CompletedNot Applicable

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

Italy620 participantsStarted 2022-04-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: 6-month

Trial details

NCT IDNCT05168995

SponsorChiesi Italia

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-09

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