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Completed

NCT Number: NCT02513290

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilastine

Drug

Other names: Alektos

Loratadine

Drug

Other names: Claritin, Histadin, Loranil, Loritil, Loralerg

Primary outcomes

  1. Quality of life in patients with allergic rhinitis

    Time frame: 10 days

    Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)

Sponsors and collaborators

Lead sponsor

Universidade do Sul de Santa Catarina

Other Gov

Registry information

Official study title

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

Acronym: QolRhinitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2015
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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