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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | All subjects enrolled in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometry | Procedure | Assessment of lung function by spirometry |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care outpatients who have a an established clinical history of COPD for a minimum of 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Leuven | 3000 | Belgium | |||
| GSK Investigational Site |
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| 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 |
| Angers |
| 49000 |
| France |
| GSK Investigational Site | Angers | 49100 | France |
| GSK Investigational Site | Angers | 49933 | France |
| GSK Investigational Site | Aumetz | 57710 | France |
| GSK Investigational Site | Béziers | 34500 | France |
| GSK Investigational Site | Blois | 41000 | France |
| GSK Investigational Site | Bono | 56400 | France |
| GSK Investigational Site | Bordeaux | 33200 | France