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Completed

NCT Number: NCT01400828

Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean 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.

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Key information

Conditions

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

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University college of Medicine, Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilastine

Drug

20 mg (encapsulated) tablets QD/14 days

desloratadine

Drug

5 mg (encapsulated) tablets QD/14 days

Other names: Aerius

Placebo

Drug

(encapsulated) Tablets QD/14 days

Primary outcomes

  1. AUC of TSS

    Time frame: 14 days

    The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment

Secondary outcomes

  1. Change in TSS. Reflective symptoms

    Time frame: 14 days

    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.

  2. Change in TSS. Instantaneous score

    Time frame: 14days

    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).

  3. Change in total nasal symptom score (TNSS)

    Time frame: 14 days

    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

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

    Time frame: 14 days

    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

  5. VAS of discomfort

    Time frame: 14 days

    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.

  6. CGI

    Time frame: 14 days

    Investigator's overall clinical impression (CGI)

  7. •Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)

    Time frame: 14 days

    Quality of Life change versus baseline.

  8. responde's rate

    Time frame: 14 days

    Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).

  9. safety assessment

    Time frame: 14 days

    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 22, 2011
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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