EUCTR2006-000683-84-HU进行中（未招募）不适用
A DOUBLE BLIND, DOUBLE DUMMY, GROUP COMPARATIVE STUDY TO ASSESS THERAPEUTIC EQUIVALENCE OF A NEW GENERIC FORMOTEROL 12 uG DRY POWDER FORMULATION WITH OXIS 12uG TURBUHALER IN ADOLESCENT AND ADULT ASTHMATIC PATIENTS
Andi-Ventis Ltd.0 个研究点目标入组 200 人开始时间: 2006年2月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At study entry:
- •1.Subject has given written informed consent.
- •2.Female or male subject from 16 - 65 years of age.
- •3.Documented history of asthma for at least 6 months at the Screening Visit
- •4.Concurrent use of a short acting inhaled ß2-agonist for symptom relief and
- •inhaled corticosteroids as maintenance treatment.
- •5.Have an FEV1 >40% of the predicted normal FEV1 after withholding short-acting inhaled ß-agonists
- •for at least 6 hours and long-acting ß-agonists for 24 hours.
- •6.Subjects who demonstrate at study entry airway reversibility (increase in FEV1 > 12.00%
- •of the predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15 minutes following inhalation of 1 dose of 12ug formoterol from Oxis Turbuhaler ® after withholding
- •short-acting inhaled ß-agonists for at least 6 hours and long-acting ß2-agonists for 24 hours.
- •7.Have a Peak Inspiratory Flow between 30 and 90 L/min inclusive measured with the IN-Check device.
- •8.Subjects are able to use dry powder inhalers with a satisfactory technique.
- •9.Subjects are able to use the peak flow meter correctly and can produce reliable PEFR readings.
- •10.Subjects are able to fill in and maintain a Diary Card.
- •11.Subjects are able to fill in a Questionnaire related to usability of the inhalers.
- •12.In the opinion of the investigator, subjects understand the trial procedures and are willing to complete the diary card.
- •At start of treatment:
- •1. Subjects with an FEV1 of at least 40% predicted normal value for age, height and
- •gender after withholding short acting ß2-agonists for 6 hours and long acting
- •ß2-agonists for the duration of the baseline period..
- •2. Subjects who demonstrate airway reversibility (increase in FEV1 >12.00% of the
- •predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15
- •minutes following inhalation of the first doses of study medication after withholding
- •short-acting inhaled ß2-agonists for at least 6 hours and long-acting ß2-agonists
- •for the duration of the baseline period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At study entry:
- •1.Patients currently receiving oral corticosteroid therapy or who have received oral
- •corticosteroid therapy in the 3 months prior to the start of this study, or who have received
- •more than three short courses of oral corticosteroid therapy in the last year.
- •2.Patient currently receiving the following medications:
- •-Anticholinergics
- •-Theophylline and other methylxanthines
- •-Use of Monoamine-Oxidase inhibitors or tricyclic antidepressants.
- •-Use of beta-receptor blocking agents like beta-blocking anti-hypertensive products.
- •-Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit.
- •-Use of long-acting ß2-agonists during the baseline period.
- •3.Patients currently receiving therapy for an upper respiratory tract infection or who have
- •received such a therapy in the month prior to the start of the study.
- •4.Patients who have been hospitalised or received emergency treatment for an exacerbation
- •of asthma in the 3 months prior to the start of the study.
- •5.Patients with a known or suspected hypersensitivity to formoterol, salbutamol or lactose.
- •6.Heavy smokers >10 cigarettes per day or ex-smokers who smoked more than 10 pack years.
- •7.Patients with any of the following concurrent conditions:
- •Uncontrolled diabetes mellitus
- •Evidence or history of neoplastic disease other than basal cell carcinoma
- •Evidence or history of tuberculosis
- •Evidence or history of significant cardiovascular disease
- •Respiratory disorders other than asthma or rhinitis
- •Clinically significant hepatic or renal disease
- •Evidence or history of alcohol or drug abuse
- •8.Women who are pregnant or lactating. Women of child bearing potential and who are not taking adequate contraceptive precautions which were started at least 3 months prior to participation in the study.
- •9.Patients who are unlikely to be compliant, take their medication as directed, complete the diary card or attend scheduled clinic visits as required.
- •10.Patients currently receiving other investigational medication or who have received investigational medication in the month prior to the start of the study.
- •11.Patients previously randomised into this study.
- •12.Employees of Andi-Ventis or CRO responsible for the execution of the study.
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