A single-dose study to investigate the effects of 3 different doses of inhaled AZD2115 in COPD patients

• Conditions: AZD2115 is being developed to treat chronic obstructive pulmonary disease (COPD).; MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004641-41-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-21
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified