Status:
COMPLETED
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
Lead Sponsor:
AstraZeneca
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 inves...
Detailed Description
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 AZD...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01498081
Start Date
March 1 2012
End Date
October 1 2012
Last Update
October 26 2012
Active Locations (6)
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1
Research Site
Bialystok, Poland
2
Research Site
Lodz, Poland
3
Research Site
Proszowice, Poland
4
Research Site
Łęczna, Poland