HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Ivabradine (Procoralan)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivabradine-Placebo<br> | Drug: Ivabradine (Procoralan)<br>* Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)<br>|
| Active Comparator: Placebo-Ivabradine<br> | Drug: Placebo<br>* Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Difference in mean heart rate during ivabradine and placebo treatment | Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow rate (PEFR) | Difference in mean daily PEFR during ivabradine and placebo treatment | 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 | 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 | 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 | Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate