A study comparing how well levocetirizine, fexofenadine, and bilastine work, how safe they are, and how much they cost for treating allergy symptoms

Comparison of efficacy, safety, and cost-effectiveness of levocetirizine, fexofenadine, and bilastine in treatment of allergic rhinitis: A randomized, open-label, parallel-group study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082777

Enrollment

123

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: J308- Other allergic rhinitis

Interventions

Intervention1: Bilastine: Bilastine 20mg once a day for 4 weeks Control Intervention1: Levocetirizine: Levocetirizine 5mg once a day for 4 weeks Control Intervention2: Fexofenadine: Fexofenadine 120mg

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients aged above 18 years 2 Patient clinically diagnosed by ENT specialist with allergic rhinitis with symptoms of nasal congestion, rhinorrhoea, nasal itching, and sneezing occurring more than 4 days per week for at least 4 consecutive weeks.

Exclusion criteria

Exclusion criteria: 1 Patients with nasal polyps 2 Patients with significant hematopoietic, hepatic, renal, cardiovascular, neurologic, psychiatric, or autoimmune diseases 3 Pregnant or lactating women 4 History of failure to improve symptoms with antihistaminic drug treatment in the past 5 Patients with hypertension, urinary retention, or increased intraocular pressure 6 History of allergies to study medication or tolerance to antihistamines 7 Patients who received treatments; steroids and other disease-modifying drugs for the last 1 month and topical nasal drugs for the last 2 weeks

Design outcomes

Primary

Measure	Time frame
1.To assess and compare the efficacy of levocetirizine, fexofenadine, and bilastine in the treatment of allergic rhinitis. 2.To assess and compare the safety of levocetirizine, fexofenadine, and bilastine in the treatment of allergic rhinitis. Timepoint: 0, 2, 4, and 6 weeks	—

Secondary

Measure	Time frame
1. To assess and compare the cost-effectiveness of levocetirizine, fexofenadine, and bilastine in the treatment of allergic rhinitis.Timepoint: 0, 2, 4, and 6 weeks	—

Countries

India

Contacts

Public ContactDr Rutul Sanghani

All India Institute of Medical Sciences Rajkot

drrimashah@gmail.com9825741010

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026