Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

Background: The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy. Objective: Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab. Methods: Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non-oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT. Results: For non-OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT. Conclusions: These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction

Health-related quality of life in young adults with asthma

Background: The aim was to study health-related quality of life, five years after an intervention study among young adults with asthma. Method: The design was a follow-up study of a cohort of young adults with asthma (n = 64) and 248 general, population controls. Both groups were investigated at follow-up with a respiratory questionnaire and one generic quality-of-life instrument, and the asthma cohort also completed one-asthma-specific questionnaire. The material was analyzed with multivariate models. Results: Female gender and tow FEV1 at baseline predicted both a decline during follow-up and a tow quality of life at follow-up. The asthma cohort and controls scored similarly regarding generic quality of life. However, in the asthma cohort, females scored significantly lower in the physical dimension of the generic instrument, especially in the domain of general, health. Conclusions: There is an association between tow FEV1 and a decline in quality of life among young adults with asthma, i.e. low FEV1 predicts a decline in quality of life during a five-year period. Young females with asthma seem to have lower quality of life compared with young mates with asthma. (C) 2009 Elsevier Ltd. All rights reserved

Patient perspectives on living with severe asthma in Denmark and Sweden

Background: Severe asthma has an acknowledged impact on health-related quality of life (HRQOL) and is associated with substantial health care costs. This study aimed to investigate the patients’ own experiences of the disease, perceptions of HRQOL, and awareness of disease management. Methods: This study included severe asthma patients in Sweden and Denmark. A quantitative Web-based survey and qualitative in-depth interviews (IDIs) were conducted. The survey included St. George’s Respiratory Questionnaire (SGRQ), Asthma Control Test (ACT), Work Productivity and Activity Impairment (WPAI), and a study-specific questionnaire on quality of care and disease awareness. Telephone-based IDIs were conducted by medical interviewers following a semi-structured interview guide. Results: A total of 93 patients participated in the Web survey, and 33 participated in the IDIs. In the survey, the vast majority (77%; 72/93) had uncontrolled asthma (ACT<20). Mean total SGRQ score was 47.4 (59.7 symptom, 53.7 activity, 39.9 impact scores). Nearly 60% were treated in primary care. The IDIs revealed a long path to diagnosis, substantial and constant need for adaptations because of disease limitations, high burden on family members, social restrictions, and sick leaves and income losses. Patient awareness about guidelines, treatment goals, and available therapies was poor, and a low level of satisfaction by primary health care was seen. Conclusions: The vast majority of this severe asthma population had uncontrolled asthma and poor access to lung expert physicians. Impaired HRQOL despite patients’ adaptations was indicated. These findings highlight the need for structured patient education and greater access to units with disease-specific knowledge

Adherence and quality of life in adults and children during 3-years of SLIT treatment with Grazax-a real life study

Respiratory allergic disease represents a global health problem, 30% of the population suffers from allergic rhinoconjunctivitis and 20% suffer from asthma. Allergy immunotherapy induce immunological tolerance and thereby modify the response to allergens and sublingual immunotherapy (SLIT) offers the possibility of home administration of allergen therapy, but adherence is more uncertain. The aim of the study was to investigate the adherence with GRAZAX in adults and children ≥ 5 years during three consecutive years of treatment. This was a non-interventional, prospective, observational, multi-center, open-label study to investigate adherence, quality of life, safety and tolerability of GRAZAX in adult and pediatric patients in a real-life setting. During the 3-years study period estimation of adherence was done regularly. Quality of life as well as symptom score was also assessed. In total, 399 patients (236 adults and 163 children) were included in the study. At baseline, 100% suffered from moderate-severe eyes and nose symptoms, and 31% had asthma in the grass pollen season. Overall, 55% completed a 3-years treatment period, whereas 37% stopped before end of study and 8% were lost to follow up. After 3 years, the adherence rate decreased from 98.2% (first month), 93.7% (first year), 93.2% (second year) and 88.9% (third year) and adverse events were the main reason for pre-term termination. The study suggests a good adherence to treatment in a real life setting among the patients finalizing 3-years SLIT therapy. The treatment was effective both on symptoms and HRQL

Quality of life, school performance, treatment adherence and gender differences in asthma.

