AzTrials
AzTrials

AsthmaNEWTONNCT05168995

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

An observational study of Asthma, run by Chiesi Italia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
BDP/FF NEXThaler® 100/6 micrograms
How many people
620 participants
Where
1 siteItaly
Study dates
12 Apr 2022to 9 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale dell'Angelo

    Mestre, VE

Other trials in Italy

About this study

Official title: 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.

Conditions
Asthma
Being tested
BDP/FF NEXThaler® 100/6 micrograms
Keywords
Control, PROs
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDP/FF NEXThaler® 100/6 microgramsDrug

    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)

Study groups in NCT05168995
Study groupRoleWhat they receive
Asthmatic patients in treatment with BDP/FF NEXThaler® 100/6 microgramsNot adequately controlled asthmatic patients in treatment with Beclometasone dipropionate (BDP)/formoterol fumarate (FF) 100/6 micrograms per actuation inhalation powder via NEXThaler®
Receives: Drug: BDP/FF NEXThaler® 100/6 micrograms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6-month

Secondary outcomes (8)

  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)

    Measured: 3 months

  2. 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

    Measured: 6 months

  3. 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'.

    Measured: 3 and 6 months

  4. 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).

    Measured: 3 and 6 months

  5. 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.

    Measured: 3 and 6 months

  6. Asthma exacerbations

    Occurrence of moderate-to-severe exacerbations

    Measured: 6 months

  7. Adverse events

    Number of AEs

    Measured: 6 months

  8. Adverse drug reactions to BDP/FF NEXThaler

    Number of ADRs

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start12 Apr 2022
  3. Primary completion9 Feb 2024
  4. Study completion9 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168995
Sponsor's protocol ID
CHIT-2101
Acronym
NEWTON
Status last verified
Sep 2026
First submitted
10 Dec 2021
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40645348

  • Baiardini I, Caruso C, Castellani W, Ricci A, Michieletto L, Calabrese C, Ingrassia E, Piraino A, Simoni L, Ori A, Braido F; NEWTON study group. Psychometric Validation of the Speed of Change in Feeling of Health (SCFH) Questionnaire: Findings from the NEWTON Sub-Study in Italian Asthma Patients. Patient Relat Outcome Meas. 2026 Apr 23;16:543501. doi: 10.2147/PROM.S543501. eCollection 2025.

    PubMed 42052244

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Chiesi Italia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of asthma control level using the 5-item Asthma Control Questionnaire (time frame: 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168995, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in