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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
20 mg (encapsulated) tablets QD/14 days
5 mg (encapsulated) tablets QD/14 days
(encapsulated) Tablets QD/14 days
Yonsei University college of Medicine, Gangnam Severance Hospital
Seoul, South Korea
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
Time frame: 14 days
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.
Time frame: 14 days
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).
Time frame: 14days
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
Time frame: 14 days
•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
Time frame: 14 days
VAS of discomfort
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
Time frame: 14 days
CGI
Investigator's overall clinical impression (CGI)
Time frame: 14 days
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•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)
Quality of Life change versus baseline.
Time frame: 14 days
responde's rate
Patients were analysed based on their total symptoms score decrease from baseline (\<25%, 25%-50%, 50%-75%, \>75%).
Time frame: 14 days
safety assessment
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