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| Sponsors and Collaborators: |
Mayo Clinic Boehringer Ingelheim Pharmaceuticals Pfizer |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00578968 |
Purpose
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 obstructionve pulmonary disease.
| Condition | Intervention |
|---|---|
|
COPD |
Drug: Tiotropium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Aim 1. To determine the influence of the long-acting anticholinergic agent Tiotropium (Spiriva) on cardiac function at rest in patients with moderate to severe COPD (FEV1<65% predicted). Measures of cardiac function will include assessment cardiac output as well as echocardiographic measures of right ventricular function, pulmonary vascular pressures, as well as left ventricular function, both systolic and diastolic.
Aim 2. To determine the influence of the long-acting anticholinergic agent Tiotropium (Spiriva) on cardiac function during exercise in patients with moderate to severe COPD (FEV1<65% predicted). Exercise will be performed both submaximally in the semi-recumbent position to obtain more detailed cardiac measures as well as in the upright position at a more moderate intensity with measures of cardiac output only. Measures will be made pre/post Tiotropium at matched exercise times along with measures of end expiratory lung volume and esophageal and gastric pressures.
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
BMI<35. COPD. FEV1 <65 % age predicted. Smoking history of >10 pack years. No daytime oxygen
Contacts and Locations More Information
| Responsible Party: | Mayo Clinic ( Bruce Johnson, PhD ) |
| Study ID Numbers: | 06-003434 |
| Study First Received: | December 20, 2007 |
| Last Updated: | August 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00578968 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Lung Diseases, Obstructive Cholinergic Antagonists Respiratory Tract Diseases Lung Diseases Anti-Asthmatic Agents |
Peripheral Nervous System Agents Cholinergic Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
|
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
