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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
Laymen Terminology Chronic Bronchitis and Emphysema
Keywords: Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Patients Who Experienced at Least One Adverse Events(s)
timeFrame: From start of treatment (Day 0) up to 28 days (End of Treatment)
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Last Observation on Treatment (up to Day 28)
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for Body Temperature
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
measure: Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)
timeFrame: Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])
measure: Change From Baseline to End of Treatment for Total Protein (Urinalysis)
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)
Secondary outcomes:
measure: Plasma Concentration of AZD5069 After 1 Hour of Dosing
timeFrame: End of Treatment (Day 28), 1 hour after dosing
measure: Area Under the Plasma Concentration Curve of AZD5069
timeFrame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
measure: Maximum Plasma Concentration for AZD5069
timeFrame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
measure: Time to Maximum Plasma Concentration for AZD5069
timeFrame: End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing
measure: Maximum Reduction of Circulating Neutrophils in Blood, From Baseline
timeFrame: Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: GROßHANSDORF
country: Germany
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Százhalombatta
country: Hungary
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
Study officials:
References:
citation: Kirsten AM, Forster K, Radeczky E, Linnhoff A, Balint B, Watz H, Wray H, Salkeld L, Cullberg M, Larsson B. The safety and tolerability of oral AZD5069, a selective CXCR2 antagonist, in patients with moderate-to-severe COPD. Pulm Pharmacol Ther. 2015 Apr;31:36-41. doi: 10.1016/j.pupt.2015.02.001. Epub 2015 Feb 11.