An interventional study of Tiotropium (Spiriva) + Salbutamol (Ventolin) and placebo in Chronic Obstructive Pulmonary Disease, Cardiovascular Disease and Smoking, sponsored by Radboud University Medical Center. Completed at 2 sites in Netherlands. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-07-06.
Sponsored by Radboud University Medical Center · Not applicable and Interventional
The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?
COPD currently is one of the most frequent diseases. In more than 80% of COPD patients, the disease is caused by smoking. About half of the COPD patients are active smokers, although smoking is also the most important prognostic factor. Also, smoking is an important cause as well as an important prognostic factor in cardiovascular disease. The corner stone of medical treatment in COPD is bronchodilation; more than half of the patients use a long-acting bronchodilator. An increase of the pathogenic effect of smoking by an increased lung function after bronchodilation is likely though, since more pathogenic particles would penetrate the lung. We hypothesize that bronchodilators increase cardiovascular disease in COPD patients who smoke.
In order to demonstrate the basic mechanism of our hypothesis, COPD patients receive a bronchodilator at one time and a placebo at another time, preceded and followed by cigarette smoking during one hour as by a strict time schedule. Smoke retention, lung function and blood biomarkers are repeatedly measured.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin)
Drug: placebo
Drug page: Tiotropium
1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking
Also known as: Spiriva Respimat, Ventolin Aerosol
1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking
Also known as: Ventolin placebo and Spiriva placebo
cigarette smoke retention
Time frame: retention measurement is during smoking. smoking is 1 cigarette before and 1 cigarette 45 minutes after medication inhalation for each arm. 1 week between arms
(hs)CRP
Time frame: 3 times within 2 hours for each arm
fibrinogen
Time frame: 3 times within 2 hours for each arm
respiratory function
Time frame: at baseline and repeatedly around medication inhalation for 1.5 hours
smoking pattern: smoke inhalation and smoke exhalation time and volume
Time frame: during smoking cigarettes: twice for each arm.
The record gives a start of Sep 2009, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tiotropium
Pulmonary Disease, Chronic Obstructive →
Radboud University Medical Center →