Back to resultsA 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (CIRRUS)
Primary Purpose
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD), Laymen Terminology Chronic Bronchitis and Emphysema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
AZD5069 50mg
AZD5069 80mg
Sponsored by
About this trial
This is an interventional treatment trial for Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Placebo dose
Treatment arm AZD5069 50mg
Treatment arm AZD5069 80mg
Outcomes
Primary Outcome Measures
Patients Who Experienced at Least One Adverse Events(s)
Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Number of Participants With Abnormal Physical Examination Findings
Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
Number of Participants With Abnormal Electrocardiogram (ECG)
ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).
Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)
The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for Body Temperature
The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)
The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)
The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)
The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)
The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)
The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)
High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).
Change From Baseline to End of Treatment for Total Protein (Urinalysis)
The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
Secondary Outcome Measures
Plasma Concentration of AZD5069 After 1 Hour of Dosing
At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.
Area Under the Plasma Concentration Curve of AZD5069
The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.
Maximum Plasma Concentration for AZD5069
The maximum plasma concentration (Cmax) is the highest level of drug in plasma.
Time to Maximum Plasma Concentration for AZD5069
Time (in relation to dosing) at which the maximum plasma concentration is observed.
Maximum Reduction of Circulating Neutrophils in Blood, From Baseline
The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01233232
Brief Title
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Acronym
CIRRUS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD), Laymen Terminology Chronic Bronchitis and Emphysema
Keywords
Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo dose
Arm Title
2
Arm Type
Experimental
Arm Description
Treatment arm AZD5069 50mg
Arm Title
3
Arm Type
Experimental
Arm Description
Treatment arm AZD5069 80mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral dose bid
Intervention Type
Drug
Intervention Name(s)
AZD5069 50mg
Intervention Description
Oral dose bid
Intervention Type
Drug
Intervention Name(s)
AZD5069 80mg
Intervention Description
Oral dose bid
Primary Outcome Measure Information:
Title
Patients Who Experienced at Least One Adverse Events(s)
Description
Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Time Frame
From start of treatment (Day 0) up to 28 days (End of Treatment)
Title
Number of Participants With Abnormal Physical Examination Findings
Description
Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
Time Frame
Last Observation on Treatment (up to Day 28)
Title
Number of Participants With Abnormal Electrocardiogram (ECG)
Description
ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)
Description
The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for Body Temperature
Description
The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)
Description
The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)
Description
The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)
Description
The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)
Description
The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)
Description
The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Title
Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)
Description
High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).
Time Frame
Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])
Title
Change From Baseline to End of Treatment for Total Protein (Urinalysis)
Description
The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
Time Frame
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Secondary Outcome Measure Information:
Title
Plasma Concentration of AZD5069 After 1 Hour of Dosing
Description
At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.
Time Frame
End of Treatment (Day 28), 1 hour after dosing
Title
Area Under the Plasma Concentration Curve of AZD5069
Description
The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.
Time Frame
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
Title
Maximum Plasma Concentration for AZD5069
Description
The maximum plasma concentration (Cmax) is the highest level of drug in plasma.
Time Frame
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
Title
Time to Maximum Plasma Concentration for AZD5069
Description
Time (in relation to dosing) at which the maximum plasma concentration is observed.
Time Frame
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
Title
Maximum Reduction of Circulating Neutrophils in Blood, From Baseline
Description
The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
GROßHANSDORF
Country
Germany
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Pécs
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Százhalombatta
Country
Hungary
Facility Name
Research Site
City
Kyiv
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
25681277
Citation
Kirsten AM, Forster K, Radeczky E, Linnhoff A, Balint B, Watz H, Wray H, Salkeld L, Cullberg M, Larsson B. The safety and tolerability of oral AZD5069, a selective CXCR2 antagonist, in patients with moderate-to-severe COPD. Pulm Pharmacol Ther. 2015 Apr;31:36-41. doi: 10.1016/j.pupt.2015.02.001. Epub 2015 Feb 11.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=208&filename=D3550C00002_Revised_Clinical_Study_Protocol.pdf
Description
D3550C00002_Revised_Clinical_Study_Protocol.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=208&filename=D3550C00002_Study_Synopsis.pdf
Description
D3550C00002_Study_Synopsis.pdf
Learn more about this trial
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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