EUCTR2014-002275-28-BG进行中（未招募）1 期
A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO] - DYNAGITO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8,200
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
- •- Male or female patients, 40 years of age or older.
- •- Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/FVC (Forced vital capacity) <70% at Visit 1
- •For patients participating in the spirometry sub-study, historical data will not be used for inclusion. These patients will perform a pre-dose pulmonary function test which will be followed by the administration of 400 µg salbutamol / albuterol followed by a post-dose pulmonary function test for qualification.
- •- Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
- •- Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
- •- Current or ex-smokers with a smoking history of more than 10 pack years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2300
排除标准
- •- Significant disease other than COPD.
- •- Clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine > x2 ULN will be excluded regardless of clinical condition
- •- Current documented history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
- •- A diagnosis of thyrotoxicosis
- •- A history of myocardial infarction within 6 months of screening visit.
- •- Life-threatening cardiac arrhythmia.
- •- Known active tuberculosis.
- •- Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
- •- A history of cystic fibrosis.
- •- Clinically relevant bronchiectasis.
- •- Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
- •- A history of significant alcohol or drug abuse in the opinion of the investigator.
- •- Patients who have undergone thoracotomy with pulmonary resection
- •- Patients being treated with oral or patch ß-adrenergics.
- •- Patients being treated with oral corticosteroid medication at unstable doses
- •- Patients being treated with antibiotics for any reason (not limited to exacerbation infection) within 4 weeks of screening visit.
- •- Patients being treated with PDE4 inhibitors within 3 months of screening visit
- •- Patients who have taken an investigational drug within one month or six half-lives
- •- Pregnant or nursing women.
- •- Women of childbearing potential not using a highly effective method of birth control.
研究者
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