A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
|ClinicalTrials.gov Identifier: NCT01108783|
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : April 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Bilastine Drug: Desloratadine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||February 2004|
20 mg (encapsulated) tablets QD/14 days
|Active Comparator: Desloratadine||
5 mg (encapsulated) tablets QD/14 days
Other Name: Aerius
|Placebo Comparator: 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: 14 days ]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 [ Time Frame: 14 days ]Quality of Life change versus baseline.
- Onset of action [ Time Frame: 2 days ]Symptoms assessment in the first 48 hours since the beginning of the treatment
- 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): NCT01108783
|Principal Investigator:||Piotr Kuna, Prof. Dr.||Barlicki University Hospital, Medical University of Lodz (Poland)|