Interaction in Chronic Obstructive Pulmonary Disease Experiment (ICE)

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00981851
First received: September 21, 2009
Last updated: July 4, 2011
Last verified: October 2009
  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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • (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:
  • 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

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981851

Locations
Netherlands
University Center for Chronic Diseases Dekkerswald
Groesbeek, Netherlands
Primary care, general practitioners
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 01, 2014