Last updated: 07/11/2022 10:10:06

Infectious pathogens in acute respiratory illness in adults and elderly

GSK study ID
114378
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Contribution of infectious pathogens to acute respiratory illness in adults and elderly
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Mean estimated number of Acute Exacerbation of COPD (AECOPD)

Timeframe: During year 1

Mean estimated number of AECOPD with sputum containing bacterial pathogens

Timeframe: During Year 1

Overall AECOPD exacerbation rate for any and specific bacterial pathogens in sputum

Timeframe: During Year 1

Secondary outcomes:

Number of sputum samples positive for specific pathogens - any bacteria and Hi

Timeframe: During Year 1

Number of sputum samples positive for specific pathogens - Mcat and Sp

Timeframe: During Year 1

Number of sputum samples positive for specific pathogens - Sta, Psa and other bacteria

Timeframe: During Year 1

Mean number of days between 2 consecutive AECOPDs

Timeframe: During Year 1

Change from baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) scores at enrollment and any AECOPD visit

Timeframe: During Year 1

Change from baseline COPD Assessment Test (CAT) scores at enrollment and any AECOPD visit

Timeframe: During Year 1

Change from baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) scores at enrollment and any AECOPD visit

Timeframe: During Year 1

Change from baseline COPD EQ-5D index and Visual Analogue Scale (VAS) scores at enrollment and any AECOPD visit

Timeframe: During Year 1

Number of subjects receiving various health care types during AECOPD

Timeframe: During Year 1

Number of subjects with Serious Adverse Events (SAEs) possibly related/linked to withdrawal

Timeframe: During Year 1

AECOPD rate with overall and specific bacterial pathogens in sputum , by Polymerase Chain Reaction (PCR) assay

Timeframe: During Year 1

AECOPD rate with overall and specific viral pathogens in sputum

Timeframe: During Year 1

Mild-AECOPD rate with overall and specific viral pathogens in sputum

Timeframe: During Year 1

Moderate-AECOPD rate with overall and specific viral pathogens in sputum

Timeframe: During Year 1

Severe-AECOPD rate with overall and specific viral pathogens in sputum

Timeframe: During Year 1

AECOPD rate with overall and specific bacterial pathogens in sputum by severity

Timeframe: During Year 1

Interventions:
  • Procedure/surgery: Blood sample
  • Procedure/surgery: Sputum sample
  • Procedure/surgery: Nasopharyngeal swab
  • Procedure/surgery: Urine sample
  • Procedure/surgery: End tidal breath sample
  • Other: Data collection
  • Other: Tests
  • Enrollment:
    152
    Primary completion date:
    2014-27-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bourne S et al. (2014) Acute exacerbation and respiratory infections in COPD (AERIS): protocol for a prospective, observational cohort study. BMJ Open. 7;4(3):e004546. doi: 10.1136/bmjopen-2013-004546.
    Mayhew D et al. (2018) Longitudinal profiling of the lung microbiome in the AERIS study demonstrates repeatability of bacterial and eosinophilic COPD exacerbations. Thorax. 73(5):422-430. doi: 10.1136/thoraxjnl-2017-210408.
    Wilkinson TMA et al (2019) Drivers of year-to-year variation in exacerbation frequency of COPD: analysis of the AERIS cohort. ERJ Open Res. 5(1). pii: 00248-2018. doi: 10.1183/23120541.00248-2018. eCollection 2019 Feb.
    Malvisi L, Yarraguntla A, Mortier M-C, Osman K, Cleary DW, Sente B, Pascal TG, Weynants V, Clarke SC, Taddei L, Wilkinson TMA, Devaster J-M, Devos N, on behalf of the AERIS Study Group. Impact of Bacterial Strain Acquisition in the Lung of Patients with COPD: the AERIS Study. Infect Dis. 2022;TBD(TBD):TBD. DOI: http://dx.doi.org/ 10.1080/23744235.2022.2092648
    Medical condition
    Respiratory Disorders
    Product
    GSK2231395A
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to June 2014
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 85 years
    Accepts healthy volunteers
    No
    • Subjects who the investigator believes can and will comply with the requirements of the protocol.
    • Written informed consent obtained from the subject.
    • Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders.
    • Subjects having undergone lung surgery.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Southampton, Hampshire, United Kingdom, SO16 6YD
    Status
    Study Complete

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-27-06
    Actual study completion date
    2014-27-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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