Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care (ACCESS)
|ClinicalTrials.gov Identifier: NCT01516528|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Procedure: Spirometry|
|Study Type :||Observational|
|Actual Enrollment :||3500 participants|
|Official Title:||Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care|
|Study Start Date :||November 17, 2011|
|Actual Primary Completion Date :||May 1, 2015|
|Actual Study Completion Date :||June 12, 2015|
All subjects enrolled in the study
Assessment of lung function by spirometry
- Frequency of COPD Exacerbation [ Time Frame: From 15 months pre-baseline to 24 months post-baseline. ]COPD exacerbations (moderate-severe severity), defined as a worsening of symptoms that require oral corticosteroids or antibiotics or hospitalization, or any combination of these.
- Presence and severity of cardiovascular disease. [ Time Frame: From 3 months pre-baseline to 24 months post-baseline. ]The presence and severity pre-defined cardiovascular diseases.
- Presence and severity of other comorbidities [ Time Frame: Up to 24 months post baseline. ]The presence and severity of pre-defined comorbidities (depression/anxiety, diabetes with and without target organ disease, sleep apnoea syndrome, gastroesophageal reflux, hypercholesterolemia, osteoarthritis, osteoporosis, inflammatory bowel disease, peptic ulcer, other treated comorbidities) .
- Spirometry [ Time Frame: Up to 24 months post baseline. ]Post-bronchodilator FEV1 and forced vital capacity (FVC), FEV1/FVC ratio and FEV1 % of predicted.
- Health status [ Time Frame: Up to 24 months post baseline. ]As determined by COPD Assessment Test (CAT), EuroQOL Five Dimensions Questionnaire (EQ-5D), Hospital Anxiety Depression Scale (HADS) and Epworth Sleepiness Scale (ESS), Frequency Scale for the Symptoms of Gastro-oesophageal reflux disease (FSSG).
- Dyspnoea [ Time Frame: Up to 24 months post baseline. ]As determined by the modified Medical Research Council (mMRC) scale.
- Number of Deaths [ Time Frame: up to 24 months post baseline. ]Patients who die during the study, including the reason for death, where known.
- Healthcare Utilisation [ Time Frame: Up to 24 months post baseline. ]Number of unscheduled GP contacts and Hospitalisations
- Blood Chemistry [ Time Frame: Up to 24 months post baseline. ]Including glucose; Haemoglobin A1C (HbA1c); low density lipoprotein (LDL-c), High density lipoprotein (HDL-c), Total cholesterol; triglycerides, prohormone natriuretic peptide (pro-BNP); high-sensitivity C reactive protein (hs-CRP); protein; full blood count
- Electrocardiogram [ Time Frame: Up to 24 months post baseline. ]Assessment of normal or abnormal readings. Qualitative description and QT interval.
- Bone fractures [ Time Frame: Within 12 months prior to baseline and up to 24 months post baseline ]The number and location of bone fractures.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516528
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|