Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat® inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler® in patients with Chronic Obstructive Pulmonary Disease (COPD) - ENERGITO

Boehringer Ingelheim AB0 个研究点目标入组 308 人开始时间: 2013年8月12日最近更新: 2015年9月28日

适应症

试验速览

暂无简介。

•1. Diagnosis of chronic obstructive pulmonary disease
•2. Relatively stable airway obstruction with a post-bronchodilator 30% 3. Male or female patients, 40 years of age or older
•4. Smoking history of more than 10 pack years
•5. Ability to perform technically acceptable pulmonary function tests and maintain records
•6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)
•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 114
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 114

•1. Significant disease other than COPD
•2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
•3. Clinically relevant abnormal lab values
•4. History of asthma
•5. Diagnosis of thyrotoxicosis
•6. Diagnosis of paroxysmal tachycardia
•7.History of myocardial infarction
•8. Unstable or life-threatening cardiac arrhythmia
•9. Hospitalization for heart failure within the past year
•10. Known active tuberculosis
•11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
•12. History of life-threatening pulmonary obstruction
•13.History of cystic fibrosis
•14. Clinically evident bronchiectasis
•15.History of significant alcohol or drug abuse
•16. History of thoracotomy with pulmonary resection
•17. oral or patch ß-adrenergics
•18. Oral corticosteroid medication within 6 weeks prior to Visit 1
•19. Regular use daytime oxygen therapy for more than one hour per day
•20. Pulmonary rehabilitation program in the six weeks prior to the screening visit
•21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
•22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
•23. Pregnant or nursing women

发起方