The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) 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
38
Research Site
Chemin Sainte-Foy, Quebec, Canada
Research Site
Calgary, Canada
Research Site
Montreal, Canada
Research Site
Ontario, Canada
Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
24-hour Sputum Weight(g)
Sputum weight (g) collected during 24 hour periods.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 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
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
Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)
FEF25-75% 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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Research Site
Vancouver, Canada
Research Site
Birmingham, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
London, United Kingdom
Research Site
Newcastle, United Kingdom
Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean 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 mean baseline value to mean of the last 7 days on treatment
Time frame: 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: Last 7 days on treatment
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.
Time frame: Baseline and day 28
Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 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