Burden of allergic rhinitis and impact of MP-AzeFlu from the patient perspective: pan European patient survey (original) (raw)
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Rhinology journal
Background: Allergic Rhinitis and its Impact on Asthma (ARIA) and the European Union (EU) recommend a shift to guide allergic rhinitis (AR) treatment decisions from symptom severity to disease control, using a simple visual analogue scale (VAS). Using this VAS we assessed, in a real-life study in Romania, the effectiveness of MP-AzeFlu nasal spray. Methodology: In this multi-centre, prospective, non-interventional study, 253 patients (≥ 12 years old) with moderate-to-severe AR were prescribed MP-AzeFlu and assessed their symptoms on a VAS (0 (not at all bothersome) to 100 mm (very bothersome)) on Days 0, 1, 3, 7 and ~14. The proportion of patients who achieved a defined VAS score cutoff for well-controlled (38 mm) AR were also calculated. Patients' perception of disease control was assessed on Day 3. Results: MP-AzeFlu use was associated with a mean (standard deviation) VAS score reduction from 78.4 (15.1) mm at baseline to 14.7 (15.1) mm on the last day. Effectiveness was consistent irrespective of disease severity, phenotype or patient age. 83.4% of patients achieved the ≤ 38 mm 'well-controlled' VAS score cutoff by last day and 95.2% considered their symptoms to be well-or partly controlled at Day 3. Conclusions: MP-AzeFlu provided rapid, effective and sustained AR symptom control in a real-life setting in Romania, irrespective of severity, phenotype or patient age, aligning with ARIA and EU recommendations and supporting MP-AzeFlu's position as the drug of choice for the treatment of moderate-to-severe AR.
MP-AzeFlu Improves the Quality-of-Life of Patients with Allergic Rhinitis
Journal of Asthma and Allergy, 2020
Purpose: Patients with poorly controlled allergic rhinitis (AR) experience nasal symptoms, sleep disturbances, activity impairment, and decreased quality-of-life (QoL). MP-AzeFlu is safe and effective for moderate-to-severe seasonal and perennial AR, but its impact on QoL requires investigation in the real-world, especially among phenotypes of immunoglobulin (Ig)E-mediated AR. This subanalysis of an observational study evaluated response to MP-AzeFlu via assessment of sleep quality and trouble with daily activities. Patients and Methods: This multicenter, prospective, non-interventional, real-life study included a convenience sample of patients with a history of moderate-to-severe AR presenting with acute AR symptoms (visual analog scale [VAS] ≥50 mm). Over approximately 14 days of treatment with MP-AzeFlu (137 µg azelastine HCL and 50 µg fluticasone propionate administered via single 0.137-mL spray in each nostril twice daily), changes in sleep quality and trouble with daily work, school, social, and outdoor activities were evaluated using a VAS for the entire study population and for four subgroups based on IgE response phenotype. VAS scores ranged from "not at all troubled" (0 mm) to "extremely troubled" (100 mm). Results: Following MP-AzeFlu treatment, mean VAS scores for sleep quality impairment and work or school impairment decreased from 55.2 mm at baseline to 22.1 mm and 57.6 mm at baseline to 23.0 mm, respectively, after ~14 days. Similar results were observed for mean VAS scores for impairment of social activity (55.1 mm to 22.4 mm) and impairment of outdoor activity (64.4 mm to 25.0 mm). For all VAS scores, results were similar across populations, regardless of phenotype of IgE-mediated disease, comorbidity, age, and sex. Conclusion: MP-AzeFlu relieves symptoms and improves patient-reported QoL, illustrated by better sleep quality and less impairment of work, school, social, and outdoor activities after 14 days. The QoL benefits of MP-AzeFlu were consistent regardless of the phenotype of IgE-mediated disease.
