Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01360398
First received: May 24, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The aim of this study is to generate epidemiological data to further explore determinants of Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral pathogens to Acute Exacerbation of COPD (AECOPD) episodes.


Condition Intervention
Respiratory Disorders
Procedure: Blood sample
Procedure: Sputum sample
Procedure: Nasopharyngeal swab
Procedure: Urine sample
Procedure: End tidal breath sample
Other: Data collection
Other: Tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of all-cause AECOPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of AECOPD having sputum containing bacterial pathogens, as detected by culture [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of AECOPD having sputum containing bacterial pathogens, as detected by Polymerase Chain Reaction (PCR) [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of bacterial pathogens by severity of AECOPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of bacterial pathogens in stable COPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of AECOPD having sputum containing viral pathogens [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of viral pathogens by severity of AECOPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Number of days between consecutive AECOPD episodes [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Exacerbations of Chronic Pulmonary Disease Tool (EXACT) score in all-cause AECOPD and in stable COPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • COPD Assessment Test (CAT) score in all-cause AECOPD and in stable COPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Nottingham Extended Activities of Daily Living Scale (NEADL) score in all-cause AECOPD and in stable COPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • EQ-5D index and Visual Analogue Scale (VAS) score in all-cause AECOPD and in stable COPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of healthcare use for all-cause AECOPD [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]
  • Occurrence of healthcare use for AECOPD having sputum containing bacterial and /or viral pathogens [ Time Frame: During the entire study period (2 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort
COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.
Procedure: Blood sample
Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.
Procedure: Sputum sample
Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.
Procedure: Nasopharyngeal swab
Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.
Procedure: Urine sample
Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.
Procedure: End tidal breath sample
Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.
Other: Data collection
Patient interview, diary cards review and questionnaires completion
Other: Tests
Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male or female subjects between, and including, 40 and 85 years of age, at the time of consent.
  • Subjects with confirmed diagnosis of COPD with Forced Expiratory Volume of air expired in 1 second (FEV1) of </=80% of predicted normal and FEV1/Forced expiratory Vital Capacity (FVC)<0.7
  • Subjects have moderate, severe, or very severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging.
  • Subjects have a current or prior history of >/=10 pack-years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked.
  • Subjects present a documented history of >/=1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalization in the previous 12 months.

Exclusion Criteria:

  • Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders.
  • Subjects having undergone lung surgery.
  • Subject has a α-1 antitrypsin deficiency as underlying cause of COPD.
  • Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids.
  • Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit.
  • Subject has other conditions that the principal investigator judges may interfere with the study findings. Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  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: NCT01360398

Locations
United Kingdom
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01360398     History of Changes
Other Study ID Numbers: 114378
Study First Received: May 24, 2011
Last Updated: March 27, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
pathogen
Chronic Obstructive Pulmonary Disease
Acute Exacerbations of Chronic Obstructive Pulmonary Disease
COPD
respiratory
AECOPD
exacerbation

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

ClinicalTrials.gov processed this record on July 09, 2014