| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | mm | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.84± 0.021(0.021 to )
- OG0013.83± 0.017(0.017 to )
|
|
| |
| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | Percentage Area | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Air Trapping Index (ATI) on Expiratory Scans | ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | ATI Percentage | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Pre-bronchodilator Inspiratory Capacity (IC) | Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Pre-bronchodilator Total Lung Capacity (TLC) | Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Pre-bronchodilator Functional Residual Capacity (FRC) | Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Pre-bronchodilator Residual Volume (RV) | Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Pre-bronchodilator Specific Airway Conductance (SGaw) | Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | 1/[s*kPa] | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | mmol/kPa*min | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L/min | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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 . | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L/min | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | L | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | Total Score | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | Total Score | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| 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)). | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Measured after 12 weeks treatment (day 84) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Percentage of Reliever Free Days in Last Six Weeks of Treatment | Percentage of reliever free days in last 6 weeks on treatment. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Least Squares Mean | Standard Error | percentage of days | | Average from measurements recorded daily by patient in last 6 weeks of treatment. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |
| Secondary | Exacerbations | Number of patients experiencing disease exacerbations on treatment. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | Posted | | Number | | Participants | | Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up) | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | | | OG001 | Placebo | |
| |