Clinical trial NCT01365286: HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
Official title: Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Keywords: asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate
timeFrame: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)
Secondary outcomes:
measure: Peak expiratory flow rate (PEFR)
timeFrame: Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
measure: Symptoms
timeFrame: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
measure: Rescue medication
timeFrame: Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
measure: Number of participants with adverse events (AEs)
timeFrame: Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz, Department of Pneumonology and Allergy
Study officials:
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