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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Bulgaria
      • Sofia, Bulgaria
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • GROßHANSDORF, Germany
        • Research Site
  • Hungary
      • Debrecen, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Százhalombatta, Hungary
        • Research Site
  • Ukraine
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1
Placebo dose
Drug: Placebo
Oral dose bid
Experimental: 2
Treatment arm AZD5069 50mg
Drug: AZD5069 50mg
Oral dose bid
Experimental: 3
Treatment arm AZD5069 80mg
Drug: AZD5069 80mg
Oral dose bid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Conditions

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