Back to resultsHR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
Primary Purpose
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ivabradine (Procoralan)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma, Chronic Obstructive Pulmonary Disease (COPD) focused on measuring asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
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
Sites / Locations
- Medical University of Lodz, Department of Pneumonology and Allergy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ivabradine-Placebo
Placebo-Ivabradine
Arm Description
Outcomes
Primary Outcome Measures
Heart rate
Difference in mean heart rate during ivabradine and placebo treatment
Secondary Outcome Measures
Peak expiratory flow rate (PEFR)
Difference in mean daily PEFR during ivabradine and placebo treatment
Symptoms
Difference in mean daily symptom score between ivabradine and placebo treatment
Rescue medication
Difference in mean daily rescue medication use between ivabradine and placebo treatment
Number of participants with adverse events (AEs)
Difference in number of participants with AEs between ivabradine and placebo treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365286
Brief Title
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
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Lodz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Keywords
asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivabradine-Placebo
Arm Type
Active Comparator
Arm Title
Placebo-Ivabradine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ivabradine (Procoralan)
Intervention Description
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Primary Outcome Measure Information:
Title
Heart rate
Description
Difference in mean heart rate during ivabradine and placebo treatment
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)
Secondary Outcome Measure Information:
Title
Peak expiratory flow rate (PEFR)
Description
Difference in mean daily PEFR during ivabradine and placebo treatment
Time Frame
Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment
Title
Symptoms
Description
Difference in mean daily symptom score between ivabradine and placebo treatment
Time Frame
Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment
Title
Rescue medication
Description
Difference in mean daily rescue medication use between ivabradine and placebo treatment
Time Frame
Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment
Title
Number of participants with adverse events (AEs)
Description
Difference in number of participants with AEs between ivabradine and placebo treatment
Time Frame
Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical University of Lodz, Department of Pneumonology and Allergy
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
12. IPD Sharing Statement
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HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
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