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Trial record 13 of 16 for:    AZD 5069

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233232
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : May 19, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 109
Recruitment Details First patient enrolled: 22 November 2010. Last patient completed: 22 March 2011. Fifteen centres across 4 countries participated in this study: Bulgaria (4), Germany (4), Hungary (4) and Ukraine (3)
Pre-assignment Details 22 patients enrolled were not randomized due to eligibility not fulfilled (17 patients) and voluntary discontinuation (5 patients)
Arm/Group Title Placebo AZD5069 50 mg AZD5069 80 mg
Hide Arm/Group Description 4 x placebo capsules, twice daily (bid) 1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid 4 x 20 AZD5069 mg capsules, bid
Period Title: Overall Study
Started 29 30 28
Completed 28 30 28
Not Completed 1 0 0
Reason Not Completed
Voluntary Discontinuation by Subject             1             0             0
Arm/Group Title Placebo AZD5069 50 mg AZD5069 80 mg Total
Hide Arm/Group Description 4 x placebo capsules, twice daily (bid) 1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid 4 x 20 AZD5069 mg capsules, bid Total of all reporting groups
Overall Number of Baseline Participants 29 30 28 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 28 participants 87 participants
62  (7.9) 65  (6.9) 65  (7.4) 64  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 28 participants 87 participants
Female
9
  31.0%
12
  40.0%
6
  21.4%
27
  31.0%
Male
20
  69.0%
18
  60.0%
22
  78.6%
60
  69.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 29 participants 30 participants 28 participants 87 participants
24.842  (2.77) 27.645  (2.89) 25.803  (3.18) 26.118  (3.14)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 29 participants 30 participants 28 participants 87 participants
73.7  (14.02) 78.9  (9.18) 75.4  (10.90) 76  (11.59)
% Predicted FEV1 at screening  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 29 participants 30 participants 28 participants 87 participants
56  (13.9) 57  (13.6) 54  (12.1) 56  (13.2)
FEV1/FVC at screening  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 29 participants 30 participants 28 participants 87 participants
52.54  (9.62) 51.75  (11.65) 54.52  (10.51) 52.91  (10.58)
Nicotine pack years   [1] 
Mean (Standard Deviation)
Unit of measure:  Pack Year
Number Analyzed 29 participants 30 participants 28 participants 87 participants
38  (21.4) 39  (22) 34  (17.9) 37  (20.4)
[1]
Measure Description: one pack year= 1 pack (20 cigrettes) per day for 1 year, or equivalent
GOLD classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 28 participants 87 participants
II Moderate 17 20 16 53
III Severe 12 10 12 34
[1]
Measure Description: The spirometric classification of severity COPD now includes four stages: Stage I: Mild; Stage II: Moderate; Stage III: Severe; Stage IV: Very Severe.
1.Primary Outcome
Title Patients Who Experienced at Least One Adverse Events(s)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 29 30 28
Measure Type: Number
Unit of Measure: Participants
9 10 6
2.Primary Outcome
Title Number of Participants With Abnormal Physical Examination Findings
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 29 30 28
Measure Type: Number
Unit of Measure: Participants
0 0 1
3.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 22 25 23
Measure Type: Number
Unit of Measure: Participants
0 0 0
4.Primary Outcome
Title Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 28 28
Mean (Standard Deviation)
Unit of Measure: 10^9/L cells/L
-0.12  (1.974) -1.55  (2.059) -1.08  (2.404)
5.Primary Outcome
Title Change From Baseline to End of Treatment for Body Temperature
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 30 28
Mean (Standard Deviation)
Unit of Measure: degrees C
-0.1  (0.43) 0.0  (0.57) -0.0  (0.39)
6.Primary Outcome
Title Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 30 28
Mean (Standard Deviation)
Unit of Measure: mmHg
3.0  (11.0) -0.0  (12.1) -3.0  (15.7)
7.Primary Outcome
Title Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 30 28
Mean (Standard Deviation)
Unit of Measure: mmHg
2.0  (7.2) -2.0  (7.9) -1.0  (8.2)
8.Primary Outcome
Title Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 30 28
Mean (Standard Deviation)
Unit of Measure: beats/minute
1  (6.2) -1  (6.9) 3  (7.9)
9.Primary Outcome
Title Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 28 30 27
Mean (Standard Deviation)
Unit of Measure: L
-0.03  (0.238) 0.05  (0.238) -0.01  (0.218)
10.Primary Outcome
Title Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 27 30 28
Mean (Standard Deviation)
Unit of Measure: L
-0.02  (0.230) 0.10  (0.256) 0.02  (0.194)
11.Primary Outcome
Title Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)
Hide 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])
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 29 30 28
Measure Type: Number
Unit of Measure: Participants
0 0 0
12.Primary Outcome
Title Change From Baseline to End of Treatment for Total Protein (Urinalysis)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 6 4 1
Mean (Standard Deviation)
Unit of Measure: g/L
-0.02  (0.034) -0.01  (0.022) -0.01 [1]   (NA)
[1]
Only one value in arm 3. SD is not calculable.
