Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
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.
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)
Status | Completed |
Enrollment | 52 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Research Site | Kingston | Ontario |
Canada | Research Site | Quebec | |
Denmark | Research Site | Hellerup | |
Denmark | Research Site | Hvidovre | |
Denmark | Research Site | Odensec | |
Netherlands | Research Site | Breda | |
Netherlands | Research Site | Nieuwegein | |
Romania | Research Site | Bucuresti | |
Ukraine | Research Site | Kyiv |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Canada, Denmark, Netherlands, Romania, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Measured after 12 weeks treatment (day 84) | No |
Secondary | 5th Generation Wall Area Percentage | 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) | No |
Secondary | Air Trapping Index (ATI) on Expiratory Scans | ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Inspiratory Capacity (IC) | Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Total Lung Capacity (TLC) | Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Functional Residual Capacity (FRC) | Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Residual Volume (RV) | Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Specific Airway Conductance (SGaw) | Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) | Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean. | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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). | Measured after 12 weeks treatment (day 84) | No |
Secondary | 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. | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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 . | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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. | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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. | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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). | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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). | Average from measurements recorded daily by patient in last 6 weeks of treatment. | No |
Secondary | 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)). | Measured after 12 weeks treatment (day 84) | No |
Secondary | Percentage of Reliever Free Days in Last Six 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. | No |
Secondary | Exacerbations | 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) | No |
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