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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD9668
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire, Computed Tomography, MSCT

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD9668

Placebo

Arm Description

Outcomes

Primary Outcome Measures

AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.

Secondary Outcome Measures

5th Generation Wall Area Percentage
5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Air Trapping Index (ATI) on Expiratory Scans
ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Pre-bronchodilator Inspiratory Capacity (IC)
Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Total Lung Capacity (TLC)
Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Functional Residual Capacity (FRC)
Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Residual Volume (RV)
Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Specific Airway Conductance (SGaw)
Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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).
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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).
Pre-bronchodilator Forced Vital Capacity (FVC)
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).
Post-bronchodilator Forced Vital Capacity (FVC)
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).
Pre-bronchodilator Slow Vital Capacity (SVC)
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).
Post-bronchodilator Slow Vital Capacity (SVC)
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).
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
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).
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
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).
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
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)).
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Percentage of reliever free days in last 6 weeks on treatment.
Exacerbations
Number of patients experiencing disease exacerbations on treatment.

Full Information

First Posted
January 20, 2010
Last Updated
August 14, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01054170
Brief Title
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire, Computed Tomography, MSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD9668
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Primary Outcome Measure Information:
Title
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
Description
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Secondary Outcome Measure Information:
Title
5th Generation Wall Area Percentage
Description
5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Air Trapping Index (ATI) on Expiratory Scans
Description
ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Inspiratory Capacity (IC)
Description
Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Total Lung Capacity (TLC)
Description
Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Functional Residual Capacity (FRC)
Description
Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Residual Volume (RV)
Description
Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Specific Airway Conductance (SGaw)
Description
Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Description
Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Forced Vital Capacity (FVC)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Post-bronchodilator Forced Vital Capacity (FVC)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Pre-bronchodilator Slow Vital Capacity (SVC)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Post-bronchodilator Slow Vital Capacity (SVC)
Description
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).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Description
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Description
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Description
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).
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
Description
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).
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
Description
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)).
Time Frame
Measured after 12 weeks treatment (day 84)
Title
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Description
Percentage of reliever free days in last 6 weeks on treatment.
Time Frame
Average from measurements recorded daily by patient in last 6 weeks of treatment.
Title
Exacerbations
Description
Number of patients experiencing disease exacerbations on treatment.
Time Frame
Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Asger Dirksen
Organizational Affiliation
Gentofte Hospital, Department of Lung Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Odensec
Country
Denmark
Facility Name
Research Site
City
Breda
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
26043724
Citation
Nordenmark LH, Taylor R, Jorup C. Feasibility of Computed Tomography in a Multicenter COPD Trial: A Study of the Effect of AZD9668 on Structural Airway Changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5.
Results Reference
derived

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

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