Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
|ClinicalTrials.gov Identifier: NCT01400828|
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : July 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Bilastine Drug: Desloratadine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||June 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||May 2014|
Intervention: Drug: Bilastine
20 mg (encapsulated) tablets QD/14 days
Active Comparator: Desloratadine
Intervention: Drug: Desloratadine
5 mg (encapsulated) tablets QD/14 days
Other Name: Aerius
Placebo Comparator: Placebo
Intervention: Drug: Placebo
(encapsulated) Tablets QD/14 days
- AUC of TSS [ Time Frame: 14 days ]The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment
- Change in TSS. Reflective symptoms [ Time Frame: 14 days ]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 [ Time Frame: 14days ]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) [ Time Frame: 14 days ]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) [ Time Frame: 14 days ]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 [ Time Frame: 14 days ]Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
- CGI [ Time Frame: 14 days ]Investigator's overall clinical impression (CGI)
- •Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ) [ Time Frame: 14 days ]Quality of Life change versus baseline.
- responde's rate [ Time Frame: 14 days ]Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).
- safety assessment [ Time Frame: 14 days ]comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400828
|Korea, Republic of|
|Yonsei University college of Medicine, Gangnam Severance Hospital|
|Seoul, Korea, Republic of|