Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Summary

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

Timeline

Start

2024-11-11

Primary completion

2025-05-11

Completion

2025-06-11

Publications

• Background RICKHAM PP. HUMAN EXPERIMENTATION. CODE OF ETHICS OF THE WORLD MEDICAL ASSOCIATION. DECLARATION OF HELSINKI. Br Med J. 1964 Jul 18;2(5402):177. doi: 10.1136/bmj.2.5402.177. No abstract available.
• Background Shukla AK, Jhaj R, Misra S, Ahmed SN, Nanda M, Chaudhary D. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions. J Family Med Prim Care. 2021 Sep;10(9):3303-3308. doi: 10.4103/jfmpc.jfmpc_831_21. Epub 2021 Sep 30.
• Background Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
• Background Comite Nacional de Endocrinologia. [Considerations for safe glucocorticoid therapy]. Arch Argent Pediatr. 2018 Jun 1;116(3):s71-s76. doi: 10.5546/aap.2018.s71. Spanish.
• Background Horak F, Stubner UP, Zieglmayer R, Harris AG. Effect of desloratadine versus placebo on nasal airflow and subjective measures of nasal obstruction in subjects with grass pollen-induced allergic rhinitis in an allergen-exposure unit. J Allergy Clin Immunol. 2002 Jun;109(6):956-61. doi: 10.1067/mai.2002.124657.
• Background Simons FE, Prenner BM, Finn A Jr; Desloratadine Study Group. Efficacy and safety of desloratadine in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2003 Mar;111(3):617-22. doi: 10.1067/mai.2003.168.
• Background Mendoza de Morales T, Sanchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.
• Background Wandalsen GF, Miranda C, Ensina LF, Sano F, Amazonas RB, Silva JMD, Sole D. Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial. Braz J Otorhinolaryngol. 2017 Nov-Dec;83(6):633-639. doi: 10.1016/j.bjorl.2016.08.009. Epub 2016 Sep 13.
• Background Murdoch D, Goa KL, Keam SJ. Desloratadine: an update of its efficacy in the management of allergic disorders. Drugs. 2003;63(19):2051-77. doi: 10.2165/00003495-200363190-00010.
• Background Bachert C. A review of the efficacy of desloratadine, fexofenadine, and levocetirizine in the treatment of nasal congestion in patients with allergic rhinitis. Clin Ther. 2009 May;31(5):921-44. doi: 10.1016/j.clinthera.2009.05.017.
• Background Snyman JR, Potter PC, Groenewald M, Levin J; Claricort Study Group. Effect of betamethasone-loratadine combination therapy on severe exacerbations of allergic rhinitis : a randomised, controlled trial. Clin Drug Investig. 2004;24(5):265-74. doi: 10.2165/00044011-200424050-00003.
• Background Bernstein DI, Schwartz G, Bernstein JA. Allergic Rhinitis: Mechanisms and Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):261-78. doi: 10.1016/j.iac.2015.12.004. Epub 2016 Mar 10.
• Background May JR, Dolen WK. Management of Allergic Rhinitis: A Review for the Community Pharmacist. Clin Ther. 2017 Dec;39(12):2410-2419. doi: 10.1016/j.clinthera.2017.10.006. Epub 2017 Oct 25.
• Background Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.
• Background Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011 Dec 17;378(9809):2112-22. doi: 10.1016/S0140-6736(11)60130-X. Epub 2011 Jul 23.
• Background Meltzer EO, Rosario NA, Van Bever H, Lucio L. Fexofenadine: review of safety, efficacy and unmet needs in children with allergic rhinitis. Allergy Asthma Clin Immunol. 2021 Nov 2;17(1):113. doi: 10.1186/s13223-021-00614-6.

Drugs

Indications