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Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly | Clinical Trials | Clareo Health

COMPLETEDNA

Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly

NCT01360398•GlaxoSmithKline

Summary

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.

Eligibility

Age

40 - 85 years

Sex

ALL

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.

Locations (1)

GSK Investigational Site

Southampton, Hampshire, United Kingdom

Key Dates

Start Date

June 30, 2011

Primary Completion Date

June 27, 2014

Completion Date

June 27, 2014

Last Updated

February 15, 2019

Enrollment

127

ACTUAL participants

Conditions

Respiratory Disorders

Interventions

Blood sample

PROCEDURE

Sputum sample

PROCEDURE

Nasopharyngeal swab

PROCEDURE

Urine sample

PROCEDURE

End tidal breath sample

PROCEDURE

Data collection

OTHER

Tests

OTHER

Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

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COMPLETEDPHASE2

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NCT03281876

Respiratory Disorders

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COMPLETEDPHASE1

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

Inclusion Criteria

Exclusion Criteria

Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

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