The impact of GINA suggested drugs for the treatment of asthma on Health‐Related Quality of Life: a GA<sup>2</sup>LEN review

Baiardini, Ilaria; Braido, Fulvio; Brandi, Silvia; Tarantini, Francesco; Бонини, С.; Bousquet, Philippe‐Jean; Zuberbier, Torsten; Demoly, Pascal; Canonica, Giorgio Walter

doi:10.1111/j.1398-9995.2008.01823.x

Cited by 41 publications

(27 citation statements)

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“…The AQLQ is a validated tool for assessing the impact of asthma and evaluating outcomes of various therapies (27). This study demonstrates a clear effect of BT on improving the asthma-specific quality of life over 1 year despite a larger-than-expected improvement in the sham group.…”

Section: Discussionmentioning

confidence: 71%

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Castro

Rubin

Laviolette

et al. 2010

Am J Respir Crit Care Med

624

289

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Rationale: Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle. Objectives: To evaluate the effectiveness and safety of BT versus a sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting b 2 -agonists. Methods: A total of 288 adult subjects (Intent-to-Treat [ITT]) randomized to BT or sham control underwent three bronchoscopy procedures. Primary outcome was the difference in Asthma Quality of Life Questionnaire (AQLQ) scores from baseline to average of 6, 9, and 12 months (integrated AQLQ). Adverse events and health care use were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary endpoint (96.4%). Measurements and Main Results:The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 6 1.10; sham, 1.16 6 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Seventy-nine percent of BT and 64% of sham subjects achieved changes in AQLQ of 0.5 or greater (PPS, 99.6%). Six percent more BT subjects were hospitalized in the treatment period (up to 6 wk after BT). In the posttreatment period (6-52 wk after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits, and days missed from work/ school compared with the sham group (PPS, 95.5, 99.9, and 99.3%, respectively).Conclusions: BT in subjects with severe asthma improves asthmaspecific quality of life with a reduction in severe exacerbations and healthcare use in the posttreatment period. Clinical trial registered with www.clinialtrials.gov (NCT00231114).Keywords: asthma; Alair Bronchial Thermoplasty System; bronchial thermoplasty; bronchoscopic procedure; Asthma Quality of Life Bronchial thermoplasty (BT) is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures, resulting in a prolonged reduction in airway smooth muscle (ASM) mass (1, 2). Increased mass and contractility of ASM augments asthma morbidity by causing greater bronchoconstriction and airflow obstruction (3). Decreasing the amount and/or contractility of ASM may provide a means to ameliorate the symptoms of asthma.Previous clinical trials of BT were nonrandomized (4) or randomized to include a standard of care control group (5, 6). In these initial studies, BT was associated with a decrease in the AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Bronchial thermoplasty is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures. What This Study Adds to the FieldThe current study reflects one of the largest shamcontrolled trials in pulmonary medicine to test a novel device to perform bronchial thermoplasty, a procedure for the treatment of ...

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Section: Discussionmentioning

confidence: 71%

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Castro

Rubin

Laviolette

et al. 2010

Am J Respir Crit Care Med

624

289

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“…The EQ-5D is a generic HRQoL questionnaire, and although not specific for asthma, it is considered valid for cross-sectional population studies of patients with this disease [2]. …”

Section: Introductionmentioning

confidence: 99%

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study

Barcala¹,

Fuente-Cid²,

Tafalla

et al. 2012

Multidiscip Respir Med

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BackgroundThe measurement of health-related quality of life (HRQoL) is increasingly recognized as an important endpoint, as a reflection of the effects of the disease from a patient perspective. Our aim was to evaluate the factors determining the HRQoL in patients with asthma, according to the EQ-5D questionnaire.MethodsPatients were included using multi-stage sampling, from Primary Care clinics from all the Autonomous Communities in Spain. The patients included were: over 18 years-old, with a confirmed diagnosis of asthma for at least one year, and had visited a Health Centre in the previous 2 years. The characteristics of the asthma disease, the adherence to treatment, the socio-demographic variables, the smoking habits, and the asthma control were collected using a questionnaire. The influence of the different variables included in the study on the EQ-5D was evaluated using multivariate logistic regression analysis.ResultsA total of 2,125 patients were finally included (57.7% females, mean age 48 years). The response rate was 95.4%. Some factors showed a considerable detrimental effect on the HRQoL of asthmatics. Advanced age, lower educational level and poor control of asthma are significantly associated with a worse quality of life in all the dimensions assessed by the EQ-5D scale. The baseline severity of the asthma, and having been admitted to hospital are related to a worse quality of life in 5 of the 6 dimensions analyzed.ConclusionIn our study, we could identify some factors related to quality of life in asthma patients. The most important were advanced age, lower education level, and poor control of the asthma.

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“…* (P = number of puffs corresponding to all FABA and combivent dispensed over last 3 months)# (quantity dispensed/3 months) [144]† Calculated once exercise monitoring questionnaire is completed 4 or more times (average is the mean value for the first three entries, × = the last steps entry)%Action Plan questions: do you understand what to do in your action plan? ; Are you able to describe the signs or symptoms you have when your asthma is getting worse?…”

Section: Designmentioning

confidence: 99%

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

Ahmed

Bartlett

Ernst

et al. 2011

Trials

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BackgroundAsthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life.MethodsThe trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010.DiscussionSelf-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change.Trial RegistrationCurrent Controlled Trials ISRCTN34326236.

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The impact of GINA suggested drugs for the treatment of asthma on Health‐Related Quality of Life: a GA²LEN review

Cited by 41 publications

References 53 publications

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

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The impact of GINA suggested drugs for the treatment of asthma on Health‐Related Quality of Life: a GA2LEN review

Cited by 41 publications

References 53 publications

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

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The impact of GINA suggested drugs for the treatment of asthma on Health‐Related Quality of Life: a GA²LEN review