Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Registration Number
- NCT02182518
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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Male and female outpatients
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Over 12 years old
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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
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Patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens)
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Patients with moderate or complete nasal blockage characterizes by ≥50 mm in the VAS for this parameter during visits 1 and 2
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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
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Pregnant or breast feeding women, or women without contraceptive method who:
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are not in the postmenopausal period and/or
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have not been submitted to bilateral tubal ligation or hysterectomy and/or
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are not under one of the following contraceptive control:
- oral contraceptive
- IUD (intrauterine device)
- diaphragm
-
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Patients unable to understand, accept or follow the protocol instructions
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History of serious adverse events with antihistamines
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Patients under treatment with calcium antagonists or other antihypertensive drugs
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Patients under treatment with digitalis
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Patients under treatment with MAO (monoamine oxidase) inhibitors
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Patients under treatment with sympathicomimetics
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Patients that have received any of the following drugs during the periods specified below, before visit 1:
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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)
-
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Patients under desensitization therapy
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Patients under therapy with antibiotics
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Patients with non compensate endocrine disease
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Patients with atrophic rhinitis
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Patients with rhinitis due to acetylsalicylic acid
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Patients with acute or chronic infectious sinusitis
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Patients with asthma, that need treatment with beta-2 agonists more than twice per week
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Patients with glaucoma
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Patients with history or renal and/or hepatic failure
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Patients with known platelets dysfunction due to any disease or to drugs (purpura thrombocytopenic idiopathic, use of anticoagulants, use of antiplatelets drugs)
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Patients with any oncological disease
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Patients with nasal septal deviation causing alteration of the nasal flux, polyps, anatomic/structural alterations (ex., tumors, leishmaniosis, etc.)
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Patients with any cardiovascular disease
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Patients with arterial hypertension
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Patients requiring halogenates anesthetics
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Patients with diabetes mellitus
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Patients with hyperthyroidism
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Patients with prostatic hypertrophy
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Patients with epilepsy or any other seizure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epinastine + Pseudoephedrine Placebo - Epinastine Placebo - Epinastine + Pseudoephedrine Epinastine - Epinastine Epinastine - Epinastine + Pseudoephedrine Pseudoephedrine -
- Primary Outcome Measures
Name Time Method Incidence and severity of all adverse events up to 5 weeks 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
- Secondary Outcome Measures
Name Time Method 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 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 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 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 Classification of the severity of the symptoms by the investigator 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 pruritus symptoms evaluated by patient using VAS Baseline and at the end of weeks 1, 2, 3, 4