Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety … (NCT01127620) | Clinical Trial Compass
CompletedPhase 3
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
650 participantsStarted 2004-05
Plain-language 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
Who can participate
Age range12 Years – 70 Years
SexALL
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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…
What they're measuring
1
Double-blind phase: AUC of TSS throughout the study