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

nilfarma, Lda.0 个研究点目标入组 9,009 人开始时间: 2014年11月10日最近更新: 2019年12月10日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 9,009

研究概览入排标准研究者记录与标识符相似试验

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

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 need to qualify in the clinic at Visit 1 after performing a baseline measurement. 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 800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7000

排除标准

•- Significant disease other than COPD.
•- Clinically relevant abnormal baseline haematology, blood chemistry, or creatinine > x2 ULN will be excluded regardless of clinical condition
•- Current documented diagnosis 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

发起方

nilfarma, Lda.

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