A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

April 4, 2012 updated by: Faes Farma, S.A.

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of 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

Intervention / Treatment

Detailed Description

Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 68 years (Child, Adult, Older Adult)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
(encapsulated) Tablets QD/14 days
Experimental: Bilastine
Drug: Bilastine
20 mg (encapsulated) tablets QD/14 days
Active Comparator: Desloratadine
Drug: Desloratadine
5 mg (encapsulated) tablets QD/14 days
Other Names:
  • Aerius

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
Change in TSS. Instantaneous score
Time Frame: 14 days
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).
14 days
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.
14 days
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
14 days
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.
14 days
CGI
Time Frame: 14 days
Investigator's overall clinical impression (CGI)
14 days
Allergic rhinitis (AR) quality of life (QoL) questionnaire
Time Frame: 14 days
Quality of Life change versus baseline.
14 days
Onset of action
Time Frame: 2 days
Symptoms assessment in the first 48 hours since the beginning of the treatment
2 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Investigators

  • Principal Investigator: Piotr Kuna, Prof. Dr., Barlicki University Hospital, Medical University of Lodz (Poland)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILA 1003/RAE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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