A RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP DESIGN, MULTI-CENTER TRIAL TO COMPARE THE EFFICACY AND SAFETY OF 2.5 µG AND 5 µG TIOTROPIUM INHALATION SOLUTION DELIVERED BY THE RESPIMAT INHALER WITH TIOTROPIUM INHALATION CAPSULES 18 µG DELIVERED BY THE HANDIHALER

Boehringer Ingelheim,0 个研究点目标入组 105 人开始时间: 2010年8月10日最近更新: 2023年9月4日

试验速览

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•1.All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
•2.Male or female patients 40 years of age or older.
•3.Patients must be current or ex-smokers with a smoking history of ≥10 pack-years. (Patients who have never smoked cigarettes must be excluded).
•4.All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 ≤ 70% of predicted normal and post-bronchodilator FEV1 / FVC ≤70%. Pulmonary function tests (PFTs) were conducted after the inhalation of 400 μg salbutamol / albuterol (preferred), however testing with either 200 μg salbutamol/albuterol or a combination of salbutamol/ albuterol with ipratropium bromide (2 to 4 actuations) was acceptable. Other short-acting beta agonists, such as terbutaline, may have been used for the testing. The medication used for the testing was documented. Further, historical data from measurements within the past 6 months either at the site or at a referral site may have been used (see Section 6.2.1 of the CTP, located in Appendix 16.1.1). Subjects were not to have been randomized to the study without the availability of spirometry data at the actual study site. Eligibility for PFT sub-study:

•1.Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
•2.Patients with a recent history (i.e., six months or less) of myocardial infarction.
•3.Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
•4.Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
•5.Known active tuberculosis.
•6.Patients with a history of asthma, cystic fibrosis, clinically evident bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
•7.History of thoracotomy with pulmonary resection. Subjects with a history of thoracotomy for other reasons were to have been evaluated per exclusion criterion 1.
•8.Subject was planning to undergo lung transplant or lung volume reduction surgery (LVRS).
•9.Malignancy for which the subject had undergone resection, radiation, chemotherapy or biological treatments within the last 5 years. Subjects with treated basal cell carcinoma were allowed.
•10.Known respiratory infection or exacerbation of COPD in the 4 weeks prior to randomization.

发起方

Boehringer Ingelheim,