13.Secondary Outcome
Title Plasma Concentration of AZD5069 After 1 Hour of Dosing
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 0 18 18
Mean (Standard Deviation)
Unit of Measure: nmol/L
2599.551  (2085.601) 5433.611  (4622.932)
14.Secondary Outcome
Title Area Under the Plasma Concentration Curve of AZD5069
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 26 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
29600
(4270% to 136000%)
38800
(6700% to 143000%)
15.Secondary Outcome
Title Maximum Plasma Concentration for AZD5069
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 26 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
2550
(367% to 11700%)
3340
(576% to 12300%)
16.Secondary Outcome
Title Time to Maximum Plasma Concentration for AZD5069
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 26 22
Median (Inter-Quartile Range)
Unit of Measure: hours
1.56
(1.56 to 1.56)
1.56
(1.56 to 1.56)
17.Secondary Outcome
Title Maximum Reduction of Circulating Neutrophils in Blood, From Baseline
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Placebo Arm 2 - AZD5069 50 mg Arm 3 - AZD5069 80 mg
Hide Arm/Group Description:
4 x placebo capsules, twice daily (bid)
1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
4 x 20 AZD5069 mg capsules, bid
Overall Number of Participants Analyzed 22 30 26
Mean (Standard Deviation)
Unit of Measure: 10^9/L cells/L
1.324  (1.2152) 2.759  (1.4422) 2.678  (2.0710)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo AZD5069 50 mg AZD5069 80 mg
Hide Arm/Group Description 4 x placebo capsules, twice daily (bid) 1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid 4 x 20 AZD5069 mg capsules, bid
All-Cause Mortality
Placebo AZD5069 50 mg AZD5069 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo AZD5069 50 mg AZD5069 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   1/30 (3.33%)   1/28 (3.57%) 
Cardiac disorders       
Atrial Fibrillation  0/29 (0.00%)  1/30 (3.33%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  0/29 (0.00%)  0/30 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo AZD5069 50 mg AZD5069 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/29 (10.34%)   8/30 (26.67%)   1/28 (3.57%) 
Gastrointestinal disorders       
Diarrhoea  1  1/29 (3.45%)  2/30 (6.67%)  0/28 (0.00%) 
General disorders       
Pyrexia  1  2/29 (6.90%)  1/30 (3.33%)  0/28 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  2/29 (6.90%)  4/30 (13.33%)  0/28 (0.00%) 
Investigations       
Neutrophil Count Decreased  1  0/29 (0.00%)  3/30 (10.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  0/29 (0.00%)  2/30 (6.67%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01233232     History of Changes
Other Study ID Numbers: D3550C00002
2010-021217-23 ( EudraCT Number )
First Submitted: November 2, 2010
First Posted: November 3, 2010
Results First Submitted: April 30, 2015
Results First Posted: May 19, 2015
Last Update Posted: September 17, 2015