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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
720
20 mg (encapsulated) tablets QD/14 days
5 mg (encapsulated) tablets QD/14 days
(encapsulated) Tablets QD/14 days
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: 14 days
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
Quality of Life change versus baseline.
Time frame: 14 days
Onset of action
Symptoms assessment in the first 48 hours since the beginning of the treatment
Time frame: 2 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