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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Epinastine
* Drug: Pseudoephedrine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epinastine + Pseudoephedrine<br> | Drug: Epinastine<br> <br> Drug: Pseudoephedrine<br> <br> Drug: Placebo<br>* Placebo during run-in period<br>|
| Experimental: Epinastine<br> | Drug: Epinastine<br> <br> Drug: Placebo<br>* Placebo during run-in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of severity of nasal blockage by Visual Analog Scale (VAS) |  | at the end of weeks 1, 2, 3, 4 | 
| Incidence of laboratory alterations |  | day 14, 28 and 35 | 
| Incidence of premature discontinuations of the study due to adverse events |  | up to 4 weeks | 
| Incidence and severity of all adverse events |  | up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily evaluation of the nasal blockage by the patient |  | daily up to 4 weeks | 
| Classification of the severity of the symptoms by the investigator |  | at the end of weeks 1, 2, 3, 4 | 
| Changes in nasal physical examination |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in rhinorrhea symptoms evaluated by investigator |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in pruritus symptoms evaluated by investigator |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in sneezing symptoms evaluated by investigator |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in lacrimation symptoms evaluated by investigator |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in rhinorrhea symptoms evaluated by patient using VAS |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in pruritus symptoms evaluated by patient using VAS |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in sneezing symptoms evaluated by patient using VAS |  | Baseline and at the end of weeks 1, 2, 3, 4 | 
| Changes in lacrimation symptoms evaluated by patient using VAS |  | Baseline and at the end of weeks 1, 2, 3, 4 |