Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 3500
- Locations
- 1
- Primary Endpoint
- Frequency of COPD Exacerbation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.
Detailed Description
COPD is a leading cause of morbidity and mortality worldwide. Comorbid diseases are an important factor in the prognosis and functional capabilities of COPD patients. There is a relationship between cardiac comorbidity and COPD exacerbation frequency within COPD patients. The main objective of this study is to compare the rate of moderate-severe COPD exacerbations in patients of all COPD severities with and without cardiovascular diseases. Secondary objectives will characterize the prevalence, severity and incidence over time of comorbidities and explore the relationships between comorbidities and rate of COPD exacerbations, force expiratory volume in 1 second (FEV1) decline and quality of life. This will be a prospective, observational, non-drug interventional, non-randomized study that will be carried out in up to 8 European countries. All patients will be enrolled by GP outpatient clinics and data will be collected over 4 visits (screening \[-3 months\], baseline, 12 months post baseline 24 months post baseline) and, additionally by 6 telephone calls (at 3, 6, 9, 15, 18 and 21 months post baseline). The study population will consist of 3330 evaluable patients with diagnosed COPD of any severity grade with and without comorbidities. Subjective and objective data on pre-defined comorbidities will be collected and analyzed.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Presence and severity of other comorbidities(Up to 24 months post baseline.)
- Spirometry(Up to 24 months post baseline.)
- Healthcare Utilisation(Up to 24 months post baseline.)
- Blood Chemistry(Up to 24 months post baseline.)
- Health status(Up to 24 months post baseline.)
- Dyspnoea(Up to 24 months post baseline.)
- Number of Deaths(up to 24 months post baseline.)
- Electrocardiogram(Up to 24 months post baseline.)
- Bone fractures(Within 12 months prior to baseline and up to 24 months post baseline)