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Completed

NCT Number: NCT01365286

HR-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.

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Key information

Conditions

Asthma, Chronic Obstructive Pulmonary Disease (COPD) Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Lodz, Department of Pneumonology and Allergy

Lodz, 90-153, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivabradine (Procoralan)

Drug

Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)

Placebo

Drug

Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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