| Primary | Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | Baseline and Values from day 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG0001.07(0.82 to 1.40)
- OG0011.10(0.86 to 1.41)
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|
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| Primary | Sputum Percentage Neutrophil Count | Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the 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 neutrophils in WBCs | | Baseline and Values from day 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | 24-hour Sputum Weight | Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28. | 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 | grams | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Forced Expiratory Volume in 1 Second (FEV1) | Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28. | 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 | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Slow Vital Capacity (SVC) | Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28. | 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 | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) | FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28. | 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 | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Forced Vital Capacity (FVC) | Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28. | 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 | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Morning Peak Expiratory Flow (PEF) | Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days 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 | L/min | | Last 7 days on treatment | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Evening Peak Expiratory Flow (PEF) | Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days 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 | L/min | | The last 7 days on treatment | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Bronkotest Diary Card Signs and Symptoms | The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported. | 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 | | Signs and Symptoms | | The last 7 days on treatment | | | | ID | Title | Description |
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| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Primary | Cystic Fibrosis Questionnaire (CFQ-R) - Quittner | Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28. | 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 | units on a scale | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Secondary | Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Secondary | Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Secondary | Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| |
| Secondary | Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| |
| Secondary | Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| |
| Secondary | Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Secondary | Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline | Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits | 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 | 95% Confidence Interval | ratio | | End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| |
| Secondary | Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline | Ratio of day 28 to baseline | 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 | 95% Confidence Interval | ratio | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
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| Secondary | Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline | Ratio of day 28 to baseline | 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 | 95% Confidence Interval | ratio | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | AZD9668 | AZD9668, 2 x 30 mg twice daily (bid) | | OG001 | Placebo | Placebo, 2 tablets twice daily (bid) |
| |