NCT02182518已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Incidence and severity of all adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
- 另有 15 项未显示
研究组 & 干预措施
Epinastine + Pseudoephedrine
Experimental
干预措施: Epinastine (Drug)
Epinastine + Pseudoephedrine
Experimental
干预措施: Pseudoephedrine (Drug)
Epinastine + Pseudoephedrine
Experimental
干预措施: Placebo (Drug)
Epinastine
Experimental
干预措施: Epinastine (Drug)
Epinastine
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of all adverse events
时间窗: up to 5 weeks
Classification of severity of nasal blockage by Visual Analog Scale (VAS)
时间窗: at the end of weeks 1, 2, 3, 4
Incidence of laboratory alterations
时间窗: day 14, 28 and 35
Incidence of premature discontinuations of the study due to adverse events
时间窗: up to 4 weeks
次要结局
- 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)
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