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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bilastine
Loratadine
Sponsored by
Universidade do Sul de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring quality of life, allergic rhinitis, bilastine, loratadine, clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Bilastine group

    Loratadine group

    Arm Description

    Bilastine 20 mg administered once a day for ten days.

    Loratadine 10 mg administered once a day for ten days.

    Outcomes

    Primary Outcome Measures

    Quality of life in patients with allergic rhinitis
    Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2015
    Last Updated
    May 3, 2018
    Sponsor
    Universidade do Sul de Santa Catarina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02513290
    Brief Title
    Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine
    Acronym
    QolRhinitis
    Official Title
    Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade do Sul de Santa Catarina

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis
    Keywords
    quality of life, allergic rhinitis, bilastine, loratadine, clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilastine group
    Arm Type
    Experimental
    Arm Description
    Bilastine 20 mg administered once a day for ten days.
    Arm Title
    Loratadine group
    Arm Type
    Experimental
    Arm Description
    Loratadine 10 mg administered once a day for ten days.
    Intervention Type
    Drug
    Intervention Name(s)
    Bilastine
    Other Intervention Name(s)
    Alektos
    Intervention Type
    Drug
    Intervention Name(s)
    Loratadine
    Other Intervention Name(s)
    Claritin, Histadin, Loranil, Loritil, Loralerg
    Primary Outcome Measure Information:
    Title
    Quality of life in patients with allergic rhinitis
    Description
    Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jane da Silva, PhD
    Organizational Affiliation
    Universidade do Sul de Santa Catarina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10452758
    Citation
    Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):364-9. doi: 10.1016/s0091-6749(99)70380-5.
    Results Reference
    background
    PubMed Identifier
    22686617
    Citation
    Carter NJ. Bilastine: in allergic rhinitis and urticaria. Drugs. 2012 Jun 18;72(9):1257-69. doi: 10.2165/11209310-000000000-00000.
    Results Reference
    background
    PubMed Identifier
    11674923
    Citation
    Nascimento Silva M, Naspitz C, Sole D. Evaluation of quality of life in children and teenagers with allergic rhinitis: adaptation and validation of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Allergol Immunopathol (Madr). 2001 Jul-Aug;29(4):111-8. doi: 10.1016/s0301-0546(01)79042-8.
    Results Reference
    background
    PubMed Identifier
    19132976
    Citation
    Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.
    Results Reference
    background
    PubMed Identifier
    10848909
    Citation
    Van Cauwenberge P, Juniper EF. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.x.
    Results Reference
    background

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

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