Clinical trial NCT01215279: AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Official title: A 4-week, Double-Blind, Placebo-Controlled, Randomised, Parallel Group, Multi-Centre, Phase IIa Study to Investigate the Tolerability and Safety of 100 mg Oral AZD2423 in Patients With Moderate to Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lung Disease
Keywords: Respiratory disease
Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 63
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: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
* Between 40 and 80 years of age at Visit 1
* Clinical diagnosis of COPD (GOLD stage 2 or 3)
* FEV1/FVC \<70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
* Current or ex-smokers

Exclusion Criteria:

* Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
* Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
* Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
* Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
* Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.

Primary outcomes:
measure: Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
timeFrame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
measure: Number of Participants With Clinically Significant Changes in ECG Variables
timeFrame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
measure: Number of Participants With Clinically Significant Changes in Physical Examination
timeFrame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
measure: Monocytes at Baseline
timeFrame: Day 1
measure: Monocytes at End of Treatment
timeFrame: week 4
measure: Monocytes at Follow-up
timeFrame: week 5 (follow-up)
Secondary outcomes:
measure: Morning FEV1 at Baseline
timeFrame: Average of 10 days of pre-treatment measurements (day -10 to -1)
measure: Morning FEV1 During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Evening FEV1 at Baseline
timeFrame: Average of 10 days of pre-treatment measurements (day -10 to -1)
measure: Evening FEV1 During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Morning Peak Expiratory Flow (PEF) at Baseline
timeFrame: Average of 10 days of pre-treatment measurements (day -10 to -1)
measure: Morning PEF During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Evening PEF at Baseline
timeFrame: Average of 10 days of pre-treatment measurements (day -10 to -1)
measure: Evening PEF During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline
timeFrame: Average of 7 days of pre-treatment measurements (day -7 to -1)
measure: EXACT Total Score During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline
timeFrame: Average of 10 days of pre-treatment measurements (day -10 to -1)
measure: BCSS (Evening) Total Score During Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: Rescue Medication Use During the Last 7 Days of Treatment
timeFrame: Average of the last 7 days of treatment (week 4)
measure: St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline
timeFrame: Day 1
measure: SGRQ Total Score at End of Treatment
timeFrame: week 4
measure: CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline
timeFrame: Day 1
measure: CCL2 Concentration in Plasma at End of Treatment
timeFrame: week 4
measure: Serum Amyloid-A (SAA) Concentration in Plasma at Baseline
timeFrame: Day 1
measure: SAA Concentration in Plasma at End of Treatment
timeFrame: week 4
measure: Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State
timeFrame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
measure: Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State
timeFrame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
measure: Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
timeFrame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
measure: Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
timeFrame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Other outcomes:
Locations:
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D
name: Joanna Marks-Konczalik, MD, PhD
role: STUDY_DIRECTOR
References: