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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bilastine group

Bilastine 20 mg administered once a day for ten days.

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Loratadine group

Loratadine 10 mg administered once a day for ten days.

Group Type EXPERIMENTAL

Loratadine

Intervention Type DRUG

Interventions

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Bilastine

Intervention Type DRUG

Loratadine

Intervention Type DRUG

Other Intervention Names

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Alektos Claritin Histadin Loranil Loritil Loralerg

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No