Status:
COMPLETED
Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
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 (...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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 Patients diagnosed with cancer during the study will be withdrawn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.
Key Trial Info
Start Date :
November 17 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2015
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT01516528
Start Date
November 17 2011
End Date
June 12 2015
Last Update
September 20 2017
Active Locations (233)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Leuven, Belgium, 3000
2
GSK Investigational Site
Angers, France, 49000
3
GSK Investigational Site
Angers, France, 49100
4
GSK Investigational Site
Angers, France, 49933