Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

March 23, 2015 updated by: AstraZeneca

A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

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.
71

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

  • Germany
      • Hannover, Germany
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
  • ≥ 40 years of age at Visit 1
  • Clinical diagnosis of COPD (GOLD stage 1)
  • FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
  • FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
  • Any clinically relevant 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 or take part or influence the results of the study
  • A past history or current indication of renal (kidney) failure
  • Subjects at risk of active tuberculosis or of disease reactivation
  • Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

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: Double

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: 1
Oral treatment
Drug: AZD2423
100mg Oral dose od
Placebo Comparator: 2
Oral treatment
Drug: AZD2423 Placebo
Oral dose od

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
Absolute Monocyte Count in BAL Post-LPS Challenge
Time Frame: Day 11
Monocyte count in BAL post-LPS challenge (Day 11)
Day 11

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
Total Neutrophils in Biopsy Sample (Post-LPS Challenge)
Time Frame: Day 11
Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.
Day 11
Total Macrophages in Biopsy Sample (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Day 11
CD45+ in Biopsy Sample (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Day 11
CD3+ in Biopsy Sample (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Day 11
Biopsy PAS Reaction Grade (Post-LPS Challenge)
Time Frame: Day 11
Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).
Day 11
Biopsy Epithelium Grade (Post-LPS Challenge)
Time Frame: Day 11
Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells
Day 11
Eosinophils in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Day 11
Lymphocytes in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Day 11
Neutrophils in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Day 11
Macrophages in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Day 11
TNF α Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
CCL2 Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
IL-1β Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
IL-6 Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
IL-8 Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
RANTES Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
SP-D Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11
SAA Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
SAA concentration in blood pre-LPS challenge (Day 10).
Day 10
SAA Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
SAA concentration in blood post-LPS challenge (Day 11)
Day 11
CCL2 Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
CCL2 concentration in blood pre-LPS challenge (Day 10)
Day 10
CCL2 Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
CCL2 concentration in blood post-LPS challenge (Day 11).
Day 11
IL-1β Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
IL-1β concentration in blood pre-LPS challenge (Day 10)
Day 10
IL-1β Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
IL-1β concentration in blood post-LPS challenge (Day 11)
Day 11
IL-6 Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
IL-6 concentration in blood pre-LPS challenge (Day 10)
Day 10
IL-6 Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
IL-6 concentration in blood post-LPS challenge (Day 11)
Day 11
IL-8 Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
IL-8 concentration in blood pre-LPS challenge (Day 10)
Day 10
IL-8 Concentration in Blood (Post-LPS Challenge)
Time Frame: day 11
IL-8 concentration in blood post-LPS challenge (Day 11)
day 11
TNF-α Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
TNF-α concentration in blood pre-LPS challenge (Day 10)
Day 10
TNF-α Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
TNF-α concentration in blood post-LPS challenge (Day 11)
Day 11
SP-D Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
SP-D concentration in blood pre-LPS challenge (Day 10)
Day 10
SP-D Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
SP-D concentration in blood post-LPS challenge (Day 11)
Day 11
CC16 Concentration in Blood (Pre-LPS Challenge)
Time Frame: Day 10
CC16 concentration in blood pre-LPS challenge (Day 10)
Day 10
CC16 Concentration in Blood (Post-LPS Challenge)
Time Frame: Day 11
CC16 concentration in blood post-LPS challenge (Day 11)
Day 11
Basophils in Blood (Pre-LPS Challenge)
Time Frame: day 10
Basophils in blood pre-LPS challenge (Day 10)
day 10
Basophils in Blood (Post-LPS Challenge)
Time Frame: Day 11
Basophils in blood post-LPS challenge (Day 11)
Day 11
Eosinophils in Blood (Pre-LPS Challenge)
Time Frame: Day 10
Eosinophils in blood pre-LPS challenge (Day 10)
Day 10
Eosinophils in Blood (Post-LPS Challenge)
Time Frame: Day 11
Eosinophils in blood post-LPS challenge (Day 11)
Day 11
Lymphocytes in Blood (Pre-LPS Challenge)
Time Frame: Day 10
Lymphocytes in blood pre-LPS challenge (Day 10)
Day 10
Lymphocytes in Blood (Post-LPS Challenge)
Time Frame: Day 11
Lymphocytes in blood post-LPS challenge (Day 11)
Day 11
Monocytes in Blood (Pre-LPS Challenge)
Time Frame: Day 10
Monocytes in blood pre-LPS challenge (Day 10)
Day 10
Monocytes in Blood (Post-LPS Challenge)
Time Frame: Day 11
Monocytes in blood post-LPS challenge (Day 11)
Day 11
Neutrophils in Blood (Pre-LPS Challenge)
Time Frame: Day 10
Neutrophils in blood pre-LPS challenge (Day 10)
Day 10
Neutrophils in Blood (Post-LPS Challenge)
Time Frame: Day 11
Neutrophils in blood post-LPS challenge (Day 11)
Day 11
Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State
Time Frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Steady state pharmacokinetic (PK) profile measured on Day 10
Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Time to Cmax (Tmax) of AZD2423 at Steady State
Time Frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Steady state PK profile measured on Day 10
Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State
Time Frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Steady state PK profile measured on Day 10
Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State
Time Frame: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Steady state PK profile measured on Day 10
Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes
Time Frame: up to 47 days (visit 1 to visit 6)
up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Vital Signs
Time Frame: up to 47 days (visit 1 to visit 6)
up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables
Time Frame: up to 47 days (visit 1 to visit 6)
up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Physical Examination
Time Frame: up to 47 days (visit 1 to visit 6)
up to 47 days (visit 1 to visit 6)
Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)
Time Frame: up to 47 days (visit 1 to visit 6)
up to 47 days (visit 1 to visit 6)
CC16 Concentration in BAL (Post-LPS Challenge)
Time Frame: Day 11
Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Day 11

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: Bengt Larsson, 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.
July 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.
July 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).
June 28, 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.
June 29, 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.
June 30, 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.
April 10, 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.
March 23, 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.
March 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.
  • D3320C00001
  • 2010-020141-26 (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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