Interaction in Chronic Obstructive Pulmonary Disease Experiment (ICE)
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation |
Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin) Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease |
- 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 ] [ Designated as safety issue: Yes ]
- (hs)CRP [ Time Frame: 3 times within 2 hours for each arm ] [ Designated as safety issue: Yes ]
- fibrinogen [ Time Frame: 3 times within 2 hours for each arm ] [ Designated as safety issue: Yes ]
- respiratory function [ Time Frame: at baseline and repeatedly around medication inhalation for 1.5 hours ] [ Designated as safety issue: No ]
- smoking pattern: smoke inhalation and smoke exhalation time and volume [ Time Frame: during smoking cigarettes: twice for each arm. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: beta 2 agonist + anticholinergic aerosol |
Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin)
1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking
Other Names:
|
| Placebo Comparator: placebo inhalation |
Drug: placebo
1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking
Other Name: Ventolin placebo and Spiriva placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value).
- Current cigarette smoking (at the time of performing the study).
- Willing to provide written informed consent.
- Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test.
- Registered in one of the recruitment institutes.
Exclusion Criteria:
- COPD gold stage I or IV.
- Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted.
- Unable to communicate.
- Physically unable to perform any of the tests.
- Non-COPD respiratory disorders.
- Previous lung-volume reduction surgery and/or lung transplantation.
- Evidence of alcohol, drug or solvent abuse.
- Known α-1 antitrypsin deficiency.
Contacts and Locations| Netherlands | |
| University Center for Chronic Diseases Dekkerswald | |
| Groesbeek, Netherlands | |
| Primary care, general practitioners | |
| Nijmegen, Netherlands | |
| Principal Investigator: | Tjard RJ Schermer, PhD | Radboud University Nijmegen Medical Center |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | TRJ Schermer, PhD, Radboud University Nijmegen Medical Center |
| ClinicalTrials.gov Identifier: | NCT00981851 History of Changes |
| Other Study ID Numbers: | RvB08.066.51196/GE |
| Study First Received: | September 21, 2009 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
intervention study interaction COPD |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Smoking Lung Diseases, Obstructive Respiratory Tract Diseases Habits Albuterol Tiotropium Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 21, 2013