Clinical trial NCT01127620 (phase 3, status: completed)
Conditions: perennial allergic rhinitis
ICD codes: D69.0, L50.0, B44.81, J30.89, J30.9, L20.84, H10.45
Drugs: bilastine, cetirizine, placebo
SMILES: CCOCCN1C(=NC2=CC=CC=C12)C1CCN(CCC2=CC=C(C=C2)C(C)(C)C(O)=O)CC1, OC(=O)COCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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