Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

NCT01360398 | Completed Results

• 1 other identifier: 114378
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disorders

Keywords

pathogen; Chronic Obstructive Pulmonary Disease; Acute Exacerbations of Chronic Obstructive Pulmonary Disease; COPD; respiratory; AECOPD; exacerbation

Outcome Measures

Primary Outcomes (3)

• Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)

  An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.

  During year 1

• Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens

  Bacterial pathogens assessed were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Steptococcus pneumoniae (Sp), Staphylococcus Aureus (Sta), Pseudomonas aeruginosa (Psa), any or other. For each bacteria, the means and CIs were estimated from Negative Binomial model taking into account the follow up time.Estimated exacerbations were presented as mean number of exacerbations/ subject/ year.

  During Year 1

• Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum

  Bacterial pathogens assessed, by culture, were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Streptococcus pneumoniae (Sp), Staphylococcus aureus (Sta), Pseudomonas aeruginosa (Psa), any bacteria or other bacteria. Overall exacerbation rate is the average number of exacerbations for each subject during their time in the study.

  During Year 1

Secondary Outcomes (16)

• Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi

  During Year 1

• Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp

  During Year 1

• Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria

  During Year 1

• Mean Number of Days Between 2 Consecutive AECOPDs

  During Year 1

• Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit

  During Year 1

Study Arms (1)

Cohort

OTHER

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

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

Interventions

Blood sample PROCEDURE

Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.

Cohort

Sputum sample PROCEDURE

Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.

Cohort

Nasopharyngeal swab PROCEDURE

Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.

Cohort

Urine sample PROCEDURE

Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.

Cohort

End tidal breath sample PROCEDURE

Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.

Cohort

Data collection OTHER

Patient interview, diary cards review and questionnaires completion

Cohort

Tests OTHER

Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test

Cohort

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 24607562 BACKGROUND

• 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.

  PMID: 29386298 BACKGROUND

• Budroni S, Taccone M, Stella M, Aprea S, Schiavetti F, Bardelli M, Lambert C, Rondini S, Weynants V, Contorni M, Wilkinson TMA, Brazzoli M, Rossi Paccani S. Cytokine Biomarkers of Exacerbations in Sputum From Patients With Chronic Obstructive Pulmonary Disease: A Prospective Cohort Study. J Infect Dis. 2024 Nov 15;230(5):e1112-e1120. doi: 10.1093/infdis/jiae232.

  PMID: 38836471 DERIVED

• Brettoni C, Muzzi A, Rondini S, Weynants V, Rossi Paccani S. Ex-vivo RNA expression analysis of vaccine candidate genes in COPD sputum samples. Respir Res. 2023 Oct 5;24(1):243. doi: 10.1186/s12931-023-02525-z.

  PMID: 37798723 DERIVED

• 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.

  PMID: 33955798 DERIVED

• 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.

  PMID: 33627095 DERIVED

• 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.

  PMID: 31028495 DERIVED

• 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.

  PMID: 30815467 DERIVED

• 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.

  PMID: 30055608 DERIVED

• 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.

  PMID: 28432209 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Respiration Disorders; Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: June 30, 2011
• Primary Completion: June 27, 2014
• Study Completion: June 27, 2014
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)