Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension

September 25, 2012 updated by: Faes Farma, S.A.

A Phase III, Comparative Study for the Efficacy and Safety of Bilastine 20 mg Versus Cetirizine 10 mg and Placebo in the Treatment of Perennial Allergic Rhinitis During 4 Weeks, Followed by a Long-term Safety Extension With Bilastine 20 mg

Double-blind phase: The objective of the study was to evaluate the efficacy and safety of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic rhinitis.

Open-label Phase: The objective of this extension was to evaluate the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter study followed by an open label extension. Duration of the double-blind period was 28 days and the duration of the open label period was 12 additional months.

The primary efficacy variable of the double-blind period was the area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms. 650 patients were included in the study and 614 completed the double-blind phase. Out of the 614 patients who completed the double blind period, a total of 513 patients started the open label period with Bilastine 20 mg (83.6%)

Study Type

Interventional

Enrollment (Actual)

650

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

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of either sex aged from 12 to 70 years of age
  • Patients with a documented clinical history of PAR for at least 2 years prior to the study inclusion
  • Positive skin prick test for at least one of the following perennial allergens (house-dust mites, Dermatophagoides pteronyssinus or D. farinae, animal danders, dogs or cats, molds, etc.)
  • Patients had to have a sum in the previous 6 assessments of the reflective nasal symptoms score equal to or greater than 30 (≥30 over 72). Additionally, at the time of randomization patients had to have positive symptomatology in instantaneous nasal symptoms equal or greater than 5 (≥5 over 12).
  • Women of childbearing potential had to have a negative pregnancy test and had to use an effective contraceptive method.
  • Provision of written informed consent to participate and willing to attend the required visits scheduled in the protocol
  • The criteria to continue with the open label period included previous participation in the double blind period, eligibility for a long-term symptomatic treatment according to the investigator assessment and patient willingness to follow the treatment for one year.

Exclusion Criteria:

  • Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
  • Negative skin prick test (as defined in point 6.1.1.).
  • Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months.
  • Any other nasal illness that can interfere with the aim of the study.
  • Patients who have acute or chronic sinusitis as judged by the investigator.
  • Patients who are also diagnosed with SAR (seasonal allergic rhinitis), and the inclusion and follow-up during the double-blind phase in this study is concurrent with the pollen season.
  • Immunotherapy (6 months): In case of patients under immunotherapy the treatment had to have started more than 6 months prior to the start of the study, the doses could not be modified during the study, and any doses could not be administered 24 hours before any study visit..
  • Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
  • Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmia, recent acute myocardial infarction or neoplastic diseases

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
Experimental: Bilastine
20 mg encapsulated tablets
Drug: Bilastine
20 mg encapsulated tablets
Active Comparator: Cetirizine
10 mg encapsulated tablets
Drug: Cetirizine
10 mg encapsulated tablets
Other Names:
  • Zyrtec
Placebo Comparator: Placebo
Encapsulated tablets
Drug: Placebo
encapsulated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-blind phase: AUC of TSS throughout the study
Time Frame: 28 days
Area under curve (AUC) of total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the patients' diary before randomization) to D28 visit according to the patient's assessment on reflective symptoms.
28 days
Open-label phase: Long-term safety
Time Frame: 12 months
Evaluation of the long-term safety of Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis. The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study), ECGs on M3, M6, M9 and M12 visits and routine laboratory analyses (haematology and biochemistry) performed at M3, M6, M9 and M12 visits.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of TSS since baseline to D28 according to the patient's assessment on instantaneous symptoms.
Time Frame: 28 days
28 days
Change in the TSS on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
Time Frame: Day 14 and day 28
Day 14 and day 28
Change in Nasal Symptoms Score (NSS)
Time Frame: Day 14 and day 28
Change in Nasal Symptoms Score (NSS) on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Day 14 and day 28
Change in Non Nasal Symptoms Score (NNSS)
Time Frame: Day 14 and day 28
Change in Non Nasal Symptoms Score (NNSS) on symptom scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessment (at the moment of the visits)
Day 14 and day 28
Change in individual nasal and non nasal symptoms
Time Frame: Day 14 and day 28
Change in each of the NSS or NNSS on symptoms scale on D14 and D28 visits versus D0 visit according to the patient and investigator's assessments (at the moment of the visits)
Day 14 and day 28
AUC of NSS, NNSS and each individual nasal andn non nasal symptom
Time Frame: 28 days
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on reflective symptoms
28 days
AUC of NSS, NNSS and each individual symptom according to patient's instantaneous assessment
Time Frame: 28 days
AUC of NSS, NNSS and each of the nasal and non nasal symptoms scores on symptoms scale from baseline to D28, according to the patient's assessment on instantaneous symptoms. Time to maximum relief of symptoms
28 days
Overall assessment of discomfort
Time Frame: Day 14 and day 28
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D14 and D28 visits
Day 14 and day 28
Investigator's clinical global impression
Time Frame: 28 days
28 days
Quality of Life change from baseline
Time Frame: 28 days
28 days
Responders rate
Time Frame: 28 days
Responders were classified based on their total symptom score decrease to baseline: <25%, 25%-50%, 50%-75%, >75% and were described by treatment group with their percentage and 95% confidence interval.
28 days
Time to maximum response
Time Frame: 48 hours
Time to maximum response was described using Kaplan-Meier estimates and was compared (Log-rank test) between treatment groups.
48 hours
Safety and tolerability
Time Frame: 28 days
The tolerability of the study drug was assessed by means of: Adverse events (comparing the profiles throughout the course of the study, ECGs on D0 and D28 visits and routine laboratory analyses (haematology and biochemistry) performed at D0 and D28 visits.
28 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. MD., 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

May 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILA 1503/RAP

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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