The aims of this thesis were to estimate the effectiveness of a computerized asthma education program designed to suit young people (I), to analyze whether quality of life changed over a five year period and whether young adults with asthma had impaired quality of life compared with a control group of the same age (II), to explore the association between current asthma, current rhinitis, current eczema and final grade for adolescents in comprehensive school (III), and to compare men and women with asthma with special emphasis on reported adherence, anxiety, and quality of sleep (IV). A hundred adolescents (17-18 years) from an asthma outpatient clinic for young adults were randomly assigned to either active education (intervention group) or normal care (control group). The intervention group completed an interactive computer program of 30 minutes’ duration providing information about asthma, mechanisms, trigger factors, allergies, and medication use, which was followed by a discussion with a specialized asthma nurse (I). A follow-up study was conducted among the cohort of young adults with asthma (n=64) and 248 general population controls, using a respiratory questionnaire and quality of life questionnaires (II). In the autumn of 2000, 10 837 schoolchildren aged 15 in Västra Götalandsregionen were investigated with a respiratory questionnaire (III). The second European Community Respiratory Health Survey (ECRHS II) was a follow-up study, performed between 1999 and 2002, among the participants in the second stage of ECRHS I. From among the ECRHS II participants living in the Nordic countries, 470 individual with current asthma were investigated with a structured clinical interview, including questions on the presence of respiratory symptoms and therapy. They were also asked to fill in the selfreported Hospital Anxiety Depression scale and the Basic Nordic Sleep Questionnaire (IV). Limited asthma education had no effect on asthma symptoms, asthma knowledge, or quality of life parameters among young adults with asthma. The prevalence of respiratory symptoms decreased in both the intervention group, and in the control group, and quality of life and knowledge about asthma increased in both groups. However, the educational program did appear to be associated with a significant improvement in FEV1. Young women with asthma seemed to have lower quality of life compared to young men with asthma, in spite of no difference in age of onset or severity of the disease. Adolescents with nasal symptoms severe enough to affect daily activity were at risk for low grades. Women with asthma had a more positive attitude towards their medication, had a higher reported adherence and used inhaled corticosteroids more often than men with asthma. At the same time women had more problems with anxiety and insomnia than men. Computerized education program did not show an effect on asthma symptoms, asthma knowledge or quality of life in specialist care. Young women with asthma seemed to have lower quality of life compared with young men with asthma. Nasal symptoms severe enough to affect daily activity were associated with low grades. Women with asthma had a more positive attitude towards their medication, have a higher reported adherence, and use inhaled corticosteroids more often than men. At the same time women report more often anxiety and insomnia than men

ALMA, a new tool for the management of asthma patients in clinical practice: development, validation and initial clinical findings.

BACKGROUND: Several instruments have been developed for measuring asthma control, but there is still a need to provide a structure for primary care asthma reviews. AIMS: The Active Life with Asthma (ALMA) tool was developed with the aim of structuring patient visits and assessing asthma treatment in primary care. The ability of ALMA to map out the care of asthma patients was evaluated and validated. METHODS: ALMA was developed with patient and clinical expert input. Questions were generated in focus groups and the resulting tool was subsequently validated by factor analysis in 1779 patients (1116 females) of mean age 51 years (range 18-89) in primary care. RESULTS: The ALMA tool includes 19 questions, 14 of which belong to a subset assessing asthma control. In this subset, factor analysis revealed three domains (factors): physical, psychological, and environmental triggers. Correlation with the Asthma Control Questionnaire was 0.72 and the Cronbach's alpha was 0.88. The test-retest reliability was 0.93. Of the 1779 patients tested with ALMA in primary care, 62% reported chest tightness, 30% nightly awakenings and 45% asthma breakthrough despite medication. CONCLUSIONS: The ALMA tool is useful as a follow-up instrument in clinical practice to structure patient visits and assess asthma treatment in primary care. The breadth of the questions and the pragmatic use in clinical practice also make it useful as an outcome measure

Quality of life in adolescents with asthma, during the transition period from child to adult.

