Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care (ACCESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516528
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|