Clinical and Molecular Allergy, 2020
Background Asthma affects up to nearly 40% of patients with allergic rhinitis (AR). Poor control of AR symptoms is associated with poor asthma control. The goal of this study was to evaluate the effect of AR treatment with MP-AzeFlu on symptoms of AR as well as symptoms of asthma. Methods This prospective study used a visual analog scale (VAS) to assess symptoms of AR and asthma before and after treatment with MP-AzeFlu (Dymista®; azelastine hydrochloride plus fluticasone propionate; 1 spray in each nostril twice daily for 2 weeks). Participants suffered from moderate-to-severe AR according to Allergic Rhinitis and its Impact on Asthma criteria, with acute AR symptoms (AR-VAS scores ≥ 50 mm) on inclusion day. In addition to symptom assessment, patients recorded the impact of AR symptoms on quality-of-life measures before, during, and at the conclusion of the treatment period (approximately 14 days). Patients self-reported change in frequency of their usage of asthma reliever medicat...
Allergy & rhinology (Providence, R.I.), 2017
Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control. To evaluate the effectiveness of MP-AzeFlu (Dymista®) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ∼14 days. On day 3, the patients assessed their level of disease control as well controlle...
World Allergy Organization Journal, 2020
Background: MP-AzeFlu (Dymistaâ; spray of azelastine/fluticasone propionate) is the most effective allergic rhinitis (AR) treatment available. Its effect on asthma outcomes in patients with AR and asthma is unknown. Methods: This pre-post historical cohort study, using the Optimum Patient Care Research Database, included patients aged !12 years, from UK general practice with active asthma (defined as a recorded diagnosis, with !1 prescription for reliever or controller inhaler) in the year before or at the initiation date. The primary study outcome was change in number of acute respiratory events (i.e. exacerbation or antibiotic course for a respiratory event) between baseline and outcome years. The effect size of MP-AzeFlu was quantified as the difference in % of patients that improved and worsened. Results: Of the 1,188 patients with AR and asthma included, many had a record of irreversible obstruction (67%), and uncontrolled asthma (70.4%), despite high mean daily doses of reliever/ controller therapy and acute oral corticosteroid use, in the year pre-MP-AzeFlu initiation. MP-AzeFlu initiation was associated with fewer acute respiratory events (effect size (e) ¼ 5.8%, p ¼ 0.0129) and a reduction in daily use of short-acting b 2-agonists, with fewer patients requiring >2 SABA puffs/week (e ¼ 7.7% p < 0.0001). More patients had well-controlled asthma 1-year post-MP-AzeFlu initiation (e ¼ 4.1%; p ¼ 0.0037), despite a reduction in inhaled corticosteroids (e ¼ 4.8%; p ¼ 0.0078). Conclusions: This study provides the first direct evidence of the beneficial effect of MP-AzeFlu on asthma outcomes in co-morbid patients in primary care in the United Kingdom.
International Archives of Allergy and Immunology, 2020
Introduction: Phenotyping allergic rhinitis (AR) by immunoglobulin E (IgE) sensitivity and comorbidities may help characterize AR and provide a framework for treatment decisions. Methods: This prospective, noninterventional study evaluated the effectiveness of MP-AzeFlu (azelastine hydrochloride plus fluticasone propionate intranasal spray formulation) across AR phenotypes. Patients with moderate-to-severe seasonal or perennial AR for whom MP-AzeFlu was prescribed were enrolled. AR subpopulations (ARPs) were assigned based on the classification of IgE response and comorbidities. AR symptoms over the previous 24 h were documented using an AR visual analog scale (AR-VAS), with ratings from “not at all bothersome” (0 mm) to “extremely bothersome” (100 mm), at the inclusion visit and on days 1, 3, 7, and the last day of the study (approximately day 14). AR quality-of-life measures were recorded using a VAS. Results: A total of 1,103 patients with AR were included. Mean baseline AR-VAS ...
