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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.
Nasal symptom changes will be assessed daily over a 10-day intervention period using the Total Nasal Symptom Score (TNSS) for allergic rhinitis. Patients will complete the first questionnaire during the randomization visit, followed by daily entries each night before bedtime using a patient diary. The final assessment will be completed during the study's end-of-treatment visit.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Desloratadine 5 mg + Betamethasone 0.25 mg | Experimental | Administered orally, one tablet a day, for 10 days. |
|
| Group B: Desloratadine 5 mg | Active Comparator | Administered orally, one tablet a day, for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine / Betamethasone in fixed dose | Drug | 1 tablet, once a day of 5 mg / 0.25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the magnitude of change in the TNSS over the 10-day intervention period versus the baseline, by treatment group. | The Total Nasal Symptom Score (TNSS) is a clinical measure used to assess the severity of nasal symptoms in patients, particularly those suffering from allergic rhinitis. It assess the four cardinal symptoms of allergic rhinitis: sneezing, rhinorrhea (nasal mucus discharge), nasal pruritus (itching), and nasal obstruction (difficulty breathing). According to the evaluation the magnitude of the symptoms could be classified as: None, Mild, Moderate and Severe. The researcher will apply the TNSS score to each patient at each visit and follow up call, to assess improvement in symptoms. At the end of the clinical trial the magnitude of change will be measured and compared between treatment groups. | 10 days |
| will be measured and compared between treatment groups. | To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare quality of life, measured as the change in score on the modified Likert scale for this outcome, by treatment group, at days 5 and 10 of the intervention compared to baseline. | A Likert scale for quality of life is a rating scale used to measure opinions, attitudes, or behaviors. It consists of a statement or a question, followed by a series of six answer statements. Quality of life should be assessed by the principal investigator or designated physician at each visit. |
| Measure | Description | Time Frame |
|---|---|---|
| To report the percentage of therapeutic adherence at day 10 of the intervention in each treatment group. | Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation. | 10 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge A Gonzalez, PhD | Contact | 5254883785 | 3761 | jogonzalez@silanes.com.mx |
| Yulia Romero-Antonio, B.S. | Contact | 5254883785 | 3777 | yromero@silanes.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Francisco MurguÃa MartÃn, MD | Unidad de Medicina Especializada SMA | Principal Investigator |
| TobÃas Avendaño Santiago, MD | Oaxaca Site Management Organization, S.C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Recruiting | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14150898 | 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. | |
| 34760748 | 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. |
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| Desloratadine | Drug | 1 tablet, once a day of 5 mg |
|
|
| 10 days |
| Describe disease severity and improvement using the CGI scale by treatment group, at days 5 and 10 of the intervention compared to baseline. | The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The evaluation range goes from 1 - 7: 1- Marked improvement, 2- improvement, 3- slightly improved, 4- no change, 5- slightly worsened, 6- worsened, and 7- markedly worsened. | 10 days |
| Describe the PGA of the treatment received at days 5 and 10 of the intervention, by treatment group. | Patient's Global Assessment (PGA) is often assessed by a single question with a 0-4 response. On Days 5 and 10 of the intervention, a PGA of response to treatment will be conducted, using a scoring scale from 0 to 4, with 4 representing the worst possible assessment. | 10 days |
| Erika N Durón López, MD |
| Centro de Investigación Médica de Aguascalientes |
| Principal Investigator |
| MarÃa D Escobar Zalapa, MD | CICMEX Centro de Investigación ClÃnica de México S de RL de CV | Principal Investigator |
| 20526405 | 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. |
| 35786822 | 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. |
| 12063524 | 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. |
| 12642846 | 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. |
| 23282980 | 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. |
| 27670203 | 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. |
| 12962522 | 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. |
| 19539095 | 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. |
| 17503888 | 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. |
| 27083101 | 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. |
| 29079387 | 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. |
| 27434218 | Background | Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780. |
| 21783242 | 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. |
| 34727966 | 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. |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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