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


Journal

International archives of allergy and immunology
ISSN: 1423-0097
Titre abrégé: Int Arch Allergy Immunol
Pays: Switzerland
ID NLM: 9211652

Informations de publication

Date de publication:
Historique:
received: 07 04 2021
accepted: 28 05 2021
pubmed: 19 9 2021
medline: 1 3 2022
entrez: 18 9 2021
Statut: ppublish

Résumé

Allergic 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. NASANIF (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. Of 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. TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

Identifiants

pubmed: 34535609
pii: 000518754
doi: 10.1159/000518754
pmc: PMC8984997
doi:

Substances chimiques

Anti-Inflammatory Agents 0
Immunosuppressive Agents 0
Triamcinolone Acetonide F446C597KA

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

168-175

Informations de copyright

© 2021 The Author(s) Published by S. Karger AG, Basel.

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Auteurs

Alexander V Karaulov (AV)

Department of Clinical Immunology and Allergology of I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.

Natalia I Ilina (NI)

National Research Centre, Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation.

Natalia Shartanova (N)

Medical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.

Aleksandr Maslakov (A)

Medical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.

Luiz Lucio (L)

Medical Department, Sanofi Consumer Healthcare, São Paulo, Brazil.

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Classifications MeSH