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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faes Farma, S.A.
• Treatments: Cetirizine

Criteria

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