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

NCT07365683 | Completed

• 1 other identifier: IERC/DER/2024/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria (CSU)

Keywords

up-dosing +combination

Outcome Measures

Primary Outcomes (1)

• change in urticaria severity score (UAS7)

  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.

  baseline to 6 weeks

Study Arms (2)

Group A (tab bilastine 40mg )

ACTIVE COMPARATOR

patients received oral tab bilastine 20 mg twice daily for 6 weeks

Drug: tab bilastine 20 mg

Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg )

ACTIVE COMPARATOR

patients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks

Drug: tab bilastine 20 mg + tab levocetrizine 5 mg

Interventions

tab bilastine 20 mg DRUG

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

Group A (tab bilastine 40mg )

tab bilastine 20 mg + tab levocetrizine 5 mg DRUG

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

Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derma Techno Pakistan: lead

Study Sites (1)

combined military hospital ,Okara

Okāra, Punjab Province, 56300, Pakistan

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

bilastine; levocetirizine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: August 18, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 17, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

PA (1)