A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2007年11月15日最近更新: 2023年9月4日

适应症

试验速览

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•Male adults and women> 40 years of age who have signed the informed consent form before the start of any procedure related to the study (which includes any adjustment of their current treatment for COPD - see Section 6.6.5.5.)
•Cooperative outpatients diagnosed with COPD (moderate to severe according to the classification of the GOLD guidelines, 2006) and:
• Smoking history of at least 10 packets-year
• Post-bronchodilator VEF1 <80% and> 30% of the predictive normal value.
• VEF1 / CVF Post-bronchodilator <70%

•Pregnant women, breastfeeding mothers or women with reproductive potential, regardless of whether they are sexually active or not, if they are not going to use acceptable methods of contraception.
•Patients who have been hospitalized for an exacerbation of their airway disease within 6 weeks prior to visit 1 or between visit 1 and 2.
•Patients with a history of asthma.
•Patients with acute respiratory tract infection within 4 weeks prior to visit 1, will not be able to enter the study.
•Other clinically significant conditions that may interfere with the conduct of the study or with patient safety, as specified in the protocol. (For a complete listing of the exclusion criteria refer to Section 5.1)

发起方

OVARTIS BIOSCIENSES PERU S.A.,