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A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bilastine
Desloratadine
Placebo
Sponsored by
Faes Farma, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis, Sneezing, Nasal itching, Nasal Congestion, Rhinorrhea, Ocular itching, Ocular redness, Tearing

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
  • Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

  • Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
  • Patients were not allowed to take forbidden medications or not comply the study requirements.
  • Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
  • Pregnant or breast-feeding women were also excluded.
  • Women of childbearing potential had a pregnancy test done

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Bilastine

    Desloratadine

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    AUC of TSS
    The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.

    Secondary Outcome Measures

    Change in TSS. Reflective symptoms
    Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.
    Change in TSS. Instantaneous score
    Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score).
    Change in total nasal symptom score (TNSS)
    Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment.
    Change in total non-nasal symptom score (TNNSS)
    Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment
    VAS of discomfort
    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
    CGI
    Investigator's overall clinical impression (CGI)
    Allergic rhinitis (AR) quality of life (QoL) questionnaire
    Quality of Life change versus baseline.
    Onset of action
    Symptoms assessment in the first 48 hours since the beginning of the treatment
    Safety assessment
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.

    Full Information

    First Posted
    April 21, 2010
    Last Updated
    April 4, 2012
    Sponsor
    Faes Farma, S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01108783
    Brief Title
    A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
    Official Title
    Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    August 2003 (Actual)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Faes Farma, S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
    Detailed Description
    Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seasonal Allergic Rhinitis
    Keywords
    Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis, Sneezing, Nasal itching, Nasal Congestion, Rhinorrhea, Ocular itching, Ocular redness, Tearing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    720 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilastine
    Arm Type
    Experimental
    Arm Title
    Desloratadine
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Bilastine
    Intervention Description
    20 mg (encapsulated) tablets QD/14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Desloratadine
    Other Intervention Name(s)
    Aerius
    Intervention Description
    5 mg (encapsulated) tablets QD/14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    (encapsulated) Tablets QD/14 days
    Primary Outcome Measure Information:
    Title
    AUC of TSS
    Description
    The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Change in TSS. Reflective symptoms
    Description
    Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.
    Time Frame
    14 days
    Title
    Change in TSS. Instantaneous score
    Description
    Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score).
    Time Frame
    14 days
    Title
    Change in total nasal symptom score (TNSS)
    Description
    Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment.
    Time Frame
    14 days
    Title
    Change in total non-nasal symptom score (TNNSS)
    Description
    Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment
    Time Frame
    14 days
    Title
    VAS of discomfort
    Description
    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
    Time Frame
    14 days
    Title
    CGI
    Description
    Investigator's overall clinical impression (CGI)
    Time Frame
    14 days
    Title
    Allergic rhinitis (AR) quality of life (QoL) questionnaire
    Description
    Quality of Life change versus baseline.
    Time Frame
    14 days
    Title
    Onset of action
    Description
    Symptoms assessment in the first 48 hours since the beginning of the treatment
    Time Frame
    2 days
    Title
    Safety assessment
    Description
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering. Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination.. Exclusion Criteria: Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed. Patients were not allowed to take forbidden medications or not comply the study requirements. Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded. Pregnant or breast-feeding women were also excluded. Women of childbearing potential had a pregnancy test done
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piotr Kuna, Prof. Dr.
    Organizational Affiliation
    Barlicki University Hospital, Medical University of Lodz (Poland)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    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
    result

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    A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

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