BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study

Figures & data

Box 1 Inclusion and Exclusion Criteria

Inclusion criteria

Male or female patients aged ≥18 years; Patients enrolled on the same day as the first prescription with beclometasone dipropionate (BDP)/formoterol fumarate dihydrate (FF) delivered through a dry-powder inhaler (DPI) 100/6 µg or having ongoing treatment with BDP/FF DPI 100/6 µg started within the previous 14 days (maximum), as per local standard clinical practice. In both cases, the physician’s decision to prescribe BDP/FF DPI 100/6 µg has been taken before the patient’s inclusion in the study and is completely independent of the study protocol; Inadequately controlled asthmatic patients (according to the clinician’s judgment) when BDP/FF DPI 100/6 µg was prescribed; Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF DPI; Written informed consent to participation in the study and processing of personal data.

Exclusion criteria

Recent (ie, within the last 6 months) history of life-threatening asthma exacerbations; Diagnosis of chronic obstructive pulmonary disease (COPD); Asthmatic patients on treatment with biological agents (eg, monoclonal antibodies) and/or extemporary or fixed triple combinations (eg, 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 the clinician’s judgment) or inability to understand and fill out the study questionnaires; Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months before enrollment into the present study.

Figure 1 NEWTON study plan and procedures.

Box 2 Study Objectives

Primary Objective

The study’s primary objective will be to evaluate the probability of improving patients’ asthma control status over 6 months using the 5-item version of the Asthma Control Questionnaire (ACQ-5) following treatment with BDP/FF DPI 100/6 µg.

Secondary Objectives

To describe the effects of BDP/FF DPI 100/6 µg on: Improvement of asthma control level at 3 months using the ACQ-5; Achievement of minimal clinically important improvement in ACQ-5 score at 6 months; Achievement of full asthma control at both 3 and 6 months using the ACQ-5 score; Change at 3 and 6 months from baseline in relevant lung function parameters; Change in quality of life at 3 and 6 months from baseline; Adherence to the most recent previous inhaled asthma treatment; Adherence to treatment at 3 and 6 months; Patient’s satisfaction with the inhaler at 3 and 6 months; Change in percentage of patients with high fractional exhaled nitric oxide values at 3 and 6 months from baseline; Incidence of asthma exacerbations over 6 months. To describe the safety of BDP/FF DPI 100/6 over 6 months.

Figure 2 NEWTON Italian sub-study plan and procedures.