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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 3500

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • GSK Investigational Site
• France
  • Angers, France, 49100
    • GSK Investigational Site
  • Angers, France, 49000
    • GSK Investigational Site
  • Angers cedex 9, France, 49933
    • GSK Investigational Site
  • Aumetz, France, 57710
    • GSK Investigational Site
  • Beziers, France, 34500
    • GSK Investigational Site
  • Blois, France, 41000
    • GSK Investigational Site
  • Bordeaux, France, 33200
    • GSK Investigational Site
  • Bouliac, France, 33270
    • GSK Investigational Site
  • Bourg Des Comptes, France, 35890
    • GSK Investigational Site
  • Briollay, France, 49125
    • GSK Investigational Site
  • Carbon Blanc, France, 33650
    • GSK Investigational Site
  • Carbonne, France, 31390
    • GSK Investigational Site
  • Chatellerault, France, 86100
    • GSK Investigational Site
  • Chatou, France, 78400
    • GSK Investigational Site
  • Cholet, France, 49300
    • GSK Investigational Site
  • Chollet, France, 49300
    • GSK Investigational Site
  • Couzeix, France, 87270
    • GSK Investigational Site
  • Cugnaux, France, 31270
    • GSK Investigational Site
  • Dinard, France, 35800
    • GSK Investigational Site
  • Donges, France, 44480
    • GSK Investigational Site
  • Escoublac, France, 44500
    • GSK Investigational Site
  • Franconville, France, 95130
    • GSK Investigational Site
  • Gemozac, France, 17260
    • GSK Investigational Site
  • Grandchamps, France, 56390
    • GSK Investigational Site
  • Haute Goulaine, France, 44115
    • GSK Investigational Site
  • Houilles, France, 78800
    • GSK Investigational Site
  • La Bouexiere, France, 35340
    • GSK Investigational Site
  • La Fresnais, France, 35111
    • GSK Investigational Site
  • La Fôret sur Sèvres, France, 79380
    • GSK Investigational Site
  • La Jubaudière, France, 49510
    • GSK Investigational Site
  • La Montagne, France, 44620
    • GSK Investigational Site
  • La Riche, France, 37250
    • GSK Investigational Site
  • La Rochelle, France, 17000
    • GSK Investigational Site
  • La Teste de Buch, France, 33260
    • GSK Investigational Site
  • La Varenne, France, 49270
    • GSK Investigational Site
  • Le Bono, France, 56400
    • GSK Investigational Site
  • Le Fousseret, France, 31430
    • GSK Investigational Site
  • Le Mesnil en Vallée, France, 49410
    • GSK Investigational Site
  • Les Ponts de Cé, France, 49130
    • GSK Investigational Site
  • Liffre, France, 35340
    • GSK Investigational Site
  • Limoges, France, 87000
    • GSK Investigational Site
  • Limoges, France, 87100
    • GSK Investigational Site
  • Louvigne de Bais, France, 35680
    • GSK Investigational Site
  • Marseille, France, 13009
    • GSK Investigational Site
  • Martin Eglise, France, 76370
    • GSK Investigational Site
  • Montreuil Juigne, France, 49460
    • GSK Investigational Site
  • Montrevault, France, 49110
    • GSK Investigational Site
  • Mouliherne, France, 49390
    • GSK Investigational Site
  • Moulins les Metz, France, 57160
    • GSK Investigational Site
  • Muret, France, 31600
    • GSK Investigational Site
  • Murs-Erigne, France, 49610
    • GSK Investigational Site
  • Nantes, France, 44300
    • GSK Investigational Site
  • Nantes, France, 44000
    • GSK Investigational Site
  • Nexon, France, 87800
    • GSK Investigational Site
  • Nieul sur Mer, France, 17137
    • GSK Investigational Site
  • Parcay les Pins, France, 49390
    • GSK Investigational Site
  • Paris, France, 75013
    • GSK Investigational Site
  • Paris, France, 75020
    • GSK Investigational Site
  • Paris, France, 75011
    • GSK Investigational Site
  • Paris, France, 75019
    • GSK Investigational Site
  • Perigny, France, 17180
    • GSK Investigational Site
  • Pont à Mousson, France, 54700
    • GSK Investigational Site
  • Rennes, France, 35000
    • GSK Investigational Site
  • Rosiers d'Egletons, France, 19300
    • GSK Investigational Site
  • Royan, France, 17200
    • GSK Investigational Site
  • Saint Aubin des Chateaux, France, 44110
    • GSK Investigational Site
  • Saint Cyr sur Loire, France, 37540
