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Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study

Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study
Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study

INTRODUCTION: The aetiology of acute exacerbations of chronic obstructive pulmonary disease (COPD) remains incompletely understood and strategies for treatment and prevention have not altered significantly for many years. Improved understanding of the role of respiratory pathogens in acute exacerbations of COPD (AECOPD) is required and the use of molecular microbiological techniques may lead to insights into host-pathogen interactions and the development of more targeted therapeutic approaches.

METHODS AND ANALYSES: Acute Exacerbation and Respiratory InfectionS in COPD (AERIS) is a longitudinal epidemiological study to assess how changes in the COPD airway microbiome contribute to the incidence and severity of AECOPD. Patients with COPD aged 40-85 are followed monthly for 2 years, and reviewed within 72 h of onset of symptoms of AECOPD. Exacerbations are detected using daily electronic diary cards. Blood, sputum, nasopharyngeal and urine samples are collected at prespecified timepoints. Molecular diagnostic and typing techniques are used to describe the dynamics of airway infection during AECOPD and stable disease, and associations with clinical outcome. This study aims to refine the case definition of AECOPD to reflect the possible microbiological aetiology. AERIS will assess the impact of AECOPD on health-related quality of life and healthcare resource utilisation, and the possible interactions between nutritional status, infection and immune responses.

ETHICS AND DISSEMINATION: AERIS is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, and has been approved by the institutional ethics and review board. All participants must provide written informed consent. The results obtained will be disseminated at international medical conferences and in peer-reviewed publications.

DISCUSSION: Few other studies have addressed the complexity of the microbiological and systemic components of COPD or employed real-time electronic tracking of symptoms to identify AECOPD and potential aetiological triggers.

RESULTS: Results of AERIS will increase our understanding of the contribution of pathogens to AECOPD, potentially leading to new targeted therapeutic and preventative interventions.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01360398.

Adult, Aged, Aged, 80 and over, Clinical Protocols, Disease Progression, Female, Health Services/statistics & numerical data, Humans, Longitudinal Studies, Male, Microbiological Techniques, Middle Aged, Molecular Diagnostic Techniques, Nutritional Status, Prospective Studies, Pulmonary Disease, Chronic Obstructive/microbiology, Quality of Life, Research Design, Respiratory Tract Infections/diagnosis, United Kingdom
2044-6055
Bourne, Simon
b5efbc3f-70be-426f-9d45-9015bb90c8b3
Cohet, Catherine
75847223-055e-462f-999a-d9305919c63a
Kim, Viktoriya
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Barton, Anna
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Tuck, Andy
bf428e72-b3a3-418b-95e2-a35415eeb285
Aris, Emmanuel
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Mesia-Vela, Sonia
71407f65-ae37-496e-917d-fa0c438d8859
Devaster, Jeanne-Marie
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Ballou, W Ripley
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Clarke, Stuart C
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Wilkinson, Tom M.A.
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Bourne, Simon
b5efbc3f-70be-426f-9d45-9015bb90c8b3
Cohet, Catherine
75847223-055e-462f-999a-d9305919c63a
Kim, Viktoriya
b7fe2e0f-95b4-4224-96a8-a7e66155625e
Barton, Anna
e1de2b88-233d-46ca-b693-0fbbe4210b56
Tuck, Andy
bf428e72-b3a3-418b-95e2-a35415eeb285
Aris, Emmanuel
2203e7f8-8fa1-40c0-be30-99f142655835
Mesia-Vela, Sonia
71407f65-ae37-496e-917d-fa0c438d8859
Devaster, Jeanne-Marie
36195bcf-0cae-40cc-8ee2-d389a4a65a13
Ballou, W Ripley
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Clarke, Stuart C
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Wilkinson, Tom M.A.
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Bourne, Simon, Cohet, Catherine, Kim, Viktoriya, Barton, Anna, Tuck, Andy, Aris, Emmanuel, Mesia-Vela, Sonia, Devaster, Jeanne-Marie, Ballou, W Ripley, Clarke, Stuart C and Wilkinson, Tom M.A. (2014) Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study. BMJ Open, 4 (3), [e004546]. (doi:10.1136/bmjopen-2013-004546).

Record type: Article

Abstract

INTRODUCTION: The aetiology of acute exacerbations of chronic obstructive pulmonary disease (COPD) remains incompletely understood and strategies for treatment and prevention have not altered significantly for many years. Improved understanding of the role of respiratory pathogens in acute exacerbations of COPD (AECOPD) is required and the use of molecular microbiological techniques may lead to insights into host-pathogen interactions and the development of more targeted therapeutic approaches.

METHODS AND ANALYSES: Acute Exacerbation and Respiratory InfectionS in COPD (AERIS) is a longitudinal epidemiological study to assess how changes in the COPD airway microbiome contribute to the incidence and severity of AECOPD. Patients with COPD aged 40-85 are followed monthly for 2 years, and reviewed within 72 h of onset of symptoms of AECOPD. Exacerbations are detected using daily electronic diary cards. Blood, sputum, nasopharyngeal and urine samples are collected at prespecified timepoints. Molecular diagnostic and typing techniques are used to describe the dynamics of airway infection during AECOPD and stable disease, and associations with clinical outcome. This study aims to refine the case definition of AECOPD to reflect the possible microbiological aetiology. AERIS will assess the impact of AECOPD on health-related quality of life and healthcare resource utilisation, and the possible interactions between nutritional status, infection and immune responses.

ETHICS AND DISSEMINATION: AERIS is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, and has been approved by the institutional ethics and review board. All participants must provide written informed consent. The results obtained will be disseminated at international medical conferences and in peer-reviewed publications.

DISCUSSION: Few other studies have addressed the complexity of the microbiological and systemic components of COPD or employed real-time electronic tracking of symptoms to identify AECOPD and potential aetiological triggers.

RESULTS: Results of AERIS will increase our understanding of the contribution of pathogens to AECOPD, potentially leading to new targeted therapeutic and preventative interventions.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01360398.

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Published date: 7 March 2014
Keywords: Adult, Aged, Aged, 80 and over, Clinical Protocols, Disease Progression, Female, Health Services/statistics & numerical data, Humans, Longitudinal Studies, Male, Microbiological Techniques, Middle Aged, Molecular Diagnostic Techniques, Nutritional Status, Prospective Studies, Pulmonary Disease, Chronic Obstructive/microbiology, Quality of Life, Research Design, Respiratory Tract Infections/diagnosis, United Kingdom

Identifiers

Local EPrints ID: 453850
URI: http://eprints.soton.ac.uk/id/eprint/453850
ISSN: 2044-6055
PURE UUID: f9ac947d-66b3-4721-beb1-dbebb4f2189e
ORCID for Stuart C Clarke: ORCID iD orcid.org/0000-0002-7009-1548

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Date deposited: 25 Jan 2022 17:39
Last modified: 26 Jan 2022 02:39

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Contributors

Author: Simon Bourne
Author: Catherine Cohet
Author: Viktoriya Kim
Author: Anna Barton
Author: Andy Tuck
Author: Emmanuel Aris
Author: Sonia Mesia-Vela
Author: Jeanne-Marie Devaster
Author: W Ripley Ballou
Author: Stuart C Clarke ORCID iD
Author: Tom M.A. Wilkinson

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