Efficacy and safety of four doses of glycopyrronium bromide in patients with stable COPD, in comparison to an active comparator tiotropium.

ovartis Pharma K.K.0 个研究点目标入组 73 人开始时间: 2007年7月25日最近更新: 2023年10月17日

适应症

试验速览

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•-Male or female adults aged >=40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
•-Patients with moderate to severe COPD according to the GOLD Guidelines (2006).
•-Patients who have smoking history of at least 10 pack years.
•-Patients with a post-bronchodilator FEV1 >=30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2.
•Exclusion criteria:
•-Pregnant women or nursing mothers and females of childbearing potential who do not use a reliable contraceptive method.
•-Patients requiring oxygen therapy on a daily basis for chronic hypoxemia
•-Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period.
•-Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
•-Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition
•-Patients with a history of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3, or onset of symptoms prior to age 40 years.
•-Patients contraindicated for tiotropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.

发起方

ovartis Pharma K.K.