AB039. Pragmatic trial stepping down Flutiform® in patients maintained on high dose ICS
Notice bibliographique
Résumé
Background: Global Initiative for Asthma (GINA) guidelines recommend a gradual step-down of asthma therapy if asthma has been well-controlled for at least 3 months. In real life, however, many well-controlled patients are prescribed high doses of inhaled corticosteroids (ICS), and are therefore unnecessarily at risk of systemic side effects associated with long-term ICS use. To encourage and facilitate step-down in a clinical setting, further pragmatic studies are required to demonstrate that good control of asthma can be maintained with a lower dose of ICS in stable and controlled patients, and to explore potential predictors for response to step-down.To test if good control of asthma can be maintained in adult patients previously stable on Flutiform® 250 (250 mcg fluticasone/10 mcg formoterol) for 12 weeks, after step-down to Flutiform® 125 (250 mcg fluticasone/5 mcg formoterol). Methods: This was the second phase of a pragmatic, open-label, randomised controlled, non-inferiority trial in adult patients with asthma. Patients eligible for this phase had been on Flutiform® 250 for 12 weeks, had had no exacerbations during this period and were considered suitable for step-down by their GP. A total of 116 patients from 23 sites in the UK were randomised 1:1 to continue on Flutiform® 250 or to step down to Flutiform® 125. The primary outcome was asthma control assessed using the 7-item Asthma Control Questionnaire (ACQ7). Non-inferiority limit on the ACQ7 was set at 0.3. Patients were eligible for the non-inferiority analysis if they stayed on the randomised treatment for at least 8 weeks and did not change treatment before outcome visit. Secondary outcomes included forced expiratory volume in the first second (FEV1) % predicted, the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), asthma control (according to GINA) and absence of exacerbations during outcome period. Analyses of secondary outcomes included all randomised patients [Full Analysis Set (FAS)]. Adherence was calculated based on dose counter values for patients who returned the study inhalers. Results: Of the 107 patients who completed the study 48 (45%) were male and the mean [standard deviation (SD)] age was 54 (13) years. Of those randomised, 52 (90%) patients in each arm were eligible for the non-inferiority analysis (see figure for details of the FAS). At week 12, Flutiform® 125 was non-inferior to Flutiform® 250 in terms of asthma control assessed by ACQ7, with an upper confidence limit of 0.22, which is less than the pre-defined limit of 0.3 [mean difference 0.01; 95% confidence interval (CI), −0.20 to 0.22]. No significant differences between the groups were found for GINA asthma control, absence of exacerbations, Mini-AQLQ, or FEV1% predicted (see Table for treatment effect estimates). Adherence was high in both groups [median (inter-quartile range) 94% (88% to 106%) and 98% (77% to 103%) for the Flutiform® 125 and Flutiform® 250 groups, respectively] and there was no significant difference in distribution of adherence between the groups (P=0.20, Mann-Whitney U-test). Conclusions: This study showed that real-life patients previously controlled on Flutiform® 250 can be stepped down to Flutiform® 125 and maintain good asthma control. Additional analyses are ongoing to investigate biomarkers [blood eosinophils, fractional exhaled nitric oxide (FeNO)] and other factors that might predispose patients to exacerbations or worsening of asthma control following ICS step-down. In the future, such predictors could help physicians to make more informed decisions on stepping down therapy in a real-life setting.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,004 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,016 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».