Aim: The present investigation was designed to evaluate the health-related quality of life (HRQOL) of adolescents with asthma between the age of 16 and 21, when they are transferred from paediatric to adult care. Methods: In this prospective study, 156 teenagers (69 females) with asthma were screened employing spirometry, a histamine challenge, skin prick test for allergy and filled out the 'Living with Asthma Questionnaire' both at the time of entry into the study and after 2 and 5 years of follow-up. An exercise test and questions concerning regular performed exercise were carried out at baseline and 5 years later. Results: At all three time-points, the HRQOL of the men was generally better than that of the women. At the same time, the HRQOL of both genders was significantly better, both in terms of the overall scores (P < 0.001) as well as the scores for most of the individual domains, in connection with the 5-year follow-up. The young women who exercised regularly at the time of their entry exhibited better HRQOL at this time than those who did not (P < 0.001), whereas regular exercise had no impact on the HRQOL of the young men. The women with severe asthma demonstrated a poorer HRQOL than those suffering from mild-to-moderate asthma. Conclusion: The HRQOL of adolescents with asthma improves with age. The pronounced positive correlation between regular exercise and HRQOL in female adolescents with asthma revealed here deserves special attention in the care of young women and deserves further exploration

ALMA, a new tool for the management of asthma patients in clinical practice: development, validation and initial clinical findings.

BACKGROUND: Several instruments have been developed for measuring asthma control, but there is still a need to provide a structure for primary care asthma reviews. AIMS: The Active Life with Asthma (ALMA) tool was developed with the aim of structuring patient visits and assessing asthma treatment in primary care. The ability of ALMA to map out the care of asthma patients was evaluated and validated. METHODS: ALMA was developed with patient and clinical expert input. Questions were generated in focus groups and the resulting tool was subsequently validated by factor analysis in 1779 patients (1116 females) of mean age 51 years (range 18-89) in primary care. RESULTS: The ALMA tool includes 19 questions, 14 of which belong to a subset assessing asthma control. In this subset, factor analysis revealed three domains (factors): physical, psychological, and environmental triggers. Correlation with the Asthma Control Questionnaire was 0.72 and the Cronbach's alpha was 0.88. The test-retest reliability was 0.93. Of the 1779 patients tested with ALMA in primary care, 62% reported chest tightness, 30% nightly awakenings and 45% asthma breakthrough despite medication. CONCLUSIONS: The ALMA tool is useful as a follow-up instrument in clinical practice to structure patient visits and assess asthma treatment in primary care. The breadth of the questions and the pragmatic use in clinical practice also make it useful as an outcome measure

Swedish Translation and Validation of the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ).

Aim: The aim of the study was to translate and validate the PADQLQ (Pediatric allergic disease quality of life questionnaire), a disease specific quality of life questionnaire for the assessment of quality of life in children with pollen allergy. Methods: The PADQLQ was translated into Swedish according to guidelines. Children 7-18 years with grass pollen allergy were included. Quality of life was assessed in parallel with ordinary symptom scales (VAS) before, during and after the pollen season. Results: 98 children were included. 89 (91%) completed the study. The Results for PADQLQ showed good cross-sectional and longitudinal validity. The retrospective estimation after the season showed good consensus with the assessment during pollen season. Conclusion: Quality of life in children assessed with the PADQLQ (Pediatric allergic disease quality of life questionnaire), is a reliable strategy for evaluating the burden of disease in children with pollen allergy and for the evaluation of treatment