The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Classification of severity of nasal blockage by Visual Analog Scale (VAS)
Time frame: at the end of weeks 1, 2, 3, 4
Incidence of laboratory alterations
Time frame: day 14, 28 and 35
Incidence of premature discontinuations of the study due to adverse events
Time frame: up to 4 weeks
Incidence and severity of all adverse events
Time frame: up to 5 weeks
Daily evaluation of the nasal blockage by the patient
Time frame: daily up to 4 weeks
Classification of the severity of the symptoms by the investigator
Time frame: at the end of weeks 1, 2, 3, 4
Changes in nasal physical examination
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by investigator
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Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4