Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

August 14, 2012 updated by: AstraZeneca

A 12-week, Phase II, Double-blind, Placebo-Controlled, Randomised, Parallel-Group, Multi-Centre Study to Assess the Effect of 60mg AZD9668 Administered Orally Twice Daily on Structural Changes in the Airways by Multi-Slice Computed Tomography in Patients With Chronic Obstructive Pulmonary Disease.

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

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.
52

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

  • Canada
      • Quebec, Canada
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada
        • Research Site
  • Denmark
      • Hellerup, Denmark
        • Research Site
      • Hvidovre, Denmark
        • Research Site
      • Odensec, Denmark
        • Research Site
  • Netherlands
      • Breda, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
  • Romania
      • Bucuresti, Romania
        • Research Site
  • Ukraine
      • Kyiv, Ukraine
        • 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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COPD with symptoms over 1 year
  • FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
  • Ex-smokers for at least 12 months

Exclusion Criteria:

  • Past history or current evidence of clinically significant heart disease
  • Current diagnosis of asthma
  • Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Placebo Comparator: Placebo
Drug: Placebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Experimental: AZD9668
Drug: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks

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
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
Time Frame: Measured after 12 weeks treatment (day 84)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)

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
5th Generation Wall Area Percentage
Time Frame: Measured after 12 weeks treatment (day 84)
5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Air Trapping Index (ATI) on Expiratory Scans
Time Frame: Measured after 12 weeks treatment (day 84)
ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Inspiratory Capacity (IC)
Time Frame: Measured after 12 weeks treatment (day 84)
Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Total Lung Capacity (TLC)
Time Frame: Measured after 12 weeks treatment (day 84)
Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Functional Residual Capacity (FRC)
Time Frame: Measured after 12 weeks treatment (day 84)
Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Residual Volume (RV)
Time Frame: Measured after 12 weeks treatment (day 84)
Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Specific Airway Conductance (SGaw)
Time Frame: Measured after 12 weeks treatment (day 84)
Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Time Frame: Measured after 12 weeks treatment (day 84)
Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Measured after 12 weeks treatment (day 84)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Measured after 12 weeks treatment (day 84)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Vital Capacity (FVC)
Time Frame: Measured after 12 weeks treatment (day 84)
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Vital Capacity (FVC)
Time Frame: Measured after 12 weeks treatment (day 84)
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Slow Vital Capacity (SVC)
Time Frame: Measured after 12 weeks treatment (day 84)
Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Post-bronchodilator Slow Vital Capacity (SVC)
Time Frame: Measured after 12 weeks treatment (day 84)
Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured after 12 weeks treatment (day 84)
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).
Average from measurements recorded daily by patient in last 6 weeks of treatment.
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).
Average from measurements recorded daily by patient in last 6 weeks of treatment.
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
Time Frame: Measured after 12 weeks treatment (day 84)
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Measured after 12 weeks treatment (day 84)
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Percentage of reliever free days in last 6 weeks on treatment.
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Exacerbations
Time Frame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)
Number of patients experiencing disease exacerbations on treatment.
Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)

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.
  • Principal Investigator: Professor Asger Dirksen, Gentofte Hospital, Department of Lung Medicine

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.

General Publications

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.
January 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.
November 1, 2010

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.
November 1, 2010

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).
January 20, 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.
January 21, 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.
January 22, 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.
August 20, 2012

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.
August 14, 2012

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.
August 1, 2012

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.
  • D0520C00014

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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