Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400828
• Other study ID #: YCD159
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2011
• Last updated: July 8, 2014
• Start date: June 2011
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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..

Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Bilastine
20 mg (encapsulated) tablets QD/14 days
• Desloratadine
5 mg (encapsulated) tablets QD/14 days
• Placebo
(encapsulated) Tablets QD/14 days

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University college of Medicine, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days	No
Secondary	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.	14 days	No
Secondary	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).	14days	No
Secondary	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	14 days	No
Secondary	•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	14 days	No
Secondary	VAS of discomfort	Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.	14 days	Yes
Secondary	CGI	Investigator's overall clinical impression (CGI)	14 days	No
Secondary	•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)	Quality of Life change versus baseline.	14 days	No
Secondary	responde's rate	Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).	14 days	No
Secondary	safety assessment	comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.	14 days	Yes