Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium bromide as delivered by the RESPIMAT® device when administered over a two-week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring
Time frame: Pre-treatment, on Day 7 and 13
Number of patients with adverse events
Time frame: Up to 15 days after first drug administration
Number of patients with clinical significant findings in ECG
Time frame: Up to 15 days after first drug administration
Number of patients with clinical significant findings in vital signs
Time frame: Up to 15 days after first drug administration
Number of patients with clinical significant findings in laboratory tests
Time frame: Up to day 15 after drug administration
Number of patients with paradoxical bronchospasm
Time frame: Up to 15 days after first drug administration
FEV1 (forced expiratory volume in the first second) AUC0-4 (Area under the curve from 0 to 4 hours)
Time frame: Pre-treatment, up to 4 h after drug administration on Day 1 and 14
Peak FEV1
Time frame: On Day 1 and 14
Onset of therapeutic FEV1 response
Time frame: On Day 1 and 14
Time to peak FEV1 response
Time frame: On Day 1 and 14
AUC(0-6h) (Area under the plasma concentration-time curve from 0 to 6 h)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 14
Cmax (maximum plasma concentration)
Time frame: Day 14
Cmin(0h) (minimum plasma concentration before inhalation)
Time frame: Day 14
Cmin(6h) (minimum plasma concentration at 6 hours after inhalation)
Time frame: Day 14
Ae(0-2h) (urine excretion between 0 to 2 h)
Time frame: Day 14
Ae(0-6h) (urine excretion between 0 to 6 h)
Time frame: Day 14