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Interaction in Chronic Obstructive Pulmonary Disease Experiment (ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981851
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : July 6, 2011
Information provided by:
Radboud University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin) Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease
Study Start Date : September 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
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:
  • Spiriva Respimat
  • Ventolin Aerosol

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. (hs)CRP [ Time Frame: 3 times within 2 hours for each arm ]
  2. fibrinogen [ Time Frame: 3 times within 2 hours for each arm ]
  3. respiratory function [ Time Frame: at baseline and repeatedly around medication inhalation for 1.5 hours ]
  4. smoking pattern: smoke inhalation and smoke exhalation time and volume [ Time Frame: during smoking cigarettes: twice for each arm. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981851

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University Center for Chronic Diseases Dekkerswald
Groesbeek, Netherlands
Primary care, general practitioners
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
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Principal Investigator: Tjard RJ Schermer, PhD Radboud University Nijmegen Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: TRJ Schermer, PhD, Radboud University Nijmegen Medical Center Identifier: NCT00981851    
Other Study ID Numbers: RvB08.066.51196/GE
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: October 2009
Keywords provided by Radboud University:
intervention study
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents