Phase 4 N=36 Randomized Double-blind Treatment

Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation

Chronic Obstructive Pulmonary Disease · COPD

Bottom Line

View on ClinicalTrials.gov: NCT00578968 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2012

Primary outcome: Primary: Baseline Resting Cardiac Index (CI) — 2.4; 2.36 L/min/m^2 — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tiotropium (Drug); Placebo (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Resting Cardiac Index (CI)	2.4; 2.36	0.85
PRIMARY Baseline Resting Stroke Volume Index (SVI)	31.3; 39.7	0.03 sig
PRIMARY Pretreatment Peak Exercise CI	5.34; 6.70	0.04 sig
PRIMARY Pretreatment Peak Exercise SVI	44.62; 50.06	0.19
SECONDARY Baseline Resting Forced Vital Capacity (FVC)	3.29; 4.20	0.01 sig
SECONDARY Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)	78.3; 99.4	<0.001 sig
SECONDARY Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)	1.74; 3.22	<0.001 sig
SECONDARY Baseline Resting FEV_1 as Percentage of Predicted FEV_1	51.6; 97.5	<0.001 sig
SECONDARY Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups	79.4; 72.7; 127.8; 153.6	0.13
SECONDARY Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)	1.52; 2.29	<0.001 sig
SECONDARY Baseline Peak Exercise Cardiac Index (CI)	6.02; 7.61	<0.05 sig
SECONDARY Baseline Peak Exercise Stroke Volume Index (SVI)	47.3; 52.7	0.15
SECONDARY Pretreatment Resting Forced Vital Capacity (FVC)	2.79; 3.80	0.01 sig
SECONDARY Pretreatment Resting FVC as Percentage of Predicted FVC	71.24; 85.27	0.009 sig
SECONDARY Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period	11.55; -6.20	0.005 sig
SECONDARY Pretreatment Resting FEV_1	1.48; 2.00	0.06
SECONDARY Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period	8.81; -6.30	0.003 sig
SECONDARY Pretreatment Resting CI	2.31; 2.49	0.60
SECONDARY Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period	-4.91; -9.08	0.35
SECONDARY Pretreatment Resting SVI	30.08; 32.55	0.65
SECONDARY Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period	-3.80; -6.26	0.43
SECONDARY Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups	80.50; 78.33; 120.17; 135.33	0.73
SECONDARY Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period	-7.05; -1.32	0.22
SECONDARY Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)	1.33; 1.65	0.06
SECONDARY Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period	2.06; -4.60	0.09
SECONDARY Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period	2.46; -11.80	0.04 sig
SECONDARY Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period	3.11; -4.95	0.16
SECONDARY Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period	0.27; -7.05	0.04 sig

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).

Eligibility Criteria

Chronic obstructive pulmonary disease (COPD) participants-

Inclusion criteria

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

Exclusion criteria

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 -

Inclusion:

Age and gender matched to COPD participants

Exclusion:

Subjects who are unable to engage in exercise testing due to existing comorbidities

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00578968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.