A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 Âµg and 5 Âµg Tiotropium Inhalation Solution delivered by the RespimatÂ® Inhaler with Tiotropium inhalation capsules 18 Âµg delivered by the HandiHalerÂ®. - Tiotropium Safety and Performance In RESPIMAT (TIOSPIR)

Boehringer Ingelheim0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年5月6日

适应症

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.
•4.All patients must have a diagnosis of COPD (according to definition in protocol page 26)
•5.Patients must be able to inhale from the HandiHaler® and the Respimat® devices.

•1.Significant diseases other than COPD. (see protocl for definitions)
•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. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
•6. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
•7. Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg) prednisolone per day

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