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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
1 tablet, once a day of 5 mg / 0.25 mg
1 tablet, once a day of 5 mg
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
RECRUITINGComparison 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.
Time frame: 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.
Time frame: 10 days
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.
Time frame: 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.
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Time frame: 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.
Time frame: 10 days