A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (CIRRUS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01233232
First received: November 2, 2010
Last updated: April 1, 2011
Last verified: April 2011

November 2, 2010
April 1, 2011
November 2010
March 2011   (final data collection date for primary outcome measure)
Safety and tolerability variables (Adverse Events, ECG, physical examination, safety blood samples, vital signs, body temperature, lung function tests) [ Time Frame: Weekly safety measurements during the study from screening period to follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01233232 on ClinicalTrials.gov Archive Site
  • AZD5069 concentration in plasma and resulting PK parameters [ Time Frame: From first dose until 5 hours after the last dose ] [ Designated as safety issue: No ]
  • Levels of circulating neutrophils in blood [ Time Frame: From first dose until 5 hours after the last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
  • Laymen Terminology Chronic Bronchitis and Emphysema
  • Drug: Placebo
    Oral dose bid
  • Drug: AZD5069 50mg
    Oral dose bid
  • Drug: AZD5069 80mg
    Oral dose bid
  • Placebo Comparator: 1
    Placebo dose
    Intervention: Drug: Placebo
  • Experimental: 2
    Treatment arm AZD5069 50mg
    Intervention: Drug: AZD5069 50mg
  • Experimental: 3
    Treatment arm AZD5069 80mg
    Intervention: Drug: AZD5069 80mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of COPD with symptoms for more than one year before screening
  • Body mass index of 18-30 kg/m2 and weight of 50-100kg
  • Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
  • FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
  • FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Exacerbation of COPD which was not resolved within 30 days of first dosing
  • Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
  • Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
  • Disease history suggesting reduced or abnormal immune function other than that related to COPD
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Germany,   Hungary,   Ukraine
 
NCT01233232
D3550C00002, 2010-021217-23
Not Provided
Joher Raniwalla/Medical Science Director, AstraZeneca R&D, Alderley Park
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP