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

June 11, 2012 updated by: Medical University of Lodz

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

The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 90-153
        • Medical University of Lodz, Department of Pneumonology and Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
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)
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)
Time Frame: 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
Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
Symptoms
Time Frame: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
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
Time Frame: 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
Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
Number of participants with adverse events (AEs)
Time Frame: 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
Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ivabradine2009-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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