COPD Clinical Trial
Official title:
Multiplex Molecular Detection of Respiratory Pathogens of Adult Patients Admitted to Hospital for Exacerbation of Asthma and Chronic Obstructive Pulmonary Disease and Their Clinical Outcomes.
To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute
exacerbation of COPD and asthma who required hospitalization.
To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.
To assess if the infective aetiologies have associations with the clinical outcome of the
patients.
Objective: Chronic obstructive pulmonary disease (COPD) and asthma exacerbations both
contribute to significant health care burden. Viral infections are important cause of acute
exacerbation of COPD and asthma.
Hypothesis to be tested: 1. Assess infective etiologies by Multiplex Molecular Detection of
nasopharyngeal aspirate (NPA) of patients with acute exacerbation of COPD and asthma; 2.
Identify the human rhinovirus (HRV) (the commonest virus causing exacerbations) subtypes
involved; 3.Assess if the infective etiologies have associations with clinical outcome of the
patients.
Design and subjects: Prospective observational study. Patients admitted to hospital for acute
exacerbation of COPD and asthma. Stable COPD and asthma patients will be recruited as
controls.
Study instruments: Multiplex Molecular Detection of respiratory pathogens from NPA. Clinical
data of the patient will be collected and spirometry will be performed.
Interventions: NPA collection from subjects. Main outcome measures: Primary aim is assessment
of the prevalence of different viruses in relation to acute exacerbation of asthma and COPD.
Secondary aim is to assess if a certain pathogen is associated with clinical outcomes
including duration of hospitalization and 30 and 60 day readmissions and mortality Data
analysis: Data will be analyzed by the Statistical Package of the Social Science Statistical
software for Window, Version 22 (IBM SPSS Inc, IL, USA). Statistical methods including
chi-square test, student t test and ANOVA will be used as appropriate.
Expected results: Understanding the epidemiology of respiratory viruses in COPD and asthma
exacerbations allows further investigations of treatment options and gives information about
the prognosis.
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