Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil (ALERZIN)
Allergic Rhinitis
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria: Patients of both sexes who meet all of the following criteria will be enrolled in the study: Signature of the Informed Consent Form (ICF) for those over 18 years of age and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the legal representative before any study procedure. Age ≥ 12 years and ≤ 65 years and weight ≥ 40 kg. Clinical diagnosis of intermittent or persistent allergic rhinitis according to the definition of the Allergic Rhinitis and its Impact on Asthma2 (ARIA) group (Attachment 1) for at least two (02) years. Exclusion Criteria: Patients who meet at least one of the following criteria will be excluded from the study: Concomitant presence of other types of rhinitis (such as infectious rhinitis, drug rhinitis, rhinitis in the elderly, hormonal rhinitis, non-allergic occupational rhinitis) when known. Presence of significant septal deviation, compatible with impaired nasal ventilatory function, at the discretion of the investigator. Presence of nasal polyposis on anterior rhinoscopy.
Sites / Locations
- Eurofarma Laboratorios S.A
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1
Group 2
Investigational group: FDC levocetirizine 5mg / pseudoephedrine 240mg from Eurofarma Laboratórios S.A.
Comparator group: Levocetirizine 5mg (Zina® - comparator drug)