Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
NCT ID: NCT06916884
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2024-11-11
2025-06-11
Brief Summary
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Detailed Description
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Quality of life, global clinical impression, and patient global assessment will be evaluated during in-person visits conducted at baseline, Day 5, and Day 10.
The incidence of adverse events throughout the study will be analyzed by treatment group and reported as frequencies and percentages. Events will be classified according to frequency, seriousness, severity, and their relationship to the investigational product.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Desloratadine 5 mg + Betamethasone 0.25 mg
Administered orally, one tablet a day, for 10 days.
Desloratadine / Betamethasone in fixed dose
1 tablet, once a day of 5 mg / 0.25 mg
Group B: Desloratadine 5 mg
Administered orally, one tablet a day, for 10 days.
Desloratadine
1 tablet, once a day of 5 mg
Interventions
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Desloratadine / Betamethasone in fixed dose
1 tablet, once a day of 5 mg / 0.25 mg
Desloratadine
1 tablet, once a day of 5 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis (based on medical history and physical examination) of active allergic rhinitis at study entry.
* Patients presenting with moderate to severe nasal symptoms, with a Total Nasal Symptom Score (TNSS) ≥5.
* In the case of women of childbearing potential who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal), as determined by the investigator.
* In the opinion of the Principal Investigator or treating physician, the patient is indicated for treatment with the investigational product and may derive clinical benefit from it.
Exclusion Criteria
* Known allergy or hypersensitivity to the active ingredient, study medications, related products, or excipients.
* History of nasal trauma (surgical or accidental) within the past week.
* Positive pregnancy test, pregnant or breastfeeding women, or women planning to become pregnant during the course of the study.
* Acute or chronic lower or upper respiratory tract infections, such as the common cold, influenza, pneumonia, bronchitis, or chronic sinusitis.
* History of non-allergic rhinitis, such as chronic non-allergic rhinitis, drug-induced rhinitis, atrophic rhinitis, hormonal rhinitis, or unilateral rhinitis, as reported in the medical history or patient interview.
* History of nasal polyposis, primary ciliary dyskinesia syndrome, and/or non-allergic rhinitis with eosinophilia syndrome (NARES).
* Current smokers, or history of alcohol and/or drug abuse in the past year according to DSM-V criteria.
* History of seizure disorders, status epilepticus, or generalized tonic-clonic seizures.
* History of chronic hepatic failure classified as Child-Pugh C, as reported in the medical history or patient interview.
* History of chronic renal failure (glomerular filtration rate \< 30 mL/min/1.73 m²), as reported in the medical history or patient interview.
* Any condition, in the investigator's opinion, that affects prognosis or precludes outpatient management, which must be evaluated by the principal investigator to determine the subject's eligibility.
* History of severe, progressive, unstable, or advanced disease of any kind that could interfere with efficacy and safety evaluations or pose a risk to the patient.
* Oncology patients (except those with basal cell skin cancer) or patients with serious illnesses who, in the investigator's opinion, have a poor prognosis or life expectancy of less than one year, including those with mental health disorders.
* Active participation in another clinical trial involving an investigational treatment or participation in any clinical study within the previous two weeks.
* Patients whose participation in the study may be influenced (e.g., employees of the research center or sponsor, incarcerated individuals, etc.).
* Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, dyspnea) and/or contact within the past 14 days with a suspected or confirmed COVID-19 case and/or a positive COVID-19 test.
18 Years
60 Years
ALL
No
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Francisco Murguía Martín, MD
Role: PRINCIPAL_INVESTIGATOR
Unidad de Medicina Especializada SMA
Tobías Avendaño Santiago, MD
Role: PRINCIPAL_INVESTIGATOR
Oaxaca Site Management Organization, S.C
Erika N Durón López, MD
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación Médica de Aguascalientes
María D Escobar Zalapa, MD
Role: PRINCIPAL_INVESTIGATOR
CICMEX Centro de Investigación Clínica de México S de RL de CV
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.
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.
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.
Other Identifiers
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SIL-30810-III-23(1)
Identifier Type: -
Identifier Source: org_study_id
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