    • GSK Investigational Site
  • Saint Etienne de Montluc, France, 44360
    • GSK Investigational Site
  • Saint Georges de Montaigu, France, 85600
    • GSK Investigational Site
  • Saint Herblain, France, 44800
    • GSK Investigational Site
  • Saint Jouan des Guerets, France, 35430
    • GSK Investigational Site
  • Saint Malo, France, 35400
    • GSK Investigational Site
  • Saint Max, France, 54130
    • GSK Investigational Site
  • Saint Médard en Jalles, France, 33160
    • GSK Investigational Site
  • Saint Orens de Gameville, France, 31650
    • GSK Investigational Site
  • Saint Pierre en Val, France, 76260
    • GSK Investigational Site
  • Saint-Etienne, France, 42100
    • GSK Investigational Site
  • Saint-Loubès, France, 33450
    • GSK Investigational Site
  • Sarrebourg, France, 57400
    • GSK Investigational Site
  • Savonnières, France, 37510
    • GSK Investigational Site
  • Scorbe Clairvaux, France, 86140
    • GSK Investigational Site
  • Segré, France, 49500
    • GSK Investigational Site
  • Seysses, France, 31600
    • GSK Investigational Site
  • Thionville, France, 57100
    • GSK Investigational Site
  • Thouars, France, 79100
    • GSK Investigational Site
  • Tierce, France, 49125
    • GSK Investigational Site
  • Toulouse, France, 31200
    • GSK Investigational Site
  • Tours, France, 37000
    • GSK Investigational Site
  • Tours, France, 37100
    • GSK Investigational Site
  • Vannes, France, 56000
    • GSK Investigational Site
  • Verzy, France, 51380
    • GSK Investigational Site
  • Vihiers, France, 49310
    • GSK Investigational Site
  • Villey Saint Etienne, France, 54200
    • GSK Investigational Site
  • Vitré, France, 35500
    • GSK Investigational Site
  • Vue, France, 44640
    • GSK Investigational Site
  • Witry les Reims, France, 51420
    • GSK Investigational Site
  • Yerres, France, 91330
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 14052
    • GSK Investigational Site
  • Berlin, Germany, 10555
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Bruchsal, Baden-Wuerttemberg, Germany, 76646
      • GSK Investigational Site
    • Ettlingen, Baden-Wuerttemberg, Germany, 76275
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68161
      • GSK Investigational Site
    • Messkirch, Baden-Wuerttemberg, Germany, 88605
      • GSK Investigational Site
    • Sinsheim, Baden-Wuerttemberg, Germany, 74889
      • GSK Investigational Site
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site
  • Bayern
    • Bad Woerrishofen, Bayern, Germany, 86825
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80335
      • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14469
      • GSK Investigational Site
    • Potsdam, Brandenburg, Germany, 14478
      • GSK Investigational Site
  • Hessen
    • Bensheim, Hessen, Germany, 64625
      • GSK Investigational Site
    • Floersheim, Hessen, Germany, 65439
      • GSK Investigational Site
    • Kelkheim, Hessen, Germany, 65779
      • GSK Investigational Site
    • Neu-Isenburg, Hessen, Germany, 63263
      • GSK Investigational Site
    • Offenbach, Hessen, Germany, 63071
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • GSK Investigational Site
    • Wardenburg, Niedersachsen, Germany, 26203
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53119
      • GSK Investigational Site
    • Dueren, Nordrhein-Westfalen, Germany, 52349
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
    • Goch, Nordrhein-Westfalen, Germany, 47574
      • GSK Investigational Site
    • Hagen, Nordrhein-Westfalen, Germany, 58095
      • GSK Investigational Site
    • Harsewinkel, Nordrhein-Westfalen, Germany, 33428
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 51069
      • GSK Investigational Site
    • Rheine, Nordrhein-Westfalen, Germany, 48431
      • GSK Investigational Site
    • Solingen, Nordrhein-Westfalen, Germany, 42651
      • GSK Investigational Site
    • Witten, Nordrhein-Westfalen, Germany, 58452
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Ingelheim, Rheinland-Pfalz, Germany, 55218
      • GSK Investigational Site
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
    • Mainz, Rheinland-Pfalz, Germany, 55128
      • GSK Investigational Site
