Last updated: 04/03/2020 12:40:03
A Multicentre Observational Study with 90-days Follow-up Period to Evaluate Clinical Practice Variability as well as Clinical and Organisational Factors Related to Outcomes for COPD Hospital Admissions in PortugalEvaluateCOPDpt
GSK study ID
204499
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
Trial overview
Official title: A Multicentre Observational Study with 90-days Follow-up Period to Evaluate Clinical Practice Variability as well as Clinical and Organisational Factors Related to Outcomes for COPD Hospital Admissions in Portugal
Trial description: The purpose of this study is to evaluate the Clinical Practice variability and outcomes as well as related organizational factors in patients admitted in portuguese hospitals with a COPD exacerbation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Follow-up
Timeframe: 90 days after hospital discharge
Baseline
Timeframe: At hospital discharge
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
December 2016 to June 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
none
- 1. Male and female, aged ≥ 30 years;
- 2. Patient admitted to hospital for a stay of at least 12 hours due to an acute exacerbation of COPD (as diagnosed by a senior clinician and confirmed at discharge by the clinician lead on the basis of the patient notes);
- 1. Admission diagnosis that is not an exacerbation of COPD (e.g. diagnosis of pneumonia, heart failure and pulmonary embolus) even when the patient has previous COPD diagnosis;
- 2. A patient admitted as a clinical case of COPD exacerbation that is later judged to have another primary diagnostic reason for admission, e.g. the subsequent diagnosis is changed from COPD to heart failure;
Inclusion and exclusion criteria
Inclusion criteria:
- Respiratory infection without consolidation;
- Respiratory insufficiency;
- Bronchitis;
- Bronchoconstriction; AND Diagnosis of COPD; 3. Documented FEV1/FVC ratio of <0.7 in the absence of any other obstructive disease such as asthma or bronchiectasis. 4. Written informed consent for study participation.
1. Male and female, aged ≥ 30 years; 2. Patient admitted to hospital for a stay of at least 12 hours due to an acute exacerbation of COPD (as diagnosed by a senior clinician and confirmed at discharge by the clinician lead on the basis of the patient notes); OR Patient admitted to hospital for a stay of at least 12 hours with a respiratory cause of admission as referred by the discharge report and a history compatible with COPD. This includes one of the following:
Exclusion criteria:
- 1. Admission diagnosis that is not an exacerbation of COPD (e.g. diagnosis of pneumonia, heart failure and pulmonary embolus) even when the patient has previous COPD diagnosis; 2. A patient admitted as a clinical case of COPD exacerbation that is later judged to have another primary diagnostic reason for admission, e.g. the subsequent diagnosis is changed from COPD to heart failure; 3. Any other primary cause of deterioration and hospital admission; 4. Extra-pulmonary diseases as the primary diagnosis for admission that may produce similar symptoms; 5. Participation in a clinical trial or other investigational study with intervention within 30 days before the initiation of the study.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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