Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
Brief summary
The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
Detailed description
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.
Interventions
DRUGIvabradine (Procoralan)
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
DRUGPlacebo
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* documented diagnosis of asthma or COPD in accordance with guidelines * stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment * mean HR in holter ECG recording of ≥ 60 bpm
Exclusion criteria
* disease exacerbation in previous month * inability to understand instructions on study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day) | Difference in mean heart rate during ivabradine and placebo treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak expiratory flow rate (PEFR) | Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment | Difference in mean daily PEFR during ivabradine and placebo treatment |
| Symptoms | Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment | Difference in mean daily symptom score between ivabradine and placebo treatment |
| Rescue medication | Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment | Difference in mean daily rescue medication use between ivabradine and placebo treatment |
| Number of participants with adverse events (AEs) | Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment) | Difference in number of participants with AEs between ivabradine and placebo treatment |
Countries
Poland
Outcome results
None listed