Allergy, Asthma & Clinical Immunology, 2015
Background: Symptoms of allergic rhinitis (AR) have a detrimental effect on quality of life. The AR-Patient Benefit Index (AR-PBI), a specific self-assessment tool has been developed to assess treatment-related benefit in two separate sections: the Patient Needs Questionnaire (PNQ) which explores the patient's expectations before treatment and the Patient Benefit Questionnaire (PBQ) which evaluates treatment benefit. For the PNQ, three dimensions summarize patients' expectations: symptoms, social life and emotional state, thus covering a larger field than symptomatic relief. The aim of the study was to validate the French language version of the AR-PBI and to assess the treatment-related expectations and benefits provided in patients with allergic rhinitis treated with H1-antihistamines in a real-life study. Methods: BENEFICA was a prospective, observational study involving patients with allergic rhinitis who were starting treatment with H1-antihistamines. The Patient Needs Questionnaire (PNQ) was administered before treatment (D0) and the Patient Benefit Questionnaire (PBQ) was collected after a 14-day course of H1-antihistamines (D15). Discomfort (visual analog scale), and quality of life (miniRQLQ) were measured on D0 and D15. Results: Three thousands and eighty-nine patients were enrolled in the study: mean age 39 ± 14 years, women 52%, 81% of patients with moderate to severe persistent rhinitis (Allergic Rhinitis and its Impact on Asthma, ARIA); 19% had (a) concomitant condition(s), 18% were asthmatic, and 12% had atopic dermatitis. Discomfort and quality of life improved between D0 and D15. AR-PBI was 2.7 ± 0.8, superior to 1 (threshold for clinically relevant benefit) for 97% of patients and greater in patients willing to continue the treatment. PBI was moderately correlated to change in miniRQLQ (r = −0.45, p < 0.0001) and change in discomfort (r = −0.38, p < 0.0001), suggesting a richer conceptual content than symptoms relief. Conclusions: The French version of the Allergic Rhinitis-Patient Benefit Index (AR-PBI) has been validated. It complements the discomfort and quality of life tools and assesses the needs and benefits in patients suffering from allergic rhinitis. This new tool may help physicians to better understand patients' expectations and to discuss treatment issues with their patients.
BMJ open, 2017
The aims of this study were (1) to characterise the type of patient prescribed MP-AzeFlu (Dymista, a novel formulation of azelastine hydrochloride, fluticasone propionate and excipients in a single spray) in real life in the UK and physicians' reasons for prescribing it and (2) to quantify the personal and societal burden of allergic rhinitis (AR) in the UK prior to MP-AzeFlu prescription. This multicentre, non-interventional study enrolled patients (n=193) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its licensed indications. Information was gathered on patient demographics, AR history and symptom severity, symptomatology and AR treatments in the previous calendar year (prior to MP-AzeFlu prescription). Physicians also recorded the number of previous AR visits, specific reasons for these visits and their reason for prescribing MP-AzeFlu. Most patients had seasonal AR either alone (10.4%) or in combination with ...
A new treatment satisfaction measure for asthmatics: a validation study
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2000
The Patient Satisfaction with Asthma Medication (PSAM) questionnaire was developed because no treatment satisfaction questionnaire could be identified that was comprehensive yet brief enough for use in clinical trials. Adult moderate asthmatics residing in Canada using an inhaled medication (either salmeterol, formoterol, or albuterol) self-administered the questionnaire, which also included the Asthma Quality of Life Questionnaire (AQLQ). A total of 53 asthmatics (70% female, 45% married, mean age: 47 years) completed the questionnaire. Using variable clustering, four PSAM scales were identified: Inhaler Properties, Comparison with Other Medications, Overall Perception of Medication, and Relief. Internal-consistency reliability provided evidence of reliability and lack of redundancy (Cronbach's Alpha: 0.82-0.88). Test-retest reliability was acceptable (ICC values at or near 0.70). As expected, interscale PSAM correlations were moderate to high; correlations between the PSAM and...