Infectious pathogens in acute respiratory illness in adults and elderly
Trial overview
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
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
- 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.
- 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.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
- 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.
Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.