The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Research Site
Hvidovre, Denmark
Research Site
København NV, Denmark
Research Site
Odense C, Denmark
Research Site
Helsinki, Finland
Number of Patients Experiencing Adverse Events
Number of patients who had an Adverse Event
Time frame: At all study visits
Forced Expiratory Volume 1 (FEV1)
Change in (FEV1) from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Inspiratory Capacity (IC)
Change from IC baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Expiratory Flow (FEF) 25%-75%
Change in FEF from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Change from average during run-in to average during treatment
Time frame: Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during treatment
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Research Site
Preitilä, Finland
Research Site
Tampere, Finland
Research Site
Breda, Netherlands
Research Site
Groningen, Netherlands
Research Site
Elverum, Norway
Research Site
Oslo, Norway
...and 2 more locations
Time frame: Daily during run-in and treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time frame: Daily during run-in and treatment
6-minute Walk Test
Change from baseline to end of treatment
Time frame: Before treatment and after 4 weeks of treatment