Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01376830
First received: June 17, 2011
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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
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

Resource links provided by NLM:


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


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients

  Show Detailed Description

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376830

Contacts
Contact: Patrick Mallia, MD, PhD 02075943751 p.mallia@imperial.ac.uk
Contact: Sebastian L Johnston, MD, PhD 020 7594 3764 s.johnston@imperial.ac.uk

Locations
United Kingdom
Imperial College Not yet recruiting
London, United Kingdom, W2 1PG
Contact: Patrick Mallia, MD, PhD    02075943751    p.mallia@imperial.ac.uk   
Principal Investigator: Patrick Mallia, MD, PhD         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Patrick Mallia, MD, PhD Imperial College London
  More Information

Publications:

Responsible Party: Dr Patrick Mallia, Imperial College
ClinicalTrials.gov Identifier: NCT01376830     History of Changes
Other Study ID Numbers: CRO1697
Study First Received: June 17, 2011
Last Updated: June 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
COPD
Exacerbations
Viruses

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

ClinicalTrials.gov processed this record on July 31, 2014