"Life-changing": the experience of super-responders to biologics in severe asthma.

Background: There is limited information on the patient's perspective of how biologic treatments impact their lives. We conducted a qualitative study to explore the patient's experience of being considered a super-responder from a quality of life perspective.

Methods: Patients with severe asthma identified as super-responders were invited to semi-structured interviews conducted online.

Preliminary development of a questionnaire to measure the extra-pulmonary symptoms of severe asthma.

Background: Research into the effects of asthma treatments on the extra-pulmonary symptoms of severe asthma is limited by the absence of a suitable questionnaire. The aim was to create a questionnaire suitable for intervention studies by selecting symptoms that are statistically associated with asthma pathology and therefore may improve when pathology is reduced.

Methods: Patients attending a specialist asthma clinic completed the 65-item General Symptom Questionnaire (GSQ-65), a questionnaire validated for assessing symptoms of people with multiple medically unexplained symptoms.

Comparison of the sensitivity of patient-reported outcomes for detecting the benefit of biologics in severe asthma.

BackgroundThe sensitivity of patient-reported outcomes (PROs) to detect the effects of treatment change depends on the match between the change in items of the PRO and the change that takes place in a sample of people. The aim of this study is to compare the sensitivity of different PROs in detecting changes following the initiation of biologic treatment in asthma. Patients starting a biologic treatment as part of clinical care completed the Asthma Control Questionnaire (ACQ-6), the Severe Asthma Questionnaire (SAQ and SAQ-global scores) and the EQ5D (EQ-5D-5L and EQ5D-VAS) at baseline.

Defining a Severe Asthma Super-Responder: Findings from a Delphi Process.

Background: Clinicians are increasingly recognizing severe asthma patients in whom biologics and other add-on therapies lead to dramatic improvement. Currently, there is no agreed-upon super-responder (SR) definition.

Objective: To survey severe asthma experts using a modified Delphi process, to develop an international consensus-based definition of a severe asthma SR.

The Severe Asthma Questionnaire: sensitivity to change and minimal clinically important difference.

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Validation of subscales of the Severe Asthma Questionnaire (SAQ) using exploratory factor analysis (EFA).

Background: The Severe Asthma Questionnaire (SAQ) is a health related quality of life (HRQoL) questionnaire validated for use in severe asthma. It is scored using the mean value of 16 items (SAQ score) in addition to a single item global rating of HRQoL (SAQ-global). The aim was to validate clinically relevant subscales using exploratory factor analysis (EFA).

Comparison of the effects of pulmonary and extra-pulmonary symptoms on health-related quality of life in patients with severe asthma.

Objectives: To survey the frequency of extra-pulmonary symptoms reported by a sample of patients with severe asthma, their contribution to quality of life and relationship to treatment pathways.

Methods: Consenting patients (N = 100) attending a severe asthma clinic completed questionnaire measures of extra-pulmonary symptoms (the General symptom Questionnaire, GSQ), pulmonary symptoms (Asthma Control Test, ACT), quality of life (the Severe Asthma Questionnaire, SAQ) and health status (EQ-5D-5L).

Results: A median of 21 extra-pulmonary symptoms were reported per week.

Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study.

Purpose: The goal of this study was to assess the long-term safety and efficacy of mepolizumab in patients with the most severe eosinophilic asthma.

Methods: This multicenter, open-label, long-term, Phase IIIb study (COSMEX [COSMOS Extension]; 201312/NCT02135692) enrolled patients from the 52-week, open-label extension study COSMOS (A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects) that previously enrolled patients from the double-blinded, placebo-controlled Phase III studies MENSA (Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma) and SIRIUS (Steroid Reduction with Mepolizumab Study). To enter COSMEX, patients had to have life-threatening/seriously debilitating asthma before entering MENSA or SIRIUS and to have completed these previous studies with demonstrated improvement while receiving mepolizumab.

Evidence for similarity in symptoms and mechanism: The extra-pulmonary symptoms of severe asthma and the polysymptomatic presentation of fibromyalgia.

