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

NCT ID: NCT05168995

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 620 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2024-02-09

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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®

BDP/FF NEXThaler® 100/6 micrograms

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Italia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale dell'Angelo

Mestre, VE, Italy

Countries

Italy

Other Identifiers

CHIT-2101

Identifier Type: -

Identifier Source: org_study_id