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Completed

NCT Number: NCT01233232

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

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

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Key information

Conditions

Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Emphysema Laymen Terminology Chronic Bronchitis and Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Oral dose bid

AZD5069 50mg

Drug

Oral dose bid

AZD5069 80mg

Drug

Oral dose bid

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: CIRRUS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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