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

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: AZD9668
Drug: Placebo

Registration Number: NCT01054170

Lead Sponsor: AstraZeneca

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD9668	AZD9668	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)	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 Outcome Measures

Name	Time	Method
5th Generation Wall Area Percentage	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.
Air Trapping Index (ATI) on Expiratory Scans	Measured after 12 weeks treatment (day 84)	ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Pre-bronchodilator Inspiratory Capacity (IC)	Measured after 12 weeks treatment (day 84)	Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Total Lung Capacity (TLC)	Measured after 12 weeks treatment (day 84)	Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Functional Residual Capacity (FRC)	Measured after 12 weeks treatment (day 84)	Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Residual Volume (RV)	Measured after 12 weeks treatment (day 84)	Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Specific Airway Conductance (SGaw)	Measured after 12 weeks treatment (day 84)	Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)	Measured after 12 weeks treatment (day 84)	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)	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).
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	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).
Pre-bronchodilator Forced Vital Capacity (FVC)	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).
Post-bronchodilator Forced Vital Capacity (FVC)	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).
Pre-bronchodilator Slow Vital Capacity (SVC)	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).
Post-bronchodilator Slow Vital Capacity (SVC)	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).
Peak Expiratory Flow (PEF) Morning (Daily Recordings)	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.
Peak Expiratory Flow (PEF) Evening (Daily Recordings)	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 .
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)	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.
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)	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.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score	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).
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score	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).
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score	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)).
Percentage of Reliever Free Days in Last Six Weeks of Treatment	Average from measurements recorded daily by patient in last 6 weeks of treatment.	Percentage of reliever free days in last 6 weeks on treatment.
Exacerbations	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.