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

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

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Gender

ALL

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