- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233232
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (CIRRUS)
August 27, 2015 updated by: AstraZeneca
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sofia, Bulgaria
- Research Site
-
-
-
-
-
Berlin, Germany
- Research Site
-
GROßHANSDORF, Germany
- Research Site
-
-
-
-
-
Debrecen, Hungary
- Research Site
-
Pécs, Hungary
- Research Site
-
Szeged, Hungary
- Research Site
-
Százhalombatta, Hungary
- Research Site
-
-
-
-
-
Kyiv, Ukraine
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo dose
|
Oral dose bid
|
Experimental: 2
Treatment arm AZD5069 50mg
|
Oral dose bid
|
Experimental: 3
Treatment arm AZD5069 80mg
|
Oral dose bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients Who Experienced at Least One Adverse Events(s)
Time Frame: From start of treatment (Day 0) up to 28 days (End of Treatment)
|
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.
|
From start of treatment (Day 0) up to 28 days (End of Treatment)
|
Number of Participants With Abnormal Physical Examination Findings
Time Frame: Last Observation on Treatment (up to Day 28)
|
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.
|
Last Observation on Treatment (up to Day 28)
|
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)
|
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).
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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)
|
The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
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])
|
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).
|
Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])
|
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)
|
The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
|
Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Concentration of AZD5069 After 1 Hour of Dosing
Time Frame: End of Treatment (Day 28), 1 hour after dosing
|
At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.
|
End of Treatment (Day 28), 1 hour after dosing
|
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
|
The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.
|
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 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
|
The maximum plasma concentration (Cmax) is the highest level of drug in plasma.
|
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
|
Time to Maximum Plasma Concentration for AZD5069
Time Frame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
|
Time (in relation to dosing) at which the maximum plasma concentration is observed.
|
End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
|
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)
|
The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value.
Only participants with reduction are considered.
|
Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 2, 2010
First Submitted That Met QC Criteria
November 2, 2010
First Posted (Estimate)
November 3, 2010
Study Record Updates
Last Update Posted (Estimate)
September 17, 2015
Last Update Submitted That Met QC Criteria
August 27, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3550C00002
- 2010-021217-23 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
-
University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Reham Mohammed ElmorshedyCompletedChronic Obstructive Pulmonary Disease(COPD)Egypt
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Virginia Commonwealth UniversityFisher and Paykel HealthcareCompletedChronic Obstructive Pulmonary Disease(COPD)United States
-
Beaumont HospitalAerogenCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | Copd Exacerbation AcuteIreland
-
Medtronic BRCUnknownCOPD | COPD Exacerbation
-
Chiesi Farmaceutici S.p.A.CompletedModerate to Severe Chronic Obstructive Pulmonary Disease (COPD)Bulgaria, Germany, Hungary, Poland, Russian Federation, United Kingdom
-
Chiesi Farmaceutici S.p.A.CompletedChronic Obstructive Pulmonary Disease (COPD) | COPDUnited Kingdom
-
Elpen Pharmaceutical Co. Inc.Completed
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States