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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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)

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

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

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

Research Site

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.

AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.

5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.

ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.

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

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

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

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

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

Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.

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).

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).

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).

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).

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).

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 (L/min) as a measure of lung function, measured at home by the patient each morning.

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 (L) as a measure of lung function, measured at home by the patient each morning.

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, 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, 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 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 6 weeks on treatment.

Number of patients experiencing disease exacerbations on treatment.

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

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

Official Title

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Documents available

CSR-D0520C00014.pdf

Redacted Protocol

Trial Results Summaries

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