This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
AZD8683 administered via inhalation
Placebo administered via inhalation
Tiotropium administered via inhalation
Unnamed facility
Bialystok, Poland
Unnamed facility
Lodz, Poland
Unnamed facility
Proszowice, Poland
Unnamed facility
Wroclaw, Poland
Unnamed facility
Gothenburg, Sweden
Change From Baseline in Peak FEV1 (0-24h)
The maximum value over 24 hours post-dose, as change from baseline
Time frame: The first 24 hours following dose administration
Change From Baseline in Trough FEV1 (22-26h)
The average over 22 to 26 hours, as change from baseline
Time frame: 22 to 26 hours following dose administration
Average FEV1 as a Change From Baseline
Average FEV1 (0-24h): The average over 0 to 24 hours
Time frame: The first 24 hours following dose administration
Maximum Increase in Systolic Blood Pressure [SBP]
Maximum (post-dose values - baseline value) for each treatment visit.
Time frame: baseline, 24hr post dose
Maximum Increase in Diastolic Blood Pressure [DBP]
Maximum (post-dose values - baseline value) for each treatment visit.
Time frame: The first 24 hours following dose administration
Maximum Increase Heart Rate [HR]
Maximum (post-dose values - baseline value) for each treatment visit.
Time frame: baseline, 24hr post dose
Maximum Increase in QTcF
maximum (post-dose values - baseline value) for each treatment visit.
Time frame: baseline, 24hr post dose
PK Parameters (AZD8683)
Cmax, tmax, AUC
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Unnamed facility
Lund, Sweden
Time frame: Pre-dose, 24hr post-dose