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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP/FF NEXThaler® 100/6 micrograms | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Achievement of minimal clinically important improvement in ACQ-5 score |
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Inclusion Criteria:
Exclusion Criteria:
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Not adequately controlled asthmatic adult patients (according to clinician's judgement)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale dell'Angelo | Mestre | VE | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40645348 | Result | Braido F, Beeh KM, Serrano CC, Dinh-Xuan AT, Tamasi L, Trofor A, Ingrassia E, Piraino A, Caruso C; NEWTON study group. Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler(R) and asthma control among adult asthmatic patients in Europe: The results of the Newton study. Respir Med. 2025 Oct;247:108224. doi: 10.1016/j.rmed.2025.108224. Epub 2025 Jul 9. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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
| 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'. | 3 and 6 months |
| Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12) | Change in TAI-12 score. TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique). | 3 and 6 months |
| Structured questions on patient satisfaction about the inhaler | Three questions related to the satisfaction for the device will be administered to patients who will express the grade of agreement. The 3 questions are scored on a 0-4 Likert scale, which range from 0 (completely unsatisfied) to 4 (completely satisfied), for a total maximum score of 12. Higher scores indicate a higher satisfaction with the inhaler. | 3 and 6 months |
| Asthma exacerbations | Occurrence of moderate-to-severe exacerbations | 6 months |
| Adverse events | Number of AEs | 6 months |
| Adverse drug reactions to BDP/FF NEXThaler | Number of ADRs | 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |