Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

This study has been completed.
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: June 17, 2011
Last updated: August 21, 2015
Last verified: June 2011
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical characteristics that identify high risk of exacerbation following a cold in COPD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biomarkers that identify the risk of exacerbation following colds in COPD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Changes in bacterial flora following colds in COPD patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

  Show Detailed Description


Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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 Identifier: NCT01376830     History of Changes
Other Study ID Numbers: CRO1697
Study First Received: June 17, 2011
Last Updated: August 21, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases processed this record on November 30, 2015