Clinical trial NCT05168995: Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma Control
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Control
PROs
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Not adequately controlled asthmatic adult patients (according to clinician's judgement)

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.


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.

Primary outcomes:
measure: Improvement of asthma control level using the 5-item Asthma Control Questionnaire
timeFrame: 6-month
Secondary outcomes:
measure: Improvement of asthma control level using the 5-item Asthma Control Questionnaire
timeFrame: 3 months
measure: Achievement of minimal clinically important improvement in ACQ-5 score
timeFrame: 6 months
measure: Assessment of quality of life using EuroQol 5-dimension 5-level version (EQ-5D-5L)
timeFrame: 3 and 6 months
measure: Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)
timeFrame: 3 and 6 months
measure: Structured questions on patient satisfaction about the inhaler
timeFrame: 3 and 6 months
measure: Asthma exacerbations
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Adverse drug reactions to BDP/FF NEXThaler
timeFrame: 6 months
Other outcomes:
Locations:
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: VE
Study officials:
References: