Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Respiratory Disorders

Treatments: Procedure: Sputum sample; Other: Data collection; Procedure: Blood sample; Procedure: End tidal breath sample; Procedure: Nasopharyngeal swab; Other: Tests; Procedure: Urine sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360398

114378

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 1 patient group

Cohort

Other group

Description:

COPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.

Treatment:

Other: Tests

Procedure: Urine sample

Procedure: Nasopharyngeal swab

Procedure: End tidal breath sample

Procedure: Sputum sample

Other: Data collection

Procedure: Blood sample