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Completed

NCT Number: NCT00981851

Interaction in Chronic Obstructive Pulmonary Disease Experiment

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?

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center for Chronic Diseases Dekkerswald, Groesbeek, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tiotropium (Spiriva) + Salbutamol (Ventolin)

Drug

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

Drug

1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking

Other names: Ventolin placebo and Spiriva placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease

Acronym: ICE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2009
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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