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

Medical University of Lodz

Status and phase: Completed; Phase 4

Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Ivabradine (Procoralan); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01365286

Ivabradine2009-2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Ivabradine-Placebo

Active Comparator group

Treatment:

Drug: Ivabradine (Procoralan)

Placebo-Ivabradine

Active Comparator group

Treatment:

Drug: Placebo