The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
56
60 mg, oral tablet, twice daily for 28 days
Match placebo to 60 mg, oral tablet, twice daily for 28 days
Research Site
Copenhagen, Denmark
Research Site
Hamburg, Germany
Research Site
Kiel, Germany
Research Site
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
Time frame: Baseline and Values from day 21 to 28
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)
Time frame: Baseline and Values from day 21 to 28
24-hour Sputum Weight
Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.
Time frame: Baseline and day 28
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.
Time frame: Baseline and day 28
Slow Vital Capacity (SVC)
Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.
Time frame: Baseline and day 28
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.
Time frame: Baseline and day 28
Forced Vital Capacity (FVC)
Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.
Time frame: Baseline and day 28
Morning Peak Expiratory Flow (PEF)
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Leipzig, Germany
Research Site
München, Germany
Research Site
Rabka-Zdrój, Poland
Research Site
Warsaw, Poland
Research Site
Moscow, Russia
Research Site
Gothenburg, Sweden
Research Site
Lund, Sweden
...and 4 more locations
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
Time frame: Last 7 days on treatment
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
Time frame: The last 7 days on treatment
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.
Time frame: The last 7 days on treatment
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.
Time frame: Baseline and day 28
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
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
Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline
Ratio of day 28 to baseline
Time frame: Baseline and day 28
Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline
Ratio of day 28 to baseline
Time frame: Baseline and day 28