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

November 2, 2010
April 30, 2015
November 2010
March 2011   (final data collection date for primary outcome measure)
  • Patients Who Experienced at Least One Adverse Events(s) [ Time Frame: From start of treatment (Day 0) up to 28 days (End of Treatment) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Last Observation on Treatment (up to Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28]) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28) ] [ Designated as safety issue: Yes ]
    The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
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 ]
Complete list of historical versions of study NCT01233232 on ClinicalTrials.gov Archive Site
  • Plasma Concentration of AZD5069 After 1 Hour of Dosing [ Time Frame: End of Treatment (Day 28), 1 hour after dosing ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing      ] [ Designated as safety issue: No ]
    The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.
  • Maximum Plasma Concentration for AZD5069 [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing ] [ Designated as safety issue: No ]
    The maximum plasma concentration (Cmax) is the highest level of drug in plasma.
  • Time to Maximum Plasma Concentration for AZD5069 [ Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing ] [ Designated as safety issue: No ]
    Time (in relation to dosing) at which the maximum plasma concentration is observed.
  • 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) ] [ Designated as safety issue: Yes ]
    The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.
  • 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 ]
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
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2015

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