Back to resultsInvestigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bilastine
Desloratadine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
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
Sites / Locations
- Yonsei University college of Medicine, Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bilastine
Desloratadine
Placebo
Arm Description
Intervention: Drug: Bilastine
Intervention: Drug: Desloratadine
Intervention: Drug: Placebo
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 (RQLQ)
Quality of Life change versus baseline.
responde's rate
Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).
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
1. Study Identification
Unique Protocol Identification Number
NCT01400828
Brief Title
Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
Official Title
Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilastine
Arm Type
Experimental
Arm Description
Intervention: Drug: Bilastine
Arm Title
Desloratadine
Arm Type
Active Comparator
Arm Description
Intervention: Drug: Desloratadine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Drug: Placebo
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
14days
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 (RQLQ)
Description
Quality of Life change versus baseline.
Time Frame
14 days
Title
responde's rate
Description
Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).
Time Frame
14 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
Facility Information:
Facility Name
Yonsei University college of Medicine, Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
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