A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Tiotropium Bromide

Criteria

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%.