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

AstraZeneca52 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

AZD9668DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (9)

Research Site

Kingston, Ontario, Canada

Research Site

Québec, Quebec, Canada

Research Site

Hellerup, Denmark

Research Site

Hvidovre, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Measured after 12 weeks treatment (day 84)

Secondary Outcomes

5th Generation Wall Area Percentage

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)

Air Trapping Index (ATI) on Expiratory Scans

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)

Pre-bronchodilator Inspiratory Capacity (IC)

Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.

Time frame: Measured after 12 weeks treatment (day 84)

Pre-bronchodilator Total Lung Capacity (TLC)

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)

Pre-bronchodilator Functional Residual Capacity (FRC)

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)

Pre-bronchodilator Residual Volume (RV)

Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.

Data from ClinicalTrials.gov

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Research Site

Odensec, Denmark

Research Site

Breda, Netherlands

Research Site

Nieuwegein, Netherlands

Research Site

Bucharest, Romania

Research Site

Kyiv, Ukraine

Time frame: Measured after 12 weeks treatment (day 84)

Pre-bronchodilator Specific Airway Conductance (SGaw)

Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.

Time frame: Measured after 12 weeks treatment (day 84)

Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)

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)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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).

Time frame: Measured after 12 weeks treatment (day 84)

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.

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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 .

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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.

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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.

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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).

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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).

Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.

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)).

Time frame: Measured after 12 weeks treatment (day 84)

Percentage of Reliever Free Days in Last Six Weeks of Treatment

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.

Exacerbations

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)