Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care (ACCESS)
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ClinicalTrials.gov Identifier: NCT01516528 |
Recruitment Status
:
Completed
First Posted
: January 25, 2012
Last Update Posted
: September 20, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Pulmonary Disease, Chronic Obstructive | Procedure: Spirometry |
Study Type : | Observational |
Actual Enrollment : | 3500 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Group/Cohort | Intervention/treatment |
---|---|
All
All subjects enrolled in the study
|
Procedure: Spirometry
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.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male or female patients aged ≥ 40 years
- An established clinical history of COPD for a minimum of 12 months, of any severity.
- FEV1/FVC post-bronchodilator ratio < 0.70 (within the last 12 months, or confirmed at the screening visit [or 4 weeks after the screening visit if patient's COPD is not stable]).
- Current or ex-smokers with a smoking history of at least 10 pack-years
- A signed and dated written informed consent is obtained prior to participation
Exclusion Criteria:
- In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included)
- A diagnosis of fibrosis or asbestosis
- Diagnosis of cancer - current or within the last 5 years (patients in remission for ≥ 5 years may be included). Patients diagnosed with cancer during the study will be withdrawn
- Diagnosis of clinically significant bronchiectasis
- Subjects who are concurrently participating in any clinical study or who have received any investigational drugs within 4 weeks of baseline, or who will start any during the study period.
- Unable to or unwilling to conform with the study requirements including completion of the health status questionnaires
- Females who are pregnant or lactating.

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 |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01516528 History of Changes |
Other Study ID Numbers: |
115058 |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | September 20, 2017 |
Last Verified: | September 2017 |
Keywords provided by GlaxoSmithKline:
COPD exacerbation comorbidities lung function burden |
chronic bronchitis emphysema prevalence cardiovascular disease |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Chronic Disease |
Respiratory Tract Diseases Disease Attributes Pathologic Processes |