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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01054170
First received: January 20, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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)


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: AZD9668
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.

  • Pre-bronchodilator Inspiratory Capacity (IC) [ Time Frame: Measured after 12 weeks treatment (day 84)      ] [ Designated as safety issue: No ]
    Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.

  • Pre-bronchodilator Total Lung Capacity (TLC) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.

  • Pre-bronchodilator Functional Residual Capacity (FRC) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.

  • Pre-bronchodilator Residual Volume (RV) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.

  • Pre-bronchodilator Specific Airway Conductance (SGaw) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.

  • Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured after 12 weeks treatment (day 84) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ] [ Designated as safety issue: No ]
    Percentage of reliever free days in last 6 weeks on treatment.

  • Exacerbations [ Time Frame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up) ] [ Designated as safety issue: No ]
    Number of patients experiencing disease exacerbations on treatment.


Enrollment: 52
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9668 Drug: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054170

Locations
Canada, Ontario
Research Site
Kingston, Ontario, Canada
Canada
Research Site
Quebec, Canada
Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Odensec, Denmark
Netherlands
Research Site
Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Romania
Research Site
Bucuresti, Romania
Ukraine
Research Site
Kyiv, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Professor Asger Dirksen Gentofte Hospital, Department of Lung Medicine
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01054170     History of Changes
Other Study ID Numbers: D0520C00014
Study First Received: January 20, 2010
Results First Received: January 24, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
Chronic
obstructive
pulmonary
lung
respiratory disease
efficacy
placebo-controlled
COPD
FEV1
St Georges Respiratory Questionnaire
Computed Tomography
MSCT

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014