Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Bilastine; Drug: Loratadine

• Registration Number: NCT02513290
• Lead Sponsor: Universidade do Sul de Santa Catarina

Brief Summary

The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.

Detailed Description

This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
• patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)

Exclusion Criteria

• pregnancy or breast-feeding;
• non-allergic rhinitis (vasomotor, infectious or drug-induced);
• known hypersensitivity to antihistamines;
• clinical disorders that might affect the assessment;
• nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
• therapy with immunotherapy;
• use of antihistamines or disodium cromoglycate within the past four weeks;
• use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
• use of topical antihistamines or nasal decongestants within the last 48 hours;
• use of deposit steroid within the last month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilastine group	Bilastine	Bilastine 20 mg administered once a day for ten days.
Loratadine group	Loratadine	Loratadine 10 mg administered once a day for ten days.

Primary Outcome Measures

Name	Time	Method
Quality of life in patients with allergic rhinitis	10 days	Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)