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

Chiesi Italia620 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

620

Conditions

Asthma

Interventions

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale dell'Angelo

Mestre, VE, Italy

Outcomes

Primary Outcomes

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)

Time frame: 6-month

Secondary Outcomes

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)

Time frame: 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

Time frame: 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'.

Data from ClinicalTrials.gov

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