The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Medical University of Lodz, Department of Pneumonology and Allergy
Lodz, Poland
Heart rate
Difference in mean heart rate during ivabradine and placebo treatment
Time frame: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)
Peak expiratory flow rate (PEFR)
Difference in mean daily PEFR during ivabradine and placebo treatment
Time frame: Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
Symptoms
Difference in mean daily symptom score between ivabradine and placebo treatment
Time frame: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
Rescue medication
Difference in mean daily rescue medication use between ivabradine and placebo treatment
Time frame: Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
Number of participants with adverse events (AEs)
Difference in number of participants with AEs between ivabradine and placebo treatment
Time frame: Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)
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