Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Solution for inhalation through nebulization, single dose
Dry powder for inhalation, single dose
Placebo
Research Site
Gothenburg, Sweden
Research Site
Luleå, Sweden
Research Site
Lund, Sweden
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
Maximum FEV1 value
Time frame: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
Trough FEV1 value
Time frame: 22 h, 24 h, 26 h
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
Average FEV1 value
Time frame: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
15 min FEV1 value
Time frame: 15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Average systolic blood pressure value
Time frame: 0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Average diastolic blood pressure value
Time frame: 0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose
Average pulse value
Time frame: 0, 30 min, 2 h, 4 h
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
Average heart rate value
Time frame: 0, 30 min, 2 h, 4 h
QTcF, Average Effect Over 0 - 4 Hours Post-dose
Average QTcF value
Time frame: 0, 30 min, 2 h, 4 h
Plasma AZD9164 Cmax
Maximum plasma concentration of AZD9164
Time frame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD9164 AUC0-24
Area under the AZD9164 plasma concentration curve
Time frame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
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