
• Enrollment (Actual): 620

Contacts and Locations

Study Locations

• Italy
  • VE
    • Mestre, VE, Italy
      • Ospedale dell'Angelo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male or female patients aged ≥18 years;
2. 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.
3. Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed;
4. Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®;
5. Written informed consent to participate in the study and for the processing of personal data.

Exclusion Criteria:

1. Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
2. Diagnosis of chronic obstructive pulmonary disease (COPD);
3. 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;
4. Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
5. Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months
Achievement of minimal clinically important improvement in ACQ-5 score	Proportion of patients achieving minimal clinically important improvement in ACQ-5 scores, as defined by ACQ-5 score decrease of at least 0.5 points	6 months
Assessment of quality of life using EuroQol 5-dimension 5-level version (EQ-5D-5L)	Change in EQ-5D-5L score. It consists of 2 pages, a descriptive system and a visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The VAS records the respondent's self-rated health on a 10 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.	3 and 6 months
Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)	Change in TAI-12 score. TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique).	3 and 6 months
Structured questions on patient satisfaction about the inhaler	Three questions related to the satisfaction for the device will be administered to patients who will express the grade of agreement. The 3 questions are scored on a 0-4 Likert scale, which range from 0 (completely unsatisfied) to 4 (completely satisfied), for a total maximum score of 12. Higher scores indicate a higher satisfaction with the inhaler.	3 and 6 months
Asthma exacerbations	Occurrence of moderate-to-severe exacerbations	6 months
Adverse events	Number of AEs	6 months
Adverse drug reactions to BDP/FF NEXThaler	Number of ADRs	6 months

Collaborators and Investigators

• Sponsor: Chiesi Italia

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Control; PROs
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: CHIT-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No