We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations (VICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00448604
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : November 4, 2010
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva

Brief Summary:

The objectives of the study are

  • to determine the prevalence of respiratory virus infections in COPD patients, during and outside acute exacerbation
  • to explore the impact of these viral infections on the outcome of these patients
  • to explore the association between blood procalcitonin levels and viral infections in this population.

Condition or disease
Pulmonary Disease, Chronic Obstructive Respiratory Tract Infections Virus Diseases Lung Diseases, Obstructive

Detailed Description:


Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity due to repeated exacerbations. The impact of viral infections during and outside COPD exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of COPD exacerbations.

Objectives of the project

The investigators aim to

  1. describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD;
  2. explore the evolution of viral infections outside exacerbations;
  3. analyze the impact of viral infections on clinical outcomes;
  4. explore the role of biological markers (CRP, procalcitonin) for the diagnosis and prognosis of viral infections.


The investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their COPD. Virological samples will be obtained at admission and at 3 months, to explore the evolution outside episodes of acute exacerbation. Clinical information will be obtained after one-year follow-up. Samples will be tested by RT-PCR for 15 respiratory viruses. The impact of viral infections and the role of biological markers will be explored using univariate and multivariate Cox proportional hazard models.

Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases: Virological Work-up During Exacerbations and 1-year Follow-up
Study Start Date : May 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Naso-pharyngeal swaps

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COPD admitted with acute exacerbation

Inclusion Criteria:

  • All consecutive patients known or suspected for moderate to very severe COPD and admitted in the emergency center for an acute exacerbation of their COPD
  • Age above 18 years
  • We plan to include 100 patients with a complete work-up and follow-up
  • Written informed consent will be obtained from every participant

Exclusion Criteria:

  • Patients requiring oro-tracheal intubation
  • Patients unable to give their informed consent due to their clinical condition
  • Other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia)
  • Patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis
  • Patients with a history of active tuberculosis
  • Patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448604

Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Ligue Pulmonaire Genevoise
Principal Investigator: Olivier T Rutschmann, MD, MPH Geneva University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: O. Rutschmann, HUG, Geneva
ClinicalTrials.gov Identifier: NCT00448604     History of Changes
Other Study ID Numbers: 06-257
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: February 2009

Keywords provided by University Hospital, Geneva:
acute exacerbation
Biological Markers

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Communicable Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Infections
Virus Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes