The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Helsinki, Finland
Research Site
Incidence of Adverse Events
Number of patients who had an Adverse Event
Time frame: all study visits
Forced Expiratory Volume in 1 Second (FEV1)
Change in FEV1 from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
Inspiratory Capacity (IC)
Change in IC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 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, 4 and 6 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Change in PEF from average during run-in to average during the last 4 w of 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 the last 4 w of treatment
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Oulu, Finland
Research Site
Preitilä, Finland
Research Site
Berlin, Germany
Research Site
Grobhansdorf, Germany
Research Site
Győr, Hungary
Research Site
Komló, Hungary
Research Site
Pécs, Hungary
...and 4 more locations
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) 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, 4 and 6 weeks of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 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 6 weeks of treatment