Improvements In Asthma-related Quality Of Life Research Articles

Bronchial Thermoplasty for Severe Asthma: From Past to Present and Future

Background: Approximately 3-10% of all asthmatics are refractory with severe disease, although they use optimal preventive treatment. This is reflected as a disproportionate increase in the cost of health care. Thus, bronchial thermoplasty has been developed as an add-on therapy for these refractory asthmatics. Objective: This review aims to give an update on bronchial thermoplasty in severe asthma regarding pathophysiological mechanisms of action, patient selection, procedural details, history, evidence- based effectiveness, safety and cost-effectiveness, place in management, and challenges in current clinical practice. Methods: A thorough search for the eligible and recent studies and reviews on bronchial thermoplasty and asthma has been conducted in PubMed. Results: In bronchial thermoplasty, radiofrequency energy delivered to bronchial airway walls leads to ablation of the airway smooth muscles that cause bronchoconstriction. Several large trials and a real-world study confirm its safety, and effectiveness, as shown by considerable reduction in asthma exacerbations, emergency department visits and hospitalizations as well as improvement in asthma-related quality of life, maintained up to 5 years. These improvements are more significant in more severe airway obstruction. Bronchial thermoplasty is more cost-effective if hospitalization and emergency department care cost high, but the procedure costs low. Properly performed patient identification, implementation and follow-up are critical for successful and safe outcomes with the procedure. Conclusion: A 10-year research and clinical experience has proved the long-term safety, and effectiveness of bronchial thermoplasty for improving asthma control and quality of life in severe asthma. Predictors of response (e.g. biomarkers, responder endotype/phenotype) remain to be studied further and better qualified.

The Impact of Bronchial Thermoplasty on Asthma-Related Quality of Life and Controller Medication Use

Background: Despite an improved understanding of the pathophysiology of asthma, severe asthma sufferers continue to experience a poor quality of life (QOL). Bronchial thermoplasty (BT) utilizes thermal energy to reduce airway smooth muscle. In industry-sponsored trials, BT improves QOL and reduces severe exacerbations; however, the impact of BT on asthma-related QOL and medication use in non-industry-sponsored trials is less clear. Objective: The aim of this study was to determine the impact of BT on asthma QOL measures (mini-AQLQ) and asthma controller medication use during the year following treatment with BT. Methods: We performed a prospective study of the impact of BT in 25 patients with severe persistent asthma. Our primary outcome was change in asthma-related QOL score (mini-AQLQ) 1 year after BT treatment. Our secondary outcome was change in asthma medication use 1 year after BT. Results: BT led to an improvement in mini-AQLQ score from a baseline of 3.6 ± 0.3 before therapy to 5.6 ± 0.3 1 year after the final BT procedure. Overall, 88% percent of patients showed a clinically significant improvement in mini-AQLQ at 1 year. Patients treated with BT showed a reduction in the use of montelukast and omalizumab 1 year after BT. Conclusion: In patients with severe persistent asthma and low asthma-related QOL scores, BT leads to an improvement in asthma-related QOL and a decrease in asthma medication use when measured 1 year after the final BT treatment.

Symptom Control and Improved Functioning: The Effect of Omalizumab on Asthma-Related Quality of Life (ARQL)

This investigation evaluated variability in asthma-related quality-of-life (ARQL) outcomes among patients randomized to omalizumab or placebo. Pooled data on the Asthma Quality of Life Questionnaire (AQLQ) from two trials were used (n = 948). Variability in ARQL outcomes was determined by categorizing AQLQ score changes according to minimal clinically important difference (MCID: 0.5 points) and large clinically important difference (LCID: 1.5 points) score changes. A greater proportion of patients achieved improvement in every domain of AQLQ scores during all periods with omalizumab compared with placebo. Omalizumab-treated patients showed greater clinically important improvement in ARQL compared with patients receiving placebo.

Efficacy, tolerability, and effect on asthma-related quality of life of formoterol bid via multidose dry powder inhaler and albuterol QID via metered dose inhaler in patients with persistent asthma: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study

