Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07365683

Enrollment

Registered

2026-01-26

Start date

2025-08-18

Completion date

2026-01-17

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria (CSU)

Keywords

up-dosing +combination

Brief summary

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.

Interventions

DRUGtab bilastine 20 mg

tab bilastine 20 mg given orally twice a day for 6 weeks

DRUGtab bilastine 20 mg + tab levocetrizine 5 mg

tab levocitrizine 5 mg given orally at night with combination of tab bilastine 20 mg in the morning for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients with diagnosis of CSU as per operational definitions. * Patients already taking Bilastine 20 mg and still getting new lesions. * UAS7 score \>3 * Age range of 18-70 years * Both male and female patients

Exclusion criteria

* • women Patients who have already received treatment of CSU other than Bilastine. * Patients taking oral or topical corticosteroids * Pregnant or lactating * Patients with hereditary angioedema, atopic dermatitis, systemic immune disorders, collagen vascular diseases, immunocompromised status, Chronic liver or kidney failures

Design outcomes

Primary

Measure	Time frame	Description
change in urticaria severity score (UAS7)	baseline to 6 weeks	change in urticaria severity score (UAS7) from baseline to 6 weeks UAS7 is a validated composite score assessing daily wheal number and pruritis severity over 7 consecutive days ,with total scores ranging from 0 to 42. Higher scores indicate more severe urticaria activity and a reduction in score reflects clinical improvement.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026