Double-blind phase: The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis. Open-label Phase: The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter study followed by an open label extension. Duration of the double-blind period was 28 days and the duration of the open label period was 12 additional months. The primary efficacy variable of the double-blind period was the area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms. 650 patients were included in the study and 614 completed the double-blind phase. Out of the 614 patients who completed the double blind period, a total of 513 patients started the open label period with Bilastine 20 mg (83.6%)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
650
20 mg encapsulated tablets
10 mg encapsulated tablets
encapsulated tablets
Double-blind phase: AUC of TSS throughout the study
Area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms.
Time frame: 28 days
Open-label phase: Long-term safety
Evaluation of the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis. The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study), ECGs on M3, M6, M9 and M12 visits and routine laboratory analyses (haematology and biochemistry) performed at M3, M6, M9 and M12 visits.
Time frame: 12 months
AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.
Time frame: 28 days
Change in the TSS on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
Time frame: Day 14 and day 28
Change in Nasal Symptoms Score (NSS)
Change in Nasal Symptoms Score (NSS) on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Time frame: Day 14 and day 28
Change in Non Nasal Symptoms Score (NNSS)
Change in Non Nasal Symptoms Score (NNSS) on symptom scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Time frame: Day 14 and day 28
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Change in individual nasal and non nasal symptoms
Change in each of the NSS or NNSS on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
Time frame: Day 14 and day 28
AUC of NSS, NNSS and each individual nasal andn non nasal symptom
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on reflective symptoms
Time frame: 28 days
AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on instantaneous symptoms. Time to maximum relief of symptoms
Time frame: 28 days
Overall assessment of discomfort
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits
Time frame: Day 14 and day 28
Investigator's clinical global impression
Time frame: 28 days
Quality of Life change from baseline
Time frame: 28 days
Responders rate
Responders were classified based on their total symptom score decrease to baseline: \<25%, 25%-50%, 50%-75%, \>75% and were described by treatment group with their percentage and 95% confidence interval.
Time frame: 28 days
Time to maximum response
Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.
Time frame: 48 hours
Safety and tolerability
The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study, ECGs on D0 and D28 visits and routine laboratory analyses (haematology and biochemistry) performed at D0 and D28 visits.
Time frame: 28 days