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

NCT01365286 | Completed Phase 4 DMC

• 1 other identifier: Ivabradine2009-2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Keywords

asthma, chronic obstructive pulmonary disease, COPD, ivabradine, heart rate

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Difference in mean heart rate during ivabradine and placebo treatment

  Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)

Secondary Outcomes (4)

• Peak expiratory flow rate (PEFR)

  Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment

• Symptoms

  Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment

• Rescue medication

  Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment

• Number of participants with adverse events (AEs)

  Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment)

Study Arms (2)

Ivabradine-Placebo

ACTIVE COMPARATOR

Drug: Ivabradine (Procoralan)

Placebo-Ivabradine

ACTIVE COMPARATOR

Drug: Placebo

Interventions

Ivabradine (Procoralan) DRUG

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

Ivabradine-Placebo

Placebo DRUG

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

Placebo-Ivabradine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• disease exacerbation in previous month
• inability to understand instructions on study procedures

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz, Department of Pneumonology and Allergy

Lodz, 90-153, Poland

Location

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MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 12, 2012

Record last verified: 2011-05

Locations

PL (1)