Comparison among three brands of budesonide in the treatment of allergic rhinitis: An open label, randomized clinical trial

Mathias, Lucas Bissacott; Trindade, Luiz Felipe Guilhermino; de Moraes, Luana Soares; Scussiatto, Henrique Ochoa; Garcia, Ellen Cristine Duarte; Fornazieri, Marco Aurélio

doi:10.1016/j.bjorl.2022.10.015

Brazilian Journal of Otorhinolaryngology (English Edition)

ISSN: 1808-8694

The Brazilian Journal of Otorhinolaryngology aims to provide timely information for physicians and scientists focused on otorhinolaryngology and head and neck disorders, including contemporary, ethical, clinically relevant information in:

- General otolaryngology;
- Head and neck surgery;
- Respiratory sleep disorders;
- Allergy/rhinology;
- Otology/neurotology;
- Laryngology/broncho-esophagology;
- Pediatric otolaryngology;
- Cranio-facial surgery;
- Skull base surgery;
- Head and neck oncology;
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MEDLINE/PubMed, Scopus, Web of Science/SCIE, DOAJ, Lilacs, SciELO, Qualis A3

Methods: An open label, randomized clinical trial was conducted, involving patients with a confirmed diagnosis of AR. Fifty-seven individuals were randomized into three groups. Each group underwent a 30-day treatment cycle with one of the three brands of topical nasal budesonide currently available in Brazil: Budecort Acqua. (brand-name), Busonid. (brand-name) and Noex. (generic). Each patient was submitted to olfactory function tests (University of Pennsylvania Smell Identification Test, UPSIT), nasal obstruction questionnaire (Nose Obstruction Symptom Rating Scale, NOSE), Peak Nasal Inspiratory Flow (PNIF) and the Rhinitis Control Assessment Test (RCAT) before and after treatment. The results were analyzed using Analysis of Variance ANOVA (complemented by Tukey's test) and Kruskal–Wallis, for comparison purposes among the three groups.

Results: Nineteen patients received Budecort Acqua, 19 Busonid and 19 Noex. Of the 57 randomized patients, 50 returned for data collection after 30 days of treatment. The number of dropouts was not statistically significant among the groups (p=0.13). All tests UPSIT, PNIF, NOSE and RCAT, significantly improved after 30 days of intervention in the three groups studied (p<0.01). None of the tests showed a statistically significant difference when compared among the groups, both pre and post-treatment values, in both ITT and PP data analyses, UPSIT (p=0.24 and p=0.26), PNIF (p=0.83 and p=0.79), NOSE (p=0.74 and p=0.58) and RCAT (p=0.23 and p=0.14). No serious adverse effects were reported in any of the three groups analyzed by the present study.

Conclusions: This study showed that the generic form of nasal budesonide and two corresponding brand drugs have similar efficacy in the treatment of AR. Further trials are required to compare the efficacy and safety of generic and brand-name drugs on a long-term basis.

Keywords: Allergic rhinitis; Corticosteroid; Treatment.

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