&lt;p&gt;MP-AzeFlu Improves the Quality-of-Life of Patients with Allergic Rhinitis&lt;/p&gt;

Weissenbruch, Ranny van; Klimek, Ludger; Gálffy, Gabriella; Emmeluth, Melanie; Koltun, Arkady; Kopietz, Ferdinand; Nguyễn, Duc Tung; Kuhl, Hans Christian; Pohl, Wolfgang; Scadding, Glenis; Price, David; Mullol, Joaquim

doi:10.2147/jaa.s277734

Cited by 9 publications

(3 citation statements)

References 29 publications

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“…The improvements in all RQLQ domains exceeded the minimum clinically significant difference of - 0.50 in all treatment groups. In a recent multicenter, prospective, non-interventional, real-life study, MP-AzeFlu improved patient-reported QoL regardless of the AR type [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis

et al. 2023

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Introduction The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR). Methods We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients. Results MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: − 1.96; 95% CI: − 2.53, − 1.39; p < 0.0001), or the FLU group (LS mean difference: − 0.98; 95% CI: − 1.55, − 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups. Conclusions MP-AzeFlu, when administered as one spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR. Trial Registration Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 . Supplementary Information The online version contains supplementary material available at 10.1007/s41030-023-00238-8.

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Section: Discussionmentioning

confidence: 99%

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis

et al. 2023

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“…The improvements in all RQLQ domains exceeded the minimum clinically signi cant difference of -0.50 in all treatment groups. In a recent multicenter, prospective, non-interventional, real-life study, MP-AzeFlu improved patient-reported QoL regardless of the AR type 21 .…”

Section: Quality Of Lifementioning

confidence: 93%

A clinical study to assess the efficacy and safety of MP-AzeFlu (Azelastine Hydrochloride and Fluticasone Propionate) nasal spray in comparison to commercially available nasal sprays in Chinese volunteers with allergic rhinitis

Zhou

Cheng

Pan

et al. 2023

Preprint

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Objective: The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine and fluticasone sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR). Methods: This was a multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-hour reflective total nasal symptom score (rTNSS) (Morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. 300 patients per treatment group were randomized which led to a total sample size estimation of 900 patients. Results: MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: -1.96; 95% CI: −2.53, −1.39; p < 0.0001), or the FLU group (LS mean difference: -0.98; 95% CI: −1.55, −0.41; p = 0.0007). The results of Adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups. Conclusion: MP-AzeFlu, when administered as 1 spray per nostril twice daily for 14 days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR. Trial registration: Clinicaltrials.gov; NCT03599791, Registered June 29,2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791

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“…Данные показали, что использование MP-AzeFlu уменьшило выраженность симптомов АР, улучшило качество жизни пациента (повлияв на сон и повседневную активность). Авторы рекомедуют препарат в качестве терапии 1-й линии для пациентов с АР [26].…”

Section: применение топических кортикостероидовunclassified

Intranasal corticosteroid use in patients with allergic rhinitis

Старостина

Toldanov

2021

Consilium Medicum

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Allergic rhinitis (AR) is one of the most common diseases in the world, which is based on IgE-mediated inflammation that develops after exposure to various allergens. About 40% of people suffer from the same or other allergic diseases, every third inhabitant of the Earth has symptoms of AR and every tenth has bronchial asthma. According to the ARIA classification, ARs are divided: by the nature of the flow, by the severity of the flow and by the stage of the flow; for symptoms, the proposed therapy, consisting of sequential steps. Groups of drugs include: systemic or topical blockers of histamine H1 receptors, intranasal and systemic corticosteroids, mast cell stabilizers (intranasal cromones), M-antagonists, antagonists of leukotriene receptors. Medicines do not give a lasting effect after their cancellation, therefore, with persistent AR, treatment should be prolonged; methods of application more often oral or intranasal. The advantages of the pharmacological antiallergic effect of InHCS are the simultaneous inhibition of both the early and late phases of the allergic response and the inhibition of all AR symptoms. The advantage of InHCS over oral administration is the minimal risk of developing systemic side effects against the background of the creation of adequate concentrations of the substance in the nasal mucosa, which allows to control the symptoms of AR. Based on data from a number of studies, the advantages of intrasal corticosteroids for AR, in particular fluticasone propionate, are used.

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<p>MP-AzeFlu Improves the Quality-of-Life of Patients with Allergic Rhinitis</p>

Cited by 9 publications

References 29 publications

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis

A clinical study to assess the efficacy and safety of MP-AzeFlu (Azelastine Hydrochloride and Fluticasone Propionate) nasal spray in comparison to commercially available nasal sprays in Chinese volunteers with allergic rhinitis

Intranasal corticosteroid use in patients with allergic rhinitis

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