Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation

NCT00578968 | Completed Phase 4 Results

• 1 other identifier: 06-003434
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

COPD; Tiotropium; Spiriva

Outcome Measures

Primary Outcomes (4)

• Baseline Resting Cardiac Index (CI)

  Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.

  First visit of first study period

• Baseline Resting Stroke Volume Index (SVI)

  Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m\^2).

  first visit of first study period

• Pretreatment Peak Exercise CI

  Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.

  first visit of first study period

• Pretreatment Peak Exercise SVI

  Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2).

  first visit of first study period

Secondary Outcomes (24)

• Baseline Resting Forced Vital Capacity (FVC)

  First visit of first study period

• Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)

  First visit of first study period

• Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)

  first visit of first study period

• Baseline Resting FEV_1 as Percentage of Predicted FEV_1

  first visit of first study period

• Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups

  first visit of first study period, second visit of first study period

Study Arms (3)

Tiotropium

EXPERIMENTAL

Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.

Drug: Tiotropium

Placebo

PLACEBO COMPARATOR

Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.

Drug: Placebo

Healthy Controls

NO INTERVENTION

Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.

Interventions

Tiotropium DRUG

Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device.

Also known as: Spiriva

Tiotropium

Placebo DRUG

Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.

Placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) \<36
• Moderate to severe COPD patient, (similar to or slightly better than Gold Guidelines Stage 2-3, forced expiratory volume in one second \[FEV\_1\] \<60% of age predicted)
• Smoking history of 10 pack years or more
• Clinical diagnosis of COPD
• Not on daytime oxygen

You may not qualify if:

• Clinical diagnosis of asthma
• Myocardial infarction within the last 6 months, or known ischemia
• Serious uncontrolled cardiac arrhythmia (i.e., atrial fibrillation or ventricular tachycardia) or hospitalization for heart failure within the previous year
• Known moderate to severe renal impairment
• Known moderate to severe symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow angle glaucoma
• Current radiation or chemotherapy for a malignant condition
• Inability to give informed consent
• On systemic corticosteroids at unstable doses or on regular daily doses of 20 mg or more of prednisone (or equivalent)
• Not fully recovered from an exacerbation of COPD for at least 30 days
• Inability to perform light to moderate activity for orthopedic reasons or who significantly desaturated with exercise (percentage of available hemoglobin that is saturated with oxygen \[SaO\_2\] \< 85% on screening test
• Healthy controls -
• \- Age and gender matched to COPD participants
• \- Subjects who are unable to engage in exercise testing due to existing comorbidities

Sponsors & Collaborators

• Mayo Clinic: lead
• Boehringer Ingelheim: collaborator
• Pfizer: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Bruce D. Johnson, PhD
• Organization: Mayo Clinic

johnson.bruce@mayo.edu

507-284-4441

Study Officials

• Bruce D Johnson, Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 21, 2007
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 26, 2012
• Results First Posted: June 26, 2012

Record last verified: 2012-05

Locations

US (1)