Background: Asthma is a disease of the lung and a systemic disease. Functional disorders are associated with multiple systemic abnormalities that have been explained by complexity models. The aim was to test the similarity in type and aetiology between the extra-pulmonary symptoms of severe asthma and the symptoms of fibromyalgia.

The construction and validation of the Severe Asthma Questionnaire.

The US Food and Drug Administration's procedure for scale validation requires a documented stepwise process of qualitative and quantitative data. The aim of this paper is to provide final quantitative validating data for the Severe Asthma Questionnaire (SAQ).The SAQ, Asthma Control Test, Mini Asthma Quality of Life Questionnaire and EQ-5D-5L were completed by 160 patients attending a severe asthma clinic; 51 patients completed the SAQ on two occasions for test-retest reliability analysis.

How patient participation was used to develop a questionnaire that is fit for purpose for assessing quality of life in severe asthma.

Background: Previous research shows that existing asthma quality of life questionnaires fail to measure the burden of oral corticosteroids that can be used to treat severe asthma, and are therefore not fit for purpose for severe asthma according to the USA's Federal Drug Authority's (FDA) criteria for content validity. Patient input and documentation of that input is key to achieving content validity according to FDA guidelines. This paper describes the process of constructing a new questionnaire to measure the burden of asthma symptoms and burden of treatment in severe asthma, using criteria specified by the FDA.

Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study).

Objective: To describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS).

Design: A non-interventional, mixed methodology study, combining retrospective and prospective data collection for 12 months pre-omalizumab and post-omalizumab initiation, respectively.

Setting: Data were collected in 22 UK NHS centres, including specialist centres and district general hospitals in the UK.

A qualitative study of the impact of severe asthma and its treatment showing that treatment burden is neglected in existing asthma assessment scales.

Background: People with severe asthma experience significant respiratory symptoms and suffer adverse effects of oral corticosteroids (OCS), including disturbed mood and physical symptoms. OCS impacts on health-related quality of life (HRQoL) have not been quantified. Asthma HRQoL scales are valid as outcome measures for patients requiring OCS only if they assess the deficits imposed by OCS.

The use of the self-management plan system of care in adult asthma.

The development of self-management plans arose as clinicians tried to design better methods by which they could deliver asthma care and reduce the significant mortality and morbidity associated with this disease. The basic principles that resulted have been widely endorsed, and self-management plans are now recommended in the long-term management of adult asthma. Self-management plans essentially focus on the early recognition of unstable or deteriorating asthma, by monitoring peak flow or symptoms.

Fixed and adjustable dose asthma action plans based on combination therapy: a pilot study.

Objective: The use of combination inhaled corticosteroid/long-acting beta-agonist therapy within the framework of a self-management plan has yet to be investigated.

Methodology: In this randomized open-label study, 69 adult asthmatic patients taking >or= 1,000 microg per day of beclomethasone dipropionate (BDP) or equivalent were treated for 3 months with Symbicort Turbuhaler (200 microg budesonide/6 microg formoterol). Patients were assigned to one of two self-management plans, based on either a fixed or adjustable dose regimen.

The 24 h duration of bronchodilator action of the budesonide/formoterol combination inhaler.

Introduction: The duration of bronchodilator action of the long-acting beta-agonist formoterol when administered in the evening has not been investigated. In this study we have investigated whether a single evening dose of formoterol, administered from the combination budesonide/formoterol (BUD/F) Turbuhaler significantly attenuates the circadian rhythm in airway tone over 24 h.

Methods: Twenty subjects with mild to moderate asthma (mean FEV1 84% predicted) participated in a double-blind, placebo-controlled, cross-over study.

The 24 h duration of bronchodilator action of the salmeterol/fluticasone combination inhaler.

Introduction: The duration of bronchodilator action of the long-acting beta agonist salmeterol when administered in the evening has not been investigated. In this study we have investigated whether a single evening dose of salmeterol, administered from the combination salmeterol/fluticasone (SFC) Accuhaler significantly attenuates the circadian rhythm in airway tone over 24 h.

Methods: Eighteen subjects with mild to moderate asthma (mean FEV1 84% predicted) participated in a double-blind, double dummy, placebo controlled, cross-over study.