14729-D9831C00002- 1 Month Biopsy Study (Biopsy)

January 27, 2014 updated by: AstraZeneca

A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 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.
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

  • Germany
      • Frieburg, Germany
        • Research Site
      • GROßHANSDORF, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
  • United Kingdom
      • Leicester, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle upon Tyne, United Kingdom
        • 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:

  • Men or women 40 years or above
  • FEV1 between 40 and 80% of predicted normal value post-bronchodilator
  • Clinical diagnosis of COPD

Exclusion Criteria:

  • Other clinically relevant disease or disorders
  • Exacerbation of COPD within 30 days

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
Placebo
Experimental: AZD1981
Drug: AZD1981
Oral tablet, twice daily, 4 weeks treatment

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
Aggregated Pathology Score
Time Frame: Before and after 1 month treatment
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Total Cells Count
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Before and after 1 month treatment
Induced Sputum: Eosinophil Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Eosinophil count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Neutrophils Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Neutrophils count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Macrophages Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Macrophages count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Lymphocytes Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Lymphocytes count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Epithelial Cells Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Epithelial cells count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Total Cells Count
Time Frame: Before and after 3 week treatment
Change in Induced sputum Total cells count from baseline
Before and after 3 week treatment

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
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Before and after 1 month treatment
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
Before and after 1 month treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Time Frame: Before and after 1 month treatment
Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
Before and after 1 month treatment
Peak Expiratory Flow (PEF) Morning
Time Frame: Before and after 1 month treatment
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Before and after 1 month treatment
Peak Expiratory Flow (PEF) Evening
Time Frame: Before and after 1 month treatment
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Time Frame: Before and after 1 month treatment
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)
Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Time Frame: Before and after 1 month treatment
Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).
Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Time Frame: Before and after 1 month treatment
Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)
Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Time Frame: Before and after 1 month treatment
Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Before and after 1 month treatment
Adverse Event (AE)
Time Frame: 1 month
Number of participants with an Adverse Event
1 month

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: Norbert Krug, Fraunhofer Institute

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.
November 1, 2008

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.
June 1, 2009

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).
October 3, 2008

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 3, 2008

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, 2008

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.
February 28, 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.
January 27, 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.
January 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.
  • D9831C00002

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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