Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis

Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhinitis

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.

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