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A Prospective Randomized Non-blinded Study of Safety and Efficacy of Bilastine Up-dosing (40 mg) Versus Combination of Bilastine (20 mg) With Levocetrizine (5mg) in the Treatment of Chronic Spontaneous Urticaria

ClinicalTrials.gov · COMPLETED, 2026

60 participants

Abstract

This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life.

Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits.

The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.

Conditions: Chronic Spontaneous Urticaria (CSU).

Primary outcome: change in urticaria severity score (UAS7).

Enrollment: 60 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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