Evidence map›Paper›PMID 34535609›Full record

Trial reportInternational archives of allergy and immunology

Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.

Alexander V Karaulov, Natalia I Ilina, Natalia Shartanova, Aleksandr Maslakov, Luiz Lucio

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International archives of allergy and immunology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03317015 (A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 33% 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.

NCT03317015 phase3completednot on this map

A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days

TypeinterventionalSponsorSanofiRan2016 to 2017Enrolled260ConditionsRhinitis AllergicArmstriamcinolone XRG5029, fluticasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Alexander V KaraulovDepartment of Clinical Immunology and Allergology of I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
Natalia I IlinaNational Research Centre, Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation.
Natalia ShartanovaMedical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.
Aleksandr MaslakovMedical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.
Luiz LucioMedical Department, Sanofi Consumer Healthcare, São Paulo, Brazil.
Federal Medical-Biological Agency · RUSanofi (Brazil) · BRSechenov University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAllergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks.

methodsNASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population.

resultsOf 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses.

conclusionsTAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

Indexed as

Anti-Inflammatory AgentsDisease ManagementHumansImmunosuppressive AgentsKaplan-Meier EstimatePrognosisQuality of LifeRhinitis, Allergic, PerennialRussiaTreatment OutcomeTriamcinolone AcetonideAnti-Inflammatory AgentsImmunosuppressive AgentsTriamcinolone AcetonideAllergic rhinitisFluticasone propionatePerennial allergic rhinitisReflective total nasal symptom scoreTriamcinolone acetonide

Identifiers

PMID34535609
PMCPMC8984997
OpenAlexW3199295687

What OpenQuestion holds

Textmetadata
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.