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Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 20, 2011
Last Update Posted: August 24, 2015
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.
Information provided by (Responsible Party):
Imperial College London
Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies have potential as treatments for exacerbations. However it is likely that treating patients when they present with an exacerbation with antiviral drugs will be too late to be effective and earlier treatment at the time of the initial upper respiratory tract infection (URTI) will be required. The incidence of exacerbations following URTIs in COPD patients, and whether there are host factors and biomarkers that can identify the risk of this, is unknown. The aims of this study are to establish the proportion of viral URTIs that progress to an acute exacerbation in COPD patients and identify clinical, viral and biological markers that predict risk of an exacerbation following an URTI. In addition we will determine the frequency of, and risk factors for, bacterial infection following viral URTIs in COPD patients. This data will permit development of a model combining baseline patient characteristics, clinical measurements and biomarkers to predict exacerbation risk following viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in COPD exacerbations and targeting of treatment to high risk patients.

Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers and Clinical Characteristics That Identify the Risk of an Exacerbation Following Viral Upper Respiratory Tract Infections in COPD Patients

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Proportion of colds followed by exacerbations in COPD patients [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Clinical characteristics that identify high risk of exacerbation following a cold in COPD patients [ Time Frame: 2 years ]
  • Biomarkers that identify the risk of exacerbation following colds in COPD patients [ Time Frame: 2 years ]
  • Changes in bacterial flora following colds in COPD patients [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Sputum,nasal lavage, serum

Enrollment: 35
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
COPD patients

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients

Inclusion Criteria:

  • COPD
  • Age 40-85

Exclusion Criteria:

  • Unable to understand English
  • Expected life expectancy < 2 years
  • Unable to attend hospital
  Contacts and Locations
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): NCT01376830

United Kingdom
Imperial College
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Principal Investigator: Patrick Mallia, MD, PhD Imperial College London
  More Information


Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01376830     History of Changes
Other Study ID Numbers: CRO1697
First Submitted: June 17, 2011
First Posted: June 20, 2011
Last Update Posted: August 24, 2015
Last Verified: June 2011

Keywords provided by Imperial College London:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases