Clinical trial NCT01360398: Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly
Official title: Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disorders
Keywords: pathogen
Chronic Obstructive Pulmonary Disease
Acute Exacerbations of Chronic Obstructive Pulmonary Disease
COPD
respiratory
AECOPD
exacerbation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Primary outcomes:
measure: Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
timeFrame: During year 1
measure: Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
timeFrame: During Year 1
measure: Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
timeFrame: During Year 1
Secondary outcomes:
measure: Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
timeFrame: During Year 1
measure: Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
timeFrame: During Year 1
measure: Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
timeFrame: During Year 1
measure: Mean Number of Days Between 2 Consecutive AECOPDs
timeFrame: During Year 1
measure: Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
timeFrame: During Year 1
measure: Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
timeFrame: During Year 1
measure: Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
timeFrame: During Year 1
measure: Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
timeFrame: During Year 1
measure: Number of Subjects Receiving Various Health Care Types During AECOPD
timeFrame: During Year 1
measure: Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal
timeFrame: During Year 1
measure: AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
timeFrame: During Year 1
measure: AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
timeFrame: During Year 1
measure: Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
timeFrame: During Year 1
measure: Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
timeFrame: During Year 1
measure: Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
timeFrame: During Year 1
measure: AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
timeFrame: During Year 1
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bourne S, Cohet C, Kim V, Barton A, Tuck A, Aris E, Mesia-Vela S, Devaster JM, Ballou WR, Clarke SC, Wilkinson T. Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study. BMJ Open. 2014 Mar 7;4(3):e004546. doi: 10.1136/bmjopen-2013-004546.
citation: Mayhew D, Devos N, Lambert C, Brown JR, Clarke SC, Kim VL, Magid-Slav M, Miller BE, Ostridge KK, Patel R, Sathe G, Simola DF, Staples KJ, Sung R, Tal-Singer R, Tuck AC, Van Horn S, Weynants V, Williams NP, Devaster JM, Wilkinson TMA; AERIS Study Group. Longitudinal profiling of the lung microbiome in the AERIS study demonstrates repeatability of bacterial and eosinophilic COPD exacerbations. Thorax. 2018 May;73(5):422-430. doi: 10.1136/thoraxjnl-2017-210408. Epub 2018 Jan 31.
citation: Wilkinson TMA, Van den Steen P, Cheuvart B, Baudson N, Dodet M, Turriani E, Harrington L, Meyer N, Rondini S, Taddei L, Mukherjee P. Seroprevalence of Bordetella pertussis Infection in Patients With Chronic Obstructive Pulmonary Disease in England: Analysis of the AERIS Cohort. COPD. 2021 Jun;18(3):341-348. doi: 10.1080/15412555.2021.1920904. Epub 2021 May 6.
citation: Malvisi L, Taddei L, Yarraguntla A, Wilkinson TMA, Arora AK; AERIS Study Group. Sputum sample positivity for Haemophilus influenzae or Moraxella catarrhalis in acute exacerbations of chronic obstructive pulmonary disease: evaluation of association with positivity at earlier stable disease timepoints. Respir Res. 2021 Feb 24;22(1):67. doi: 10.1186/s12931-021-01653-8.
citation: Germovsek E, Ambery C, Yang S, Beerahee M, Karlsson MO, Plan EL. A Novel Method for Analysing Frequent Observations from Questionnaires in Order to Model Patient-Reported Outcomes: Application to EXACT(R) Daily Diary Data from COPD Patients. AAPS J. 2019 Apr 26;21(4):60. doi: 10.1208/s12248-019-0319-9.
citation: Wilkinson TMA, Aris E, Bourne SC, Clarke SC, Peeters M, Pascal TG, Taddei L, Tuck AC, Kim VL, Ostridge KK, Staples KJ, Williams NP, Williams AP, Wootton SA, Devaster JM. Drivers of year-to-year variation in exacerbation frequency of COPD: analysis of the AERIS cohort. ERJ Open Res. 2019 Feb 25;5(1):00248-2018. doi: 10.1183/23120541.00248-2018. eCollection 2019 Feb.
citation: Williams NP, Ostridge K, Devaster JM, Kim V, Coombs NA, Bourne S, Clarke SC, Harden S, Abbas A, Aris E, Lambert C, Tuck A, Williams A, Wootton S, Staples KJ, Wilkinson TMA; AERIS Study Group. Impact of radiologically stratified exacerbations: insights into pneumonia aetiology in COPD. Respir Res. 2018 Jul 28;19(1):143. doi: 10.1186/s12931-018-0842-8.
citation: Wilkinson TMA, Aris E, Bourne S, Clarke SC, Peeters M, Pascal TG, Schoonbroodt S, Tuck AC, Kim V, Ostridge K, Staples KJ, Williams N, Williams A, Wootton S, Devaster JM; AERIS Study Group. A prospective, observational cohort study of the seasonal dynamics of airway pathogens in the aetiology of exacerbations in COPD. Thorax. 2017 Oct;72(10):919-927. doi: 10.1136/thoraxjnl-2016-209023. Epub 2017 Apr 21.