Respiratory DisordersNCT01360398

Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly

A study testing Blood sample, Sputum sample and Nasopharyngeal swab in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Respiratory Disorders
What is being tested?: Blood sample, Sputum sample and Nasopharyngeal swab
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 1 siteUnited Kingdom
Study dates: 30 Jun 2011to 27 Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

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

Conditions: Respiratory Disorders
Being tested: Blood sample, Sputum sample, Nasopharyngeal swab, Urine sample, End tidal breath sample
Keywords: pathogen, Chronic Obstructive Pulmonary Disease, Acute Exacerbations of Chronic Obstructive Pulmonary Disease, COPD, respiratory, AECOPD, exacerbation
Medical subject headings: Respiration Disorders, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sampleProcedure or surgery
Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.
Sputum sampleProcedure or surgery
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.
Nasopharyngeal swabProcedure or surgery
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.
Urine sampleProcedure or surgery
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.
End tidal breath sampleProcedure or surgery
Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.
Data collectionOther
Patient interview, diary cards review and questionnaires completion
TestsOther
Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test

Study groups in NCT01360398
Study group	Role	What they receive
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. Receives: Procedure: Blood sample; Procedure: Sputum sample; Procedure: Nasopharyngeal swab; Procedure: Urine sample; Procedure: End tidal breath sample; Other: Data collection; Other: Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: During Year 1

Secondary outcomes (16)

Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for any bacteria and Hi.
Measured: During Year 1
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Mcat and Sp.
Measured: During Year 1
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Sta, Psa and other bacteria.
Measured: During Year 1
Mean Number of Days Between 2 Consecutive AECOPDs
The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date.
Measured: During Year 1
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
The exacerbations of chronic pulmonary disease tool version 1.0 (EXACT) is a validated self-administered instrument that evaluates the effects of pharmacologic treatment on acute exacerbations of COPD. Analyses of exacerbations in relation to morning or evening EXACT-PRO e-diaries were presented as follows: descriptive statistics on the EXACT daily scores tabulated at enrolment, at any stable and at any, mild, moderate or severe exacerbation visit. EXACT-PRO contains 14 questions with scores ranging from 0 to 4, where 0= best outcome while 4= worse outcome.
Measured: During Year 1
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
The COPD assessment test (CAT) is a validated self-administered instrument designed to provide a simple and reliable measure of health status in COPD patients. Its properties have been shown to be similar to the St George's respiratory questionnaire (SGRQ). The CAT comprises 8 items and has a scoring range of 0-40, 0= most positive answer and 40= most negative answer. In this study, the subjects were to complete the CAT questionnaire every 3 months.
Measured: During Year 1
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
The NEADL assessed (quarterly in the present study) the ease or difficulty in performing extended activities of daily living. The NEADL scale contains 22 items, each measured on a 4-point Likert scale. There are four dimensions: mobility (6 items); kitchen (5 items); domestic (5 items); leisure (6 items). These are summed producing a total score reflecting general functioning. Each of the 22 individual items had 2 possible scores (0 or 1). Therefore, the range of the NEADL score was 0 to 22. Lower scores indicate greater levels of disability while higher scores indicate greater independence.
Measured: During Year 1
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
The EQ-5D is an established measure of generic health outcome that provides a simple descriptive profile and a single index value that can be used in clinical and economic evaluation of healthcare and in population surveys. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 100 (best health state). The negative numbers presented represent a decrease from baseline values and a worsening of health.
Measured: During Year 1
Number of Subjects Receiving Various Health Care Types During AECOPD
AECOPD health care type included: general practitioners (other than the study doctor), pneumologists, other specialists, hospital emergency department, home care nurses, pulmonary rehabilitation programs and/or nutrition advices.
Measured: During Year 1
Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal
Serious adverse events (SAEs) include medical occur-rences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disabil-ity/incapacity.
Measured: During Year 1
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria.
Measured: During Year 1
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus.
Measured: During Year 1
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Mild exacerbations were defined as worsening symptoms of COPD that were self-managed by the patient.
Measured: During Year 1
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Moderate exacerbations were defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics.
Measured: During Year 1
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Severe exacerbations were defined as worsening symptoms of COPD that required treatment with in-patient hospitalisation or home care intervention.
Measured: During Year 1
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
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. AECOPD severity was assessed as: any, mild, moderate and severe. Any = any COPD symptom regardless of severity. Mild = Worsening symptoms of COPD that are self-managed by the patient. Moderate = Worsening symptoms of COPD that require treatment with oral corticosteroids and/or antibiotics. Severe = Worsening symptoms of COPD that require treatment with in-patient hospitalisation or home care intervention.
Measured: During Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 201127 Jun 2014

