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

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01365286
First received: May 31, 2011
Last updated: June 11, 2012
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Ivabradine (Procoralan)
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    Difference in mean heart rate during ivabradine and placebo treatment


Secondary Outcome Measures:
  • Peak expiratory flow rate (PEFR) [ Time Frame: Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment ] [ Designated as safety issue: Yes ]
    Difference in mean daily PEFR during ivabradine and placebo treatment

  • Symptoms [ Time Frame: Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment ] [ Designated as safety issue: Yes ]
    Difference in mean daily symptom score between ivabradine and placebo treatment

  • Rescue medication [ Time Frame: Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment ] [ Designated as safety issue: Yes ]
    Difference in mean daily rescue medication use between ivabradine and 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) ] [ Designated as safety issue: Yes ]
    Difference in number of participants with AEs between ivabradine and placebo treatment


Enrollment: 40
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365286

Locations
Poland
Medical University of Lodz, Department of Pneumonology and Allergy
Lodz, Poland, 90-153
Sponsors and Collaborators
Medical Universtity of Lodz
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sebastian Majewski, MD, Medical University of Lodz, Department of Pneumonology and Allergy
ClinicalTrials.gov Identifier: NCT01365286     History of Changes
Other Study ID Numbers: Ivabradine2009-2011
Study First Received: May 31, 2011
Last Updated: June 11, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate

Additional relevant MeSH terms:
Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013