Olfaction in patients with allergic rhinitis: an indicator of successful MP‐AzeFlu therapy

Klimek, Ludger; Poletti, Sophia C.; Sperl, Annette; Spielhaupter, Magdalena; Bardenhewer, Cornel; Mullol, Joaquim; Hörmann, K.; Hummel, Thomas

doi:10.1002/alr.21877

Cited by 17 publications

(15 citation statements)

References 23 publications

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“…The trials used different study designs, methods, and sample sizes. Three trials did not find significant effects on olfaction [ 58 – 60 ]; 11 studies [ 42 – 44 , 61 – 68 ] that totaled 866 patients treated with INFP from 3 months to 5 years showed significant improvements in olfaction (see Table 1 for summary of the studies).…”

Section: Application Of the Bradford Hill Criteriamentioning

confidence: 99%

“…A prospective observational study in patients with mild, moderate, or severe perennial allergic rhinitis (PAR) treated with intranasal azelastine 548 mcg + INFP 200 mcg once daily reported significant beneficial effects on anosmia and nasal symptoms; 93–96% patients achieved complete recovery of normal sense of smell at 1 month of therapy with further complete recovery of olfaction achieved in 100% of patients at 3 months of therapy [ 68 ]. This was the first and only study to report full recovery of olfaction in all participants.…”

Section: Application Of the Bradford Hill Criteriamentioning

confidence: 99%

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Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

2018

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Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. While intranasal corticosteroids are associated with olfactory and gustatory dysfunction and are currently labeled for these adverse events, causality assessment has not been performed to date. Although there is no single widely accepted method to assess causality in pharmacovigilance, the Bradford Hill criteria offer a robust and comprehensive approach because nine distinct aspects of an observed potential drug–event association are assessed. In this literature-based narrative review, Hill’s criteria were applied to determine causal inference between INFP and olfactory and gustatory dysfunction.

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Section: Application Of the Bradford Hill Criteriamentioning

confidence: 99%

Section: Application Of the Bradford Hill Criteriamentioning

confidence: 99%

Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

2018

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“…Azelastine hydrochloride has been formulated with fluticasone propionate in a single intranasal spray (MP-AzeFlu; Dymista ® ) for the treatment of AR [ 11 ]. Compared with fluticasone propionate or azelastine hydrochloride alone, MP-AzeFlu resulted in significantly greater improvements in AR symptoms, including nasal congestion, one of the most bothersome and prevalent symptoms of AR, [ 12 – 14 ] nasal cell inflammation [ 15 ], loss of smell [ 16 ], and nasal hyperreactivity [ 17 ]. Relative to individual dosing of both an INAH and INCS, MP-AzeFlu was also associated with lower pharmacy costs and total costs in a prior database analysis [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma

Price

Klimek

Gálffy³

et al. 2020

Clin Mol Allergy

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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 medication on the last day of treatment. Results: Of 1103 study participants, 267 (24.2%) had comorbid asthma. These participants reported using a mean of 5.1 puffs of asthma reliever medication in the week before treatment with MP-AzeFlu. A total of 81.8% of patients with comorbid asthma responded to AR therapy (AR-VAS < 50 mm on at least 1 study day). Among patients with AR and comorbid asthma, MP-AzeFlu was associated with improved VAS scores across all study parameters, including AR symptom severity, asthma symptom severity, sleep quality, daily work or school activities, daily social activities, and daily outdoor activities. Asthma symptom severity decreased from a mean of 48.9 mm to 24.1 mm on the VAS. Selfreported frequency of asthma reliever medication use was reduced for 57.6% of participants (n = 139/241). Conclusion: MP-AzeFlu used to relieve AR symptoms was associated with reduced asthma symptom VAS scores and frequency of asthma reliever medication usage. Changes in overall symptoms of AR and asthma were correlated.

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“…Azelastine hydrochloride has been formulated with fluticasone propionate in a single spray (MP-AzeFlu) for the treatment of AR. MP-AzeFlu is a safe, effective, and rapid-acting option for treating AR symptoms, including nasal congestion [9], loss of smell [10], and nasal hyperreactivity [11]. MP-AzeFlu has demonstrated a superior effect compared with other intranasal drugs in monotherapy at both the symptom and anti-inflammatory levels [12, 13].…”

Section: Introductionmentioning

confidence: 99%

Effect of Specific Immunoglobulin E Response and Comorbidities on Effectiveness of MP-AzeFlu in a Real-Life Study

Klimek

Price

Gálffy³

et al. 2020

Int Arch Allergy Immunol

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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-tosevere 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 both-ersome" (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 scores ranged from 70.3 to 75.1 mm (severe) across ARPs. In the overall population, 86.6% of patients responded to treatment (AR-VAS score <50 mm on ≥1 days). In the ARPs, response rates ranged from 79.3 to 89.6%. Mean reduction in AR-VAS scores ranged from 47.9 to 40.9 mm, a decrease from severe to mild across all ARPs. Quality-of-life VAS scores were similarly reduced in the total population and ARPs. Discussion/Conclusion: MP-AzeFlu treatment reduced VAS severity and quality-of-life scores from baseline in the total population and ARPs, supporting MP-AzeFlu as an effective treatment for all patients with moderate-to-severe AR, regardless of AR phenotype or comorbidities.

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Olfaction in patients with allergic rhinitis: an indicator of successful MP‐AzeFlu therapy

Cited by 17 publications

References 23 publications

Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma

Effect of Specific Immunoglobulin E Response and Comorbidities on Effectiveness of MP-AzeFlu in a Real-Life Study

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