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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01400828
First received: July 20, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Bilastine
Drug: Desloratadine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • AUC of TSS [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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:
  • Change in TSS. Reflective symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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: 14days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Investigator's overall clinical impression (CGI)

  • •Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Quality of Life change versus baseline.

  • responde's rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).

  • safety assessment [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.


Estimated Enrollment: 240
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aerius
Placebo Comparator: Placebo
Intervention: Drug: Placebo
Drug: Placebo
(encapsulated) Tablets QD/14 days

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400828

Locations
Korea, Republic of
Yonsei University college of Medicine, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01400828     History of Changes
Other Study ID Numbers: YCD159
Study First Received: July 20, 2011
Last Updated: July 15, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on April 22, 2014