Interaction in Chronic Obstructive Pulmonary Disease Experiment

NCT00981851 | Completed

• 1 other identifier: RvB08.066.51196/GE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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?

Conditions

Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Smoking; Bronchodilation

Keywords

intervention study; interaction; COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• (hs)CRP

  3 times within 2 hours for each arm

• fibrinogen

  3 times within 2 hours for each arm

• respiratory function

  at baseline and repeatedly around medication inhalation for 1.5 hours

• smoking pattern: smoke inhalation and smoke exhalation time and volume

  during smoking cigarettes: twice for each arm.

Study Arms (2)

beta 2 agonist + anticholinergic aerosol

ACTIVE COMPARATOR

Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin)

placebo inhalation

PLACEBO COMPARATOR

Drug: placebo

Interventions

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

Also known as: Spiriva Respimat, Ventolin Aerosol

beta 2 agonist + anticholinergic aerosol

placebo DRUG

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

Also known as: Ventolin placebo and Spiriva placebo

placebo inhalation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

University Center for Chronic Diseases Dekkerswald

Groesbeek, Netherlands

Location

Primary care, general practitioners

Nijmegen, Netherlands

Location

Related Publications (2)

• van Dijk WD, Heijdra Y, Lenders JW, Klerx W, Akkermans R, van der Pouw A, van Weel C, Scheepers PT, Schermer TR. Cigarette smoke retention and bronchodilation in patients with COPD. A controlled randomized trial. Respir Med. 2013 Jan;107(1):112-9. doi: 10.1016/j.rmed.2012.09.019. Epub 2012 Oct 12.

  PMID: 23069326 DERIVED

• van Dijk WD, Scheepers PT, Cremers R, Lenders JW, Klerx W, van Weel C, Schermer TR, Heijdra Y. A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial. Trials. 2011 Feb 10;12:37. doi: 10.1186/1745-6215-12-37.

  PMID: 21310040 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Smoking

Interventions

Tiotropium Bromide; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Tjard RJ Schermer, PhD

  Radboud University Nijmegen Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2009-10

Locations

NL (2)