Background: Inhaled beta 2-agonists are widely used in asthma treatment. The design limitations of pressurizedmetered dose inhalers (pMDIs) have prompted the development of dry powder inhalers (DPIs) for the delivery of asthma medications. Objective: The goal of this study was to evaluate the efficacy, tolerability, and effect on asthma-related quality of life (QOL) of a long-acting beta 2-adrenoreceptor agonist, formoterol, delivered via multidose DPI, compared with albuterol delivered via pMDI or placebo in adolescents and adults with persistent asthma. Methods: This multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-groupstudy was conducted in outpatient clinics at 18 US centers. Adolescents and adults with persistent asthma received formoterol 10 pg BID via multidose DPI, albuterol 180 μg QID via pMDI, or placebo for 12 weeks. The primary efficacy variable was the 12-hour AUC of forced expiratory volume in 1 second (FEV 1) after 12 weeks treatment. Secondary efficacy variables included asthma-related QOL, asthma symptom scores, rescue medication use, and other pulmonary function measures. Results: A total of 239 patients (147 females, 92 males; age range, 13–85 years) with persistent asthma were enrolled (formoterol, n = 80; albuterol, n = 79; placebo, n = 80). Formoterol delivered via the multidose DPI resulted in clinically relevant and statistically significant increases in 12-hour AUC of FEV 1 after 12 weeks of treatment compared with albuterol pMDI and placebo ( P < 0.019 and P < 0.001, respectively). Asthma-related QOL (total score) was significantly improved with formoterol treatment compared with placebo ( P < 0.015). Nocturnal asthma symptom scores significantly improved with formoterol compared with albuterol and placebo ( P < 0.001 and P < 0.003, respectively) and rescue medication use was significantly less with formoterol compared with albuterol and placebo ( P < 0.004 and P < 0.002, respectively). Treatment with formoterol was well tolerated. Conclusions: In this study of adolescents and adults with persistent asthma, 12 weeks of treatment with formoterol 10 μg BID delivered via a multidose DPI provided significantly greater 24-hour bronchodilation compared with albuterol and placebo and resulted in significant improvements in asthma-related QOL compared with placebo. Formoterol was well tolerated in these patients.

Improvements in Asthma Pharmacotherapy and Self-Management

In day-to-day practice, asthma treatment and self-management often fall short of the objectives defined by clinical practice guidelines. The objective of this study was to determine whether a population-based asthma disease management program, using broad-based educational interventions, can have a favorable impact on physician and patient adherence to guidelines-based care. A longitudinal, before-and-after design was used to evaluate program impacts on pharmacotherapy and health status. Patients with asthma (n = 35 450) were enrolled in the program from September 2000 through to June 2001. Patients were identified for the study based on a 12-month retrospective analysis of pharmacy claims. Patients were members of prescription benefit plans managed by Medco Health and were aged 5 years and older. Patients in the intervention group received asthma education materials during the 12-month period following enrollment. The materials emphasized guidelines-based principles of asthma pharmacotherapy, self-management, trigger avoidance and patient-physician partnership. Physicians received guidelines-based flow sheets to facilitate therapy tracking, and pharmacotherapy review. Asthma drug utilization was measured during the 12-month period prior to enrollment and the 12-month period following enrollment. Utilization data on controller and reliever medications were derived from a pharmacy claims database. Drug utilization changes for the intervention group were compared with those for matched controls. A health survey was conducted on a random sample of program participants at enrollment and at 12-month follow-up. The health survey included questions on asthma-related quality of life (QOL), medical utilization, productivity, and self-management skills. The percentage of patients who started controller therapy during the study period was significantly higher for the intervention group than the control group (20.7% versus 18.1%, p < 0.001). The controller prescription fill rate increased significantly in the intervention group compared with controls (p < 0.0001); the increase was primarily driven by increased refill rates for patients already using controllers. Reliever prescription fill rates decreased for both the intervention group and controls. Program participants reported significant improvements in asthma-related QOL (p < 0.05) and self-management skills. Self-reported medical utilization decreased for office visits (p < 0.05) and emergency room visits (p < 0.01). A population-based asthma disease management program can improve controller prescribing rates (new therapy starts), controller adherence rates (refill persistency), and self-management skills. These changes in physician and patient behavior help close the gaps between guidelines and practice in asthma therapy.

Omalizumab improves asthma-related quality of life in patients with severe allergic asthma

Background: We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled corticosteroid (ICS) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs. Objective: The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life (QOL). Methods: These analyses were part of a multicenter, 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of subcutaneous omalizu-mab (≥0.016 mg/kg of IgE [in international unit per milliliter] per 4 weeks) in 525 adults with severe allergic asthma. A 16-week steroid-stable phase was followed by a 12-week steroid-reduction phase and a 24-week double-blind extension phase. The effect of treatment on asthma-related QOL was evaluated by using the Asthma Quality of Life Questionnaire (AQLQ) administered at baseline and at weeks 16, 28, and 52. Results: The 2 treatment groups were comparable in terms of baseline AQLQ scores. At weeks 16, 28, and 52, omalizumab-treated patients demonstrated statistically significant improvements across all AQLQ domains, as well as in overall score. Moreover, a greater proportion of patients receiving omali-zumab achieved a clinically meaningful improvement in asthma-related QOL during each phase of the study. Greater than 50% of both patients and investigators rated treatment similarly with omalizumab as excellent or good compared with less than 40% of placebo recipients. Conclusion: In patients requiring moderate-to-high doses of ICSs for severe allergic asthma, the measurably improved disease control afforded by add-on omalizumab therapy is paralleled by clinically meaningful improvements in asthma-related QOL. (J Allergy Clin Immunol 2003;111:278-84.)