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

Yuhan

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Desloratadine; Drug: Placebo; Drug: Bilastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01400828

YCD159

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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239 participants in 3 patient groups, including a placebo group

Bilastine

Experimental group

Description:

Intervention: Drug: Bilastine

Treatment:

Drug: Bilastine

Desloratadine

Active Comparator group

Description:

Intervention: Drug: Desloratadine

Treatment:

Drug: Desloratadine

Placebo

Placebo Comparator group

Description:

Intervention: Drug: Placebo

Treatment:

Drug: Placebo