HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
NCT ID: NCT01365286
Last Updated: 2012-06-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-05-31
Study Completion Date
2011-01-31
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.
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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.
Conditions
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Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Ivabradine-Placebo
Group Type
ACTIVE_COMPARATOR
Ivabradine (Procoralan)
Intervention Type
DRUG
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
Placebo-Ivabradine
Group Type
ACTIVE_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Interventions
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Ivabradine (Procoralan)
Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
Intervention Type
DRUG
Placebo
Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
Intervention Type
DRUG
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
* 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
* inability to understand instructions on study procedures
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical University of Lodz
OTHER
Sponsor Role
lead
Responsible Party
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Medical University of Lodz, Department of Pneumonology and Allergy
Locations
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Medical University of Lodz, Department of Pneumonology and Allergy
Lodz, , Poland
Site Status
Countries
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Poland
References
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BACKGROUND
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Reference Type
DERIVED
Other Identifiers
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Ivabradine2009-2011
Identifier Type: -
Identifier Source: org_study_id
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