First posted25 May 2011 (estimated)
Study start30 Jun 2011
Primary completion27 Jun 2014
Study completion27 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Respiratory DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01360398
Sponsor's protocol ID: 114378
Status last verified: Feb 2019
First submitted: 24 May 2011
Last updated: 15 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 24607562
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.
PubMed 29386298
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.
PubMed 38836471
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.
PubMed 37798723
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.
PubMed 33955798
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.
PubMed 33627095
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.
PubMed 31028495
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.
PubMed 30815467
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.
PubMed 30055608
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.
PubMed 28432209

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contribution of Infectious Pathogens to Acute Respiratory Illness in Adults and Elderly
ClinicalTrials.gov ID: NCT01360398
Acronym / sponsor ID: 114378
Conditions: Respiratory Disorders
Keywords: pathogen, Chronic Obstructive Pulmonary Disease, Acute Exacerbations of Chronic Obstructive Pulmonary Disease, COPD, respiratory, AECOPD, exacerbation
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jun 2011 (actual)
Primary completion: 27 Jun 2014 (actual)
Study completion: 27 Jun 2014 (actual)
First posted: 25 May 2011 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cohort	Other	Procedure: Blood sample, Procedure: Sputum sample, Procedure: Nasopharyngeal swab, Procedure: Urine sample, Procedure: End tidal breath sample, Other: Data collection, Other: TestsCOPD male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sampleBlood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.	Procedure or surgery	Cohort
Sputum sampleSputum 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.	Procedure or surgery	Cohort
Nasopharyngeal swabNasopharyngeal 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.	Procedure or surgery	Cohort
Urine sampleUrine 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.	Procedure or surgery	Cohort
End tidal breath sampleBreath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.	Procedure or surgery	Cohort
Data collectionPatient interview, diary cards review and questionnaires completion	Other	Cohort
TestsUrine pregnancy test, chest CT-scan, lung function testing and 6-min walk test	Other	Cohort

Primary outcome

Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
Time frame: During year 1
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.
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Time frame: During Year 1
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.
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Time frame: During Year 1
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.

16 secondary outcomes

Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Time frame: During Year 1
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Time frame: During Year 1
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Time frame: During Year 1
Mean Number of Days Between 2 Consecutive AECOPDs
Time frame: During Year 1
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Time frame: During Year 1
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Time frame: During Year 1
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Time frame: During Year 1
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Time frame: During Year 1
Number of Subjects Receiving Various Health Care Types During AECOPD
Time frame: During Year 1
Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal
Time frame: During Year 1
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Time frame: During Year 1
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Time frame: During Year 1
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Time frame: During Year 1
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Time frame: During Year 1
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Time frame: During Year 1
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
Time frame: During Year 1

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Group	127	105

Primary outcome: Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)

Time frame: During year 1. Mean (95% Confidence Interval). Unit: AECOPD/subject/year

Measure	Total Group n = 127
Value	3.04 (2.63 to 3.50)

Population analysed: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.

Primary outcome: Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens

Time frame: During Year 1. Mean (95% Confidence Interval). Unit: AECOPD/subject/year

Measure	Total Group n = 127
Any	1.59 (1.30 to 1.95)
Hi	1.10 (0.84 to 1.43)
Mcat	0.34 (0.24 to 0.48)
Sp	0.39 (0.27 to 0.58)
Sta	0.16 (0.07 to 0.36)
Psa	0.18 (0.09 to 0.35)
Other	0.01 (0.00 to 0.06)

Primary outcome: Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum

Time frame: During Year 1. Number. Unit: AECOPD/subject

Measure	Total Group n = 127
Any Bacteria	1.48
Hi	1.02
Mcat	0.31
Sp	0.37
Sta	0.14
Psa	0.17
Other Bacteria	0.01

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs during Year 1 of the study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Group	0 of 127 (0%)	0 of 0	0 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24607562Bourne 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.
Background: PubMed 29386298Mayhew 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.
Derived from this study: PubMed 38836471Budroni 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.
Derived from this study: PubMed 37798723Brettoni 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.
Derived from this study: PubMed 33955798Wilkinson 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.
Derived from this study: PubMed 33627095Malvisi 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.
Derived from this study: PubMed 31028495Germovsek 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.
Derived from this study: PubMed 30815467Wilkinson 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.
Derived from this study: PubMed 30055608Williams 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.
Derived from this study: PubMed 28432209Wilkinson 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample, Sputum sample and Nasopharyngeal swab in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) (time frame: During year 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360398, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.