Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care - Full Text View

Purpose

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.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive	Procedure: Spirometry


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequency of COPD Exacerbation [ Time Frame: From 15 months pre-baseline to 24 months post-baseline. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
The presence and severity pre-defined cardiovascular diseases.

Secondary Outcome Measures:

Presence and severity of other comorbidities [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
As determined by the modified Medical Research Council (mMRC) scale.
Number of Deaths [ Time Frame: up to 24 months post baseline. ] [ Designated as safety issue: No ]
Patients who die during the study, including the reason for death, where known.
Healthcare Utilisation [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
Number of unscheduled GP contacts and Hospitalisations
Blood Chemistry [ Time Frame: Up to 24 months post baseline. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The number and location of bone fractures.


Enrollment:	3500
Study Start Date:	November 2011
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
All All subjects enrolled in the study	Procedure: Spirometry Assessment of lung function by spirometry

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.

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care outpatients who have a an established clinical history of COPD for a minimum of 12 months.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516528

Show 233 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01516528 History of Changes
Other Study ID Numbers:	115058
Study First Received:	January 12, 2012
Last Updated:	June 2, 2016
Health Authority:	Germany: Ethics Commission Poland: Ethics Committees Spain: Agencia Española del Medicamento y Productos Sanitarios France: Comite de Protection des Personnes SUD OUEST et OUTRE MER II Belgium: Local Medical Ethics Committee Netherlands: Medical Ethics Review Committee (METC) France: Agence Française de Sécurité Sanitaire des Produits de Santé Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2016

Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care (ACCESS)