Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and methods: Seventy patients with allergic rhinitis participated in a prospective, randomized, double-blind, parallel, active controlled, comparative 4 week trial. The patients between age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent allergic rhinitis were included. The study inclusion criteria required the subjects with Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indira Gandhi Medical College; Indira Gandhi Medical College, Shimla
• Treatments: Cetirizine; Fexofenadine; Levocetirizine; Montelukast; Terfenadine

Criteria

Inclusion Criteria:

• either gender having moderate-severe intermittent or mild persistent allergic rhinitis according to original Aria classification.

• subjects with Total Nasal Symptom Score (TNSS) of 5 or higher.

• not treated with antihistaminics in previous week.

• Patients willing to sign written informed consent

• free of any clinically significant disease

• having normal E.C.G

Exclusion Criteria:

• participation of children, pregnant female, nursing mothers,

• patients with asthma requiring chronic use of inhaled or systemic corticosteroids

• history of failure to improve symptoms with antihistaminic drug treatment in the past 4.history of allergies to study medication or tolerance to antihistamines, 5.use of study drug in the last 7 days. 6. subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease