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.
Willing to participate in the study and able to provide written informed consent.
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.
Patients for whom the investigational drug is medically contraindicated.
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.
Parallel
Desloratadine / Betamethasone in fixed dose
Drug1 tablet, once a day of 5 mg / 0.25 mg
Desloratadine
Drug1 tablet, once a day of 5 mg
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.
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.
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.
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.
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.
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.
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