Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil

Launched by EUROFARMA LABORATORIOS S.A. · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, levocetirizine and pseudoephedrine, to see if they work better together than levocetirizine alone for treating allergic rhinitis, which is a common condition that causes symptoms like a runny nose, sneezing, and nasal congestion when exposed to allergens. The goal is to find a safe and effective treatment to help relieve these symptoms, especially the blockage in the nose that many people experience. Patients aged 12 to 65 who have been diagnosed with allergic rhinitis for at least two years may be eligible to participate, provided they meet certain health criteria.

Participants in this trial will need to sign a consent form and will be closely monitored throughout the study. They will receive either the combination treatment or levocetirizine alone to compare how well each option helps with their symptoms. This research is important because it aims to provide new treatment options for people who struggle with allergic rhinitis and need more effective relief from their nasal symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients of both sexes who meet all of the following criteria will be enrolled in the study:
• • 1. 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.
• • 2. Age ≥ 12 years and ≤ 65 years and weight ≥ 40 kg.
• • 3. 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:
• • 1. 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.
• • 2. Presence of significant septal deviation, compatible with impaired nasal ventilatory function, at the discretion of the investigator.
• • 3. Presence of nasal polyposis on anterior rhinoscopy.