epinastine + pseudoephedrine sr (slow release) versus epinastine alone in patients with perennial allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: the aim of this trial is to evaluate the clinical efficacy and safety of epinastine 10 mg + pseudoephedrine 120 mg slow release (sr) administered twice a day, compared to epinastine 10 mg alone administered twice daily.


Eligibility criteria:
inclusion criteria: * male and female outpatients * over 12 years old * patients who have granted their written informed consent, personally or by a legal representative, to be part of the study and in accomplishment of the model of informed consent approved by the ethic committee of the institution * patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens) * patients with moderate or complete nasal blockage characterizes by ≥50 mm in the vas for this parameter during visits 1 and 2 * patients with positive (≥3 mm compared to the negative control) skin test ("prick test") to one or more of the following allergens: * dermatophagoides pteronyssinus * dermatophagoides farinae * blomia tropicalis * alternaria alternata * cladosporium herbarum * aspergillus fumigatus * penicillium notatum * cat's fur * dog's fur exclusion criteria: * pregnant or breast feeding women, or women without contraceptive method who: * are not in the postmenopausal period and/or * have not been submitted to bilateral tubal ligation or hysterectomy and/or * are not under one of the following contraceptive control: * oral contraceptive * iud (intrauterine device) * diaphragm * patients unable to understand, accept or follow the protocol instructions * history of serious adverse events with antihistamines * patients under treatment with calcium antagonists or other antihypertensive drugs * patients under treatment with digitalis * patients under treatment with mao (monoamine oxidase) inhibitors * patients under treatment with sympathicomimetics * patients that have received any of the following drugs during the periods specified below, before visit 1: * inhaled/topics * short acting β2 agonists (12 hours) * long acting β2 agonists (48 hours) * ipratropium bromide (12 hours) * nasal drops without vasoconstrictors (3 days) * dscg (disodium cromoglycate) (3 days) * nedocromil (7 days) * nasal drops with vasoconstrictors (7 days) * azelastine (14 days) * levocabastine (14 days) * corticosteroids (30 days) * corticosteroids on the site of prick test (3 months) * other investigational drug (3 months) * oral * short acting β2 agonists (18 hours) * short acting theophylline (24 hours) * phenothiazines (48 hours) * long acting theophylline (72 hours) * anticholinergics (7 days) * antihistamines (except astemizole) (7 days) * mao (monoamine oxidase) inhibitors (14 days) * corticosteroids (30 days) * ketotifen (3 months) * imipramine (30 days) * astemizole (2 months) * other investigational drugs (3 months) * parenteral * aminophylline (24 hours) * phenothiazines (48 hours) * antihistamines (7 days) * corticosteroids (30 days) * imipramine (30 days) * other investigational drugs (3 months) * patients under desensitization therapy * patients under therapy with antibiotics * patients with non compensate endocrine disease * patients with atrophic rhinitis * patients with rhinitis due to acetylsalicylic acid * patients with acute or chronic infectious sinusitis * patients with asthma, that need treatment with beta-2 agonists more than twice per week * patients with glaucoma * patients with history or renal and/or hepatic failure * patients with known platelets dysfunction due to any disease or to drugs (purpura thrombocytopenic idiopathic, use of anticoagulants, use of antiplatelets drugs) * patients with any oncological disease * patients with nasal septal deviation causing alteration of the nasal flux, polyps, anatomic/structural alterations (ex., tumors, leishmaniosis, etc.) * patients with any cardiovascular disease * patients with arterial hypertension * patients requiring halogenates anesthetics * patients with diabetes mellitus * patients with hyperthyroidism * patients with prostatic hypertrophy * patients with epilepsy or any other seizure