A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115
 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115
 including investigations of clinically relevant systemically mediated effects will also be
 investigated.
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over,
 single-dose Phase IIa study to investigate the local and systemic effects of 3 different
 doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)
Inclusion Criteria:

 -  Provision of informed consent prior to any study specific procedures

 -  Male or female of non-childbearing potential (post-menopausal or surgically
 sterilised), age ≥40 years at Visit 1

 -  Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD
 guidelines

 -  Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value and
 post-bronchodilator FEV1/FVC < 70%

 -  Reversible airway obstruction

 Exclusion Criteria:

 -  Significant disease or disorder which, in the opinion of the Investigator, may either
 put the patient at risk because of participation in the study, or influence the result
 of the study, or the patient's ability to participate in the study.

 -  An exacerbation of COPD within 6 weeks prior to Visit 1

 -  Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.

 -  Recent or ongoing respiratory tract infection during enrolment period.

 -  Need for long-term oxygen therapy and/or saturation O2 < 92%.