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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01233232
First received: November 2, 2010
Last updated: April 30, 2015
Last verified: April 2015
Results First Received: April 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
Laymen Terminology Chronic Bronchitis and Emphysema
Interventions: Drug: Placebo
Drug: AZD5069 50mg
Drug: AZD5069 80mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 22 November 2010. Last patient completed: 22 March 201. Fifteen centres across 4 countries participated in this study: Bulgaria (4), Germany (4), Hungary (4) and Ukraine (3)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
22 patients enrolled were not randomized due to eligibility not fulfilled (17 patients) and voluntary discontinuation (5 patients)

Reporting Groups
  Description
Placebo 4 x placebo capsules, twice daily (bid)
AZD5069 50 mg 1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
AZD5069 80 mg 4 x 20 AZD5069 mg capsules, bid

Participant Flow:   Overall Study
    Placebo     AZD5069 50 mg     AZD5069 80 mg  
STARTED     29     30     28  
COMPLETED     28     30     28  
NOT COMPLETED     1     0     0  
Voluntary Discontinuation by Subject                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 4 x placebo capsules, twice daily (bid)
AZD5069 50 mg 1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
AZD5069 80 mg 4 x 20 AZD5069 mg capsules, bid
Total Total of all reporting groups

Baseline Measures
    Placebo     AZD5069 50 mg     AZD5069 80 mg     Total  
Number of Participants  
[units: participants]
  29     30     28     87  
Age  
[units: Years]
Mean (Standard Deviation)
  62  (7.9)     65  (6.9)     65  (7.4)     64  (7.4)  
Gender  
[units: Participants]
       
Female     9     12     6     27  
Male     20     18     22     60  



  Outcome Measures
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1.  Primary:   Patients Who Experienced at Least One Adverse Events(s)   [ Time Frame: From start of treatment (Day 0) up to 28 days (End of Treatment) ]

2.  Primary:   Number of Participants With Abnormal Physical Examination Findings   [ Time Frame: Last Observation on Treatment (up to Day 28) ]

3.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

4.  Primary:   Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

5.  Primary:   Change From Baseline to End of Treatment for Body Temperature   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

6.  Primary:   Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

7.  Primary:   Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

8.  Primary:   Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

9.  Primary:   Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

10.  Primary:   Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

11.  Primary:   Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)   [ Time Frame: Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28]) ]

12.  Primary:   Change From Baseline to End of Treatment for Total Protein (Urinalysis)   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ]

13.  Secondary:   Plasma Concentration of AZD5069 After 1 Hour of Dosing   [ Time Frame: End of Treatment (Day 28), 1 hour after dosing ]

14.  Secondary:   Area Under the Plasma Concentration Curve of AZD5069   [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing      ]

15.  Secondary:   Maximum Plasma Concentration for AZD5069   [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing ]

16.  Secondary:   Time to Maximum Plasma Concentration for AZD5069   [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing ]

17.  Secondary:   Maximum Reduction of Circulating Neutrophils in Blood, From Baseline   [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01233232     History of Changes
Other Study ID Numbers: D3550C00002, 2010-021217-23
Study First Received: November 2, 2010
Results First Received: April 30, 2015
Last Updated: April 30, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency
Germany: National Regulatory Authority - BfArM (Bundesinstitut fur Arzneimittel und Medizinpordukte)
Hungary: National Institute of Pharmacy
Ukraine: Ministry of Healthcare of Ukraine The State Pharmacological Centre of Ministry of Health