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

Study Overview
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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.

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.

Official Title
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Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Bilastine
* Drug: Loratadine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilastine group<br>Bilastine 20 mg administered once a day for ten days. | Drug: Bilastine<br> <br> * Other names: Alektos;|
| Experimental: Loratadine group<br>Loratadine 10 mg administered once a day for ten days. | Drug: Loratadine<br> <br> * Other names: Loralerg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patients with allergic rhinitis | Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm) | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, allergic rhinitis, bilastine, loratadine, clinical trial