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Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

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ClinicalTrials.gov Identifier: NCT01376830
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 35 participants
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
Study Start Date : June 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013
Groups and Cohorts

Group/Cohort
COPD patients


Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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


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

Publications:

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

Keywords provided by Imperial College London:
COPD
Exacerbations
Viruses

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