Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study

Svedsäter, Henrik; Jones, Rupert; Bosanquet, Nick; Jacques, Loretta; Lay-Flurrie, James; Leather, David; Vestbo, Jørgen; Collier, Susan; Woodcock, Ashley

doi:10.1016/j.rmed.2018.06.003

Cited by 18 publications

(18 citation statements)

References 23 publications

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“…In SLS asthma, several PRO effectiveness endpoints were prospectively assessed (including ACT, Asthma Quality of Life Questionnaire, Work Productivity and Impairment Questionnaire: Asthma, and the EuroQol 5-Dimensions 3-Levels questionnaire). Initiation of FF/VI was associated with consistent benefits in PROs versus continuing UC, demonstrating that the observed improvement in asthma control (measured by ACT) for FF/VI translates into patient-perceived benefits in health-related QoL [23]. Follow-up interview-based studies conducted in subsets of patients who completed SLS have also provided important additional findings on patient-centred outcomes relevant to respiratory care in routine clinical practice [24,32,33].…”

Section: How Might Sls Inform Hcps and Decision-makers?mentioning

confidence: 89%

“…In SLS asthma, the odds of patients being ACT responders (ACT total score C 20 and/or improvement from baseline C 3) at week 24 were significantly higher for FF/VI versus UC, without increased risk of SAEs [18]. Consistent benefit of FF/VI over UC has also been demonstrated for various other endpoints, as demonstrated in secondary analyses of SLS COPD and asthma [20][21][22][23][24][25][26][27][28][29].…”

Section: Safety Data Collectionmentioning

confidence: 97%

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Real-World Data and Randomised Controlled Trials: The Salford Lung Study

et al. 2020

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Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice. Pragmatic effectiveness trials measure the benefit a treatment produces in patients in everyday ''real-world'' practice. Ideally, effectiveness trials should recruit patients as similar as possible to those who will ultimately be prescribed the medicine, and create freedom within the study design to allow normal behaviours of patients and healthcare professionals (HCPs) to be expressed. The Salford Lung Study (SLS) was a world-first, prospective, phase III, pragmatic randomised controlled trial (RCT) programme in patients with chronic obstructive pulmonary disease and asthma to evaluate the effectiveness of a pre-licensed medication (fluticasone furoate/vilanterol) in real-world practice using electronic health records and through collaboratively engaging general practitioners and community pharmacists in clinical research. The real-world aspect of SLS was unique, requiring careful planning and attention to the goals of maximising the external validity of the Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11336171.

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Section: How Might Sls Inform Hcps and Decision-makers?mentioning

confidence: 89%

Section: Safety Data Collectionmentioning

confidence: 97%

Real-World Data and Randomised Controlled Trials: The Salford Lung Study

et al. 2020

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“…A study in the US showed that introduction of the Asthma APGAR tools for patients aged 5-45 in primary care improved rates of asthma control; reduced asthma-related urgent care, and hospital visits; and increased practices' adherence to asthma management guidelines. 69 Numerical 'asthma control' tools: these tools provide scores and cut points to distinguish different levels of symptom control, validated against health care provider assessment. Many translations are available.…”

Section: Asthma Symptom Control Tools For Adults and Adolescentsmentioning

confidence: 99%

Eficacia y seguridad de la inmunoterapia subcutánea para alérgenos inhalables en pacientes con alergia respiratoria a un año de tratamiento

Sánchez-Villalobos

Caballero-López

López-García

et al. 2021

RAM

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Antecedentes: La inmunoterapia específica con alérgenos es una importante modalidad terapéutica para el manejo de la rinitis y asma alérgica. Objetivo: Evaluar la eficacia y seguridad de la inmunoterapia subcutánea con alérgenos en pacientes con alergia respiratoria del Hospital Universitario de Puebla posterior a 12 meses de tratamiento. Métodos: Estudio longitudinal, secuencial, analítico, cuasiexperimental, prolectivo. Durante 12 meses se incluyeron pacientes con asma o rinitis, sensibilizados a aeroalérgenos, de cuatro a 65 años y de ambos sexos; bimensualmente se recolectaron los cuestionarios CARAT y Portnoy para evaluar la eficacia y seguridad, respectivamente. Resultados: Se incluyeron 47 pacientes, 37 (78.7 %) mujeres. La edad promedio fue de 29.8 años. El 76.6 % tuvo diagnóstico de rinitis alérgica y 23.4 % de asma y rinitis alérgica. Al comparar el promedio del CARAT inicial contra el promedio final mediante prueba de t de Student se obtuvo un valor de –8.86 y p < 0.05. Se reportó una frecuencia total de reacciones adversas locales de 19 % y de reacciones adversas sistémicas de 2.1 % a los seis y 12 meses del tratamiento. Conclusiones: El esquema de inmunoterapia evaluado, derivado de la Guía Mexicana de Práctica Clínica de Inmunoterapia 2011, es eficaz con un conveniente perfil de seguridad.

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“…Новые результаты SLS-Asthma опубликованы в августе 2018 г. в журнале «Respiratory Medicine» [24]. Так, проведен анализ влияния ВИ / ФФ на симптомы БА и другие компоненты АСТ, в т. ч. одышку и пробуждения ночью или ранним утром из-за БА.…”

Section: таблица 3 распределение больных бронхиальной астмой в зависиunclassified

Asthma control: actual problems and solutions in real clinical practice

Лещенко

2019

Pulʹmonologiâ (Mosk.)

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Asthma control is still difficult to achieve. One of main tools for evaluating asthma control is a well-known Asthma Control Test (ACT). Common causes of insufficient asthma control include poor adherence to treatment and non-compliance of the patient with the dosing regimen. Correct inhalation technique significantly contributes to better adherence to treatment. Elliptа is a multi-dose powder inhaler with dose counter and indication of remaining dose number. Actuation of Ellipta inhaler requires only one movement. Inhaled glucocorticosteroids (ICS) and long-acting β2-agonists (LABA) are the key agents in the maintenance pharmacological therapy of asthma. A novel vilanterol/fluticasone furoate (VI/FF) combination is a highly effective combination for maintenance treatment of moderate to severe asthma with 24-hour effect providing once-daily dosing. The Salford study demonstrated advantages of VI/FF combination over ICS monotherapy and other combination of ICS/LABA in real clinical practice in patients with asthma out of dependence of asthma severity or comorbidities.

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Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study

Abstract: Initiation of FF/VI versus continuing UC was associated with consistent improvements in PROs.

Cited by 18 publications

References 23 publications

Real-World Data and Randomised Controlled Trials: The Salford Lung Study

Real-World Data and Randomised Controlled Trials: The Salford Lung Study

Eficacia y seguridad de la inmunoterapia subcutánea para alérgenos inhalables en pacientes con alergia respiratoria a un año de tratamiento

Asthma control: actual problems and solutions in real clinical practice

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