AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)

October 17, 2014 updated by: AstraZeneca

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

The purpose of the study is to investigate the tolerability and safety of AZD2423 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.
63

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
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Zilina, Slovakia
        • 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:

  • 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.

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: Basic Science
  • 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.
Experimental: AZD2423
AZD2423 Oral Treatment for 28 days
Drug: AZD2423
100 mg oral treatment once daily for 28 days
Placebo Comparator: Placebo
Oral treatment for 28 days
Drug: Placebo to AZD2423
Oral treatment once daily for 28 days

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
Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
Time Frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in vital signs assessed at all the listed time points
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in ECG Variables
Time Frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in ECG variables assessed at all the listed time points
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in Physical Examination
Time Frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in physical examination assessed at all the listed time points
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Monocytes at Baseline
Time Frame: Day 1
Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)
Day 1
Monocytes at End of Treatment
Time Frame: week 4
Monocyte count in peripheral blood at end of treatment (4 weeks)
week 4
Monocytes at Follow-up
Time Frame: week 5 (follow-up)
Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)
week 5 (follow-up)

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
Morning FEV1 at Baseline
Time Frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning FEV1 During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Average of the last 7 days of treatment (week 4)
Evening FEV1 at Baseline
Time Frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Measurement conducted by patient in evening.
Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening FEV1 During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
Measurement conducted by patient in evening.
Average of the last 7 days of treatment (week 4)
Morning Peak Expiratory Flow (PEF) at Baseline
Time Frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning PEF During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Average of the last 7 days of treatment (week 4)
Evening PEF at Baseline
Time Frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Measurement conducted by patient in evening.
Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening PEF During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
Measurement conducted by patient in evening.
Average of the last 7 days of treatment (week 4)
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline
Time Frame: Average of 7 days of pre-treatment measurements (day -7 to -1)
The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.
Average of 7 days of pre-treatment measurements (day -7 to -1)
EXACT Total Score During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).
Average of the last 7 days of treatment (week 4)
Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline
Time Frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.
Average of 10 days of pre-treatment measurements (day -10 to -1)
BCSS (Evening) Total Score During Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.
Average of the last 7 days of treatment (week 4)
Rescue Medication Use During the Last 7 Days of Treatment
Time Frame: Average of the last 7 days of treatment (week 4)
Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.
Average of the last 7 days of treatment (week 4)
St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline
Time Frame: Day 1
The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.
Day 1
SGRQ Total Score at End of Treatment
Time Frame: week 4
Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.
week 4
CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline
Time Frame: Day 1
Baseline = Day 1 = Visit 2
Day 1
CCL2 Concentration in Plasma at End of Treatment
Time Frame: week 4
End of treatment = 4 weeks = Visit 6
week 4
Serum Amyloid-A (SAA) Concentration in Plasma at Baseline
Time Frame: Day 1
Baseline = Day 1 = Visit 2
Day 1
SAA Concentration in Plasma at End of Treatment
Time Frame: week 4
End of treatment = 4 weeks = Visit 6
week 4
Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time Frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state
2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time Frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state
2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time Frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state
2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time Frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state
2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joanna Marks-Konczalik, MD, PhD, AstraZeneca R&D

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.

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.
October 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).
September 30, 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.
October 5, 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.
October 6, 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.
October 23, 2014

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.
October 17, 2014

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.
October 1, 2014

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.
  • D3320C00002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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