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Interaction in Chronic Obstructive Pulmonary Disease Experiment (ICE)

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ClinicalTrials.gov Identifier: NCT00981851
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE September 21, 2009
First Posted Date  ICMJE September 22, 2009
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00981851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
  • (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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction in Chronic Obstructive Pulmonary Disease Experiment
Official Title  ICMJE A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease
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?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Cardiovascular Disease
  • Smoking
  • Bronchodilation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: beta 2 agonist + anticholinergic aerosol
    Intervention: Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin)
  • Placebo Comparator: placebo inhalation
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 21, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981851
Other Study ID Numbers  ICMJE RvB08.066.51196/GE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TRJ Schermer, PhD, Radboud University Nijmegen Medical Center
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tjard RJ Schermer, PhD Radboud University Nijmegen Medical Center
PRS Account Radboud University
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP