Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT01400828
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
- The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
- Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..
- Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
- Patients were not allowed to take forbidden medications or not comply the study requirements.
- Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
- Pregnant or breast-feeding women were also excluded.
- Women of childbearing potential had a pregnancy test done
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Intervention: Drug: Placebo Bilastine Bilastine Intervention: Drug: Bilastine Desloratadine Desloratadine Intervention: Drug: Desloratadine
- Primary Outcome Measures
Name Time Method AUC of TSS 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
- Secondary Outcome Measures
Name Time Method Change in total nasal symptom score (TNSS) 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) 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
safety assessment 14 days comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.
responde's rate 14 days Patients were analysed based on their total symptoms score decrease from baseline (\<25%, 25%-50%, 50%-75%, \>75%).
Change in TSS. Reflective symptoms 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 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).
VAS of discomfort 14 days Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ) 14 days Quality of Life change versus baseline.
CGI 14 days Investigator's overall clinical impression (CGI)
Trial Locations
- Locations (1)
Yonsei University college of Medicine, Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of