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

NCT01400828 | Completed Phase 3

• 1 other identifier: YCD159
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in TSS. Reflective symptoms

  14 days

• Change in TSS. Instantaneous score

  14days

• Change in total nasal symptom score (TNSS)

  14 days

• •Change in total non-nasal symptom score (TNNSS)

  14 days

• VAS of discomfort

  14 days

Study Arms (3)

Bilastine

EXPERIMENTAL

Intervention: Drug: Bilastine

Drug: Bilastine

Desloratadine

ACTIVE COMPARATOR

Intervention: Drug: Desloratadine

Drug: Desloratadine

Placebo

PLACEBO COMPARATOR

Intervention: Drug: Placebo

Drug: Placebo

Interventions

Bilastine DRUG

20 mg (encapsulated) tablets QD/14 days

Bilastine

Desloratadine DRUG

5 mg (encapsulated) tablets QD/14 days

Also known as: Aerius

Desloratadine

Placebo DRUG

(encapsulated) Tablets QD/14 days

Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Yonsei University college of Medicine, Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

bilastine; desloratadine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

KR (1)