Rhinitis, Allergic, Perennial
Conditions
Brief 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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 patient using VAS | 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 investigator | 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 |
| 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 |
Outcome results
None listed