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Clinical Trials/EUCTR2011-004641-41-SE
EUCTR2011-004641-41-SEActive, not recruitingNot Applicable

A randomised, double-blind, placebo-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 compared with active comparators, in patients with chronic obstructive pulmonary disease (COPD) - AZD2115 SDXO study

AstraZeneca AB0 sites36 target enrollmentStarted: December 21, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
36
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 18
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 18

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%

Investigators

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EUCTR2011-004641-41-PLAstraZeneca AB36