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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Bilastine; Drug: Desloratadine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine, Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bilastine; Intervention: Drug: Bilastine	Drug: Bilastine; 20 mg (encapsulated) tablets QD/14 days
ACTIVE_COMPARATOR: Desloratadine; Intervention: Drug: Desloratadine	Drug: Desloratadine; 5 mg (encapsulated) tablets QD/14 days; Other Names: Aerius
PLACEBO_COMPARATOR: Placebo; Intervention: Drug: Placebo	Drug: Placebo; (encapsulated) Tablets QD/14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
CGI	Investigator's overall clinical impression (CGI)	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).	14days
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
•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
•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)	Quality of Life change versus baseline.	14 days
responde's rate	Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).	14 days
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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (ESTIMATE): July 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Desloratadine
• Other Study ID Numbers: YCD159