Interaction in Chronic Obstructive Pulmonary Disease Experiment

Overview

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?

Full Title of Study: “A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: beta 2 agonist + anticholinergic aerosol
  • Placebo Comparator: placebo inhalation

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • (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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University
  • Provider of Information About this Clinical Study
    • TRJ Schermer, PhD, Radboud University Nijmegen Medical Center
  • Overall Official(s)
    • Tjard RJ Schermer, PhD, Principal Investigator, Radboud University Nijmegen Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.