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Completed

NCT Number: NCT01054170

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

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)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9668

Drug

2 x 30 mg oral tablets twice daily (bid) for 12 weeks

Placebo

Drug

2 x matched placebo to oral tablet twice daily (bid) for 12 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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.

  16. 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 .

  17. 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.

  18. 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.

  19. 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).

  20. 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).

  21. 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)).

  22. 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.

  23. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2010
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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