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

Phase 4

Completed

• Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Placebo; Drug: Ivabradine (Procoralan)

• Registration Number: NCT01365286
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• disease exacerbation in previous month
• inability to understand instructions on study procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo-Ivabradine	Placebo	-
Ivabradine-Placebo	Ivabradine (Procoralan)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Lodz, Department of Pneumonology and Allergy; 🇵🇱 Lodz, Poland