EUCTR2019-004095-19-BG进行中（未招募）1 期
A pharmacodynamic, randomised, single dose, cross-over study to compare the bronchodilator effect of a new formulation of Tiotropium DPI versus Spiriva® 18 µg Handihaler®
aboratoires SMB S.A.0 个研究点目标入组 66 人开始时间: 2019年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- •nclusion criteria
- •Patients must satisfy the following criteria before entering the study:
- •1.Male and non-pregnant female aged over 40 years old
- •2.Documented history of stable COPD with moderate to severe airflow obstruction diagnosed for more than six months according to the GOLD standard prior to the screening visit
- •3.FEV1 more than or equal to 30% and inferior to 80% of predicted at screening.
- •4.FEV1/FVC following 200 µg salbutamol treatment intake < 0.7 at screening.
- •5.Reversibility of at least 12% and 100 ml in FEV1 30-45 minutes after maximum 400 µg of salbutamol
- •6.Current smokers or history of ex-smokers (=10 pack-year smoking history).
- •7.Able to comply with all study procedures, including the use of study inhalers and spirometer
- •8.Provide written informed consent to participate in the study, indicated by a personal signature and date on the patient consent form
- •Are the trial subjects under 18? no
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •Exclusion criteria
- •Patients who meet any of the following criteria will be excluded from participating in the study:
- •1.Evidence of any unstable or untreated clinically significant immunological, cardiac, cardiovascular, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormality or disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk during her/his participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study
- •2.Respiratory tract infection or COPD exacerbation not completely resolved within the last 2 weeks prior to the screening visit or between the screening and the randomization
- •3.Abnormality of inspiratory function (e.g. laryngeal obstruction, neuromuscular disease)
- •4.Need for daily oxygen therapy
- •5.Asthma, allergic rhinitis, cystic fibrosis, bronchiolitis obliterans, fibrosis, active or latent tuberculosis, a1-antitrypsin deficiency or any other causes of chronic airflow limitation apart from COPD
- •6.Use of any of the prohibited medications as detailed in the concomitant medication section
- •7.Patients with any sensitivity or allergy to any of the products used within this clinical trial
- •8.Female pregnant, breast-feeding or of childbearing potential age without efficient means of birth control (IUD, OCS, implants, hormonal patch, vaginal ring or spermicide and condom)
- •9.Patients with human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV)
- •10.Participation in any investigational medical studies within 2 month prior the screening visit
研究者
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