    • Nussbach, Rheinland-Pfalz, Germany, 67759
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • GSK Investigational Site
    • Riesa, Sachsen, Germany, 01587
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Koethen, Sachsen-Anhalt, Germany, 06366
      • GSK Investigational Site
    • Zerbst, Sachsen-Anhalt, Germany, 39261
      • GSK Investigational Site
  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany, 23795
      • GSK Investigational Site
    • Luebeck, Schleswig-Holstein, Germany, 23554
      • GSK Investigational Site
    • Luebeck, Schleswig-Holstein, Germany, 23562
      • GSK Investigational Site
    • Reinfeld, Schleswig-Holstein, Germany, 23858
      • GSK Investigational Site
• Netherlands
  • Andijk, Netherlands, 1619XK
    • GSK Investigational Site
  • Beek En Donk, Netherlands, 5741 CG
    • GSK Investigational Site
  • Den Bosch, Netherlands, 5235 KG
    • GSK Investigational Site
  • Den Haag, Netherlands, 2582 LJ
    • GSK Investigational Site
  • Den Haag, Netherlands, 2517 EW
    • GSK Investigational Site
  • Deurne, Netherlands, 5751 XJ
    • GSK Investigational Site
  • Eersel, Netherlands, 5521 WD
    • GSK Investigational Site
  • Enschede, Netherlands, 7544 BA
    • GSK Investigational Site
  • Ermelo, Netherlands, 3851 EX
    • GSK Investigational Site
  • Hoogwoud, Netherlands, 1718 BG
    • GSK Investigational Site
  • Kloosterhaar, Netherlands, 7694 AC
    • GSK Investigational Site
  • Lieshout, Netherlands, 5737 CB
    • GSK Investigational Site
  • Musselkanaal, Netherlands, 9581 AJ
    • GSK Investigational Site
  • Nijverdal, Netherlands, 7442 LS
    • GSK Investigational Site
  • Soerendonk, Netherlands, 6027 PL
    • GSK Investigational Site
  • Spijkenisse, Netherlands, 3207 NB
    • GSK Investigational Site
  • Voerendaal, Netherlands, 6367 ED
    • GSK Investigational Site
  • Wildervank, Netherlands, 9648 BE
    • GSK Investigational Site
  • Zaandam, Netherlands, 1504 JA
    • GSK Investigational Site
  • Zwijndrecht, Netherlands, 3334 CL
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-046
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-863
    • GSK Investigational Site
  • Czestochowa, Poland, 42-200
    • GSK Investigational Site
  • Domaradz, Poland, 36-230
    • GSK Investigational Site
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Jaslo, Poland, 38-200
    • GSK Investigational Site
  • Katowice, Poland, 40-645
    • GSK Investigational Site
  • Katowice, Poland, 40-055
    • GSK Investigational Site
  • Katowice, Poland, 40-750
    • GSK Investigational Site
  • Katowice, Poland, 40-954
    • GSK Investigational Site
  • Krakow, Poland, 30-015
    • GSK Investigational Site
  • Krakow, Poland, 30-053
    • GSK Investigational Site
  • Krakow, Poland, 30-347
    • GSK Investigational Site
  • Krakow, Poland, 31-637
    • GSK Investigational Site
  • Libiaz, Poland, 32-590
    • GSK Investigational Site
  • Lodz, Poland, 90-265
    • GSK Investigational Site
  • Lublin, Poland, 20-854
    • GSK Investigational Site
  • Mielec, Poland, 39-300
    • GSK Investigational Site
  • Oswiecim, Poland, 32-600
    • GSK Investigational Site
  • Pulawy, Poland, 24-100
    • GSK Investigational Site
  • Radom, Poland
    • GSK Investigational Site
  • Radziszow, Poland, 32-052
    • GSK Investigational Site
  • Rzeszow, Poland, 35-055
    • GSK Investigational Site
  • Rzeszow, Poland, 35-068
    • GSK Investigational Site
  • Tarnow, Poland, 33-100
    • GSK Investigational Site
  • Torun, Poland, 87-100
    • GSK Investigational Site
  • Warszawa, Poland, 01-868
    • GSK Investigational Site
  • Warszawa, Poland, 01-231
    • GSK Investigational Site
  • Wroclaw, Poland, 50-349
    • GSK Investigational Site
  • Wroclaw, Poland, 50-127
    • GSK Investigational Site
  • Zabrze, Poland, 41-800
    • GSK Investigational Site
  • Zgierz, Poland, 95-100
    • GSK Investigational Site
  • Zglobien, Poland, 36-046
    • GSK Investigational Site
• Spain
  • Algeciras, Spain, 11205
    • GSK Investigational Site
  • Alicante, Spain, 03005
    • GSK Investigational Site
  • Baracaldo, Spain, 48903
    • GSK Investigational Site
  • Barcelona, Spain, 08041
    • GSK Investigational Site
  • Barcelona, Spain, 8025
    • GSK Investigational Site
  • Barcelona, Spain, 08023
    • GSK Investigational Site
  • Barcelona, Spain, 08028
    • GSK Investigational Site
  • Barcelona, Spain, 08018
    • GSK Investigational Site
  • Barcelona, Spain, 08033
    • GSK Investigational Site
  • Barcelona, Spain, 08034
    • GSK Investigational Site
  • Benidor / Alicante, Spain, 03503
    • GSK Investigational Site
  • Canet de Mar - Barcelona, Spain, 08360
    • GSK Investigational Site
  • Colloto - Oviedo, Spain, 33010
    • GSK Investigational Site
  • Cornellá de Llobregat-Barcelona, Spain, 08940
    • GSK Investigational Site
  • Culleredo - La Coruña, Spain, 15670
    • GSK Investigational Site
  • El Puerto de Santa María-Cádiz, Spain, 11500
    • GSK Investigational Site
  • Fuenlabrada / Madrid, Spain, 28943
    • GSK Investigational Site
  • Gijón, Spain, 33211
    • GSK Investigational Site
  • Gijón, Spain, 33212
    • GSK Investigational Site
  • Gijón. Asturias., Spain, 33213
    • GSK Investigational Site
  • Güeñes - Vizcaya, Spain, 48830
    • GSK Investigational Site
  • Hostalric - Gerona, Spain, 17450
    • GSK Investigational Site
  • La Coruña, Spain, 15008
    • GSK Investigational Site
  • La Roca del Valles (Barcelona), Spain, 08430
    • GSK Investigational Site
  • Les Franqueses del Vallés - Barcelona, Spain, 08530
    • GSK Investigational Site
  • Madrid, Spain, 28700
    • GSK Investigational Site
  • Mataró, Spain, 08303
    • GSK Investigational Site
  • Mataró. Barcelona., Spain, 08302
    • GSK Investigational Site
  • Murcia, Spain, 30010
    • GSK Investigational Site
  • Málaga, Spain, 29014
    • GSK Investigational Site
  • Oviedo, Spain, 33009
    • GSK Investigational Site
  • Oviedo, Spain
    • GSK Investigational Site
  • Petrer/Alicante, Spain, 03610
    • GSK Investigational Site
  • Portugalete - Vizcaya, Spain, 48920
    • GSK Investigational Site
  • San Juan, Spain
    • GSK Investigational Site
  • Santa Coloma de Gramanet - Barcelona, Spain, 08924
    • GSK Investigational Site
  • Valencia, Spain
    • GSK Investigational Site
  • Valencia, Spain, 46021
    • GSK Investigational Site
  • peralada( Girona), Spain, 17491
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All; All subjects enrolled in the study	Procedure: Spirometry; Assessment of lung function by spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of COPD Exacerbation	COPD exacerbations (moderate-severe severity), defined as a worsening of symptoms that require oral corticosteroids or antibiotics or hospitalization, or any combination of these.	From 15 months pre-baseline to 24 months post-baseline.
Presence and severity of cardiovascular disease.	The presence and severity pre-defined cardiovascular diseases.	From 3 months pre-baseline to 24 months post-baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence and severity of other comorbidities	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) .	Up to 24 months post baseline.
Spirometry	Post-bronchodilator FEV1 and forced vital capacity (FVC), FEV1/FVC ratio and FEV1 % of predicted.	Up to 24 months post baseline.
Health status	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).	Up to 24 months post baseline.
Dyspnoea	As determined by the modified Medical Research Council (mMRC) scale.	Up to 24 months post baseline.
Number of Deaths	Patients who die during the study, including the reason for death, where known.	up to 24 months post baseline.
Healthcare Utilisation	Number of unscheduled GP contacts and Hospitalisations	Up to 24 months post baseline.
Blood Chemistry	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	Up to 24 months post baseline.
Electrocardiogram	Assessment of normal or abnormal readings. Qualitative description and QT interval.	Up to 24 months post baseline.
Bone fractures	The number and location of bone fractures.	Within 12 months prior to baseline and up to 24 months post baseline

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 17, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 12, 2015

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: lung function; COPD; exacerbation; comorbidities; cardiovascular disease; prevalence; emphysema; chronic bronchitis; burden
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 115058