Interaction in Chronic Obstructive Pulmonary Disease Experiment

Chronic Obstructive Pulmonary Disease Clinical Trial

— ICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981851
• Other study ID #: RvB08.066.51196/GE
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: July 4, 2011
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 a-1 antitrypsin deficiency.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Bronchodilation
• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smoking

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Center for Chronic Diseases Dekkerswald	Groesbeek
Netherlands	Primary care, general practitioners	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cigarette smoke retention		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	Yes
Secondary	(hs)CRP		3 times within 2 hours for each arm	Yes
Secondary	fibrinogen		3 times within 2 hours for each arm	Yes
Secondary	respiratory function		at baseline and repeatedly around medication inhalation for 1.5 hours	No
Secondary	smoking pattern: smoke inhalation and smoke exhalation time and volume		during smoking cigarettes: twice for each arm.	No