Evidence map›Paper›PMID 37580498›Full record

ArticlePulmonary therapy2023

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.

Bing Zhou, Lei Cheng, Jing Pan, Huizhong Wang, Yongde Jin, Changqing Zhao, Peng Lin, Guolin Tan, Hongyan Fang, Hua Zhang and 5 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pulmonary therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03599791 (Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03599791 phase3completednot on this map

Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis

TypeinterventionalSponsorMEDA Pharma GmbH & Co. KGRan2018 to 2019Enrolled900ConditionsAllergic RhinitisArmsAzelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT, Fluticasone Propionate 0.05 MG/ACTUAT
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 2 countries.

Bing ZhouDepartment of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100051, China. entzhou@263.net.
Lei ChengDepartment of Otorhinolaryngology & Clinical Allergy Center, The First Affiliated Hospital, Nanjing Medical University, Nanjing, 210029, China.
Jing PanDepartment of Otolaryngology Head and Neck Surgery, Tianjing Renmin Hospital, Nankai University, Tianjing, China.
Huizhong WangDepartment of Otolaryngology Head and Neck Surgery, Zibo Central Hospital, Zibo, China.
Yongde JinDepartment of Otolaryngology Head and Neck Surgery, Yanbian University Hospital, Yanji, China.
Changqing ZhaoDepartments of Otolaryngology Head and Neck Surgery, Second Affiliated Hospital, Shanxi Medical University, Taiyuan, China.
Peng LinDepartment of Otolaryngology Head Neck Surgery, Tianjin First Central Hospital, Tianjin Medical University, Tianjin, China.
Guolin TanDepartment of Otolaryngology Head Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, China.
Hongyan FangDepartment of Otolaryngology Head Neck Surgery, Chongqing General Hospital, Chongqing, China.
Hua ZhangDepartment of Otolaryngology Head Neck Surgery, The first affiliated Hospital of Xinjiang Medical University, Wulumuqi, China.
Huifang ZhouDepartment of Otolaryngology Head Neck Surgery, Tianjin Medical University General Hospital, Tianjin, China.
Yaowu DongDepartment of Otolaryngology Head Neck Surgery, Tonghua Central Hospital, Tonghua, China.
Hans Christian KuhlBiometrics, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany.
Rajesh Kumar RamalingamMylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, India.
Duc Tung NguyenGlobal Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad Homburg, Germany.
Beijing Tongren Hospital · CNCentral Hospital of Zibo · CNFirst People's Hospital of Chongqing · CNMylan (India) · INNanjing Medical University · CNNankai University · CNSecond Hospital of Shanxi Medical University · CNThird Xiangya Hospital · CNTianjin First Center Hospital · CNTianjin Medical University General Hospital · CNTonghua Normal University · CNXinjiang Medical University · CNYanbian University Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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).

methodsWe 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.

resultsMP-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.

conclusionsMP-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 registrationClinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .

Indexed as

Allergic rhinitisAzelastineFixed-dose combinationFluticasoneSeasonal allergic rhinitis

Identifiers

PMID37580498
PMCPMC10447793
OpenAlexW4385812397

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.