N/A
N=127
Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly
Respiratory Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01360398 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) — 3.04 AECOPD/subject/year
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sample (Procedure); Sputum sample (Procedure); Nasopharyngeal swab (Procedure); Urine sample (Procedure); End tidal breath sample (Procedure); Data collection (Other); Tests (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) |
3.04 | — |
| PRIMARY Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens |
1.59; 1.10; 0.34; 0.39; 0.16; 0.18 | — |
| PRIMARY Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum |
1.48; 1.02; 0.31; 0.37; 0.14; 0.17 | — |
| SECONDARY Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi |
57; 466; 188; 17; 162; 9 | — |
| SECONDARY Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp |
8; 50; 40; 1; 39; 0 | — |
| SECONDARY Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria |
6; 40; 18; 0; 18; 0 | — |
| SECONDARY Mean Number of Days Between 2 Consecutive AECOPDs |
55.5 | — |
| SECONDARY Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit |
0.0; -3.0; 2.7; 0.3; 2.9; 2.3 | — |
| SECONDARY Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit |
0.0; -0.9; 4.1; 0.3; 4.3; 7.2 | — |
| SECONDARY Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit |
0.0; 6.2; 3.2; 3.8; 3.3; 0 | — |
| SECONDARY Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit |
0.0; -1.4; -14.8; -4.3; -15.8; -16.9 | — |
| SECONDARY Number of Subjects Receiving Various Health Care Types During AECOPD |
82; 26; 104; 4; 103; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal |
— | — |
| SECONDARY AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay |
1.61; 1.30; 0.47; 0.20; 0.09; 0.14 | — |
| SECONDARY AECOPD Rate With Overall and Specific Viral Pathogens in Sputum |
0.99; 0.02; 0.05; 0.63; 0.05; 0.06 | — |
| SECONDARY Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum |
0.08; 0.00; 0.02; 0.05; 0.00; 0.00 | — |
| SECONDARY Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum |
0.85; 0.02; 0.03; 0.54; 0.04; 0.06 | — |
| SECONDARY Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum |
0.06; 0.00; 0.00; 0.04; 0.01; 0.01 | — |
| SECONDARY AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity |
1.48; 0.13; 1.28; 0.07 | — |
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 /=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.
Data sourced from ClinicalTrials.gov (NCT01360398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.