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

May 3, 2018 updated by: Jane da Silva, Universidade do Sul de Santa Catarina

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilastine group
Bilastine 20 mg administered once a day for ten days.
Drug: Bilastine
Other Names:
  • Alektos
Experimental: Loratadine group
Loratadine 10 mg administered once a day for ten days.
Drug: Loratadine
Other Names:
  • Claritin
  • Histadin
  • Loranil
  • Loritil
  • Loralerg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Sul de Santa Catarina

Investigators

  • Principal Investigator: Jane da Silva, PhD, Universidade do Sul de Santa Catarina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTBixLo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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