NCT05168995Completed
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 620 (actual)
- First submitted
- 10 Dec 2021
- Start date
- 12 Apr 2022
- Primary completion date
- 9 Feb 2024
- Lead sponsor
- Chiesi Italia
- Diseases
- Asthma
- NCT number
- NCT05168995
What you commit to
- Study type: Observational
- Participants enrolled: 620
- From 12 Apr 2022 to the primary completion date, 9 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.
Other illness
- Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
- Diagnosis of chronic obstructive pulmonary disease (COPD);
- Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale dell'Angelo Coordinator of this site? Confirm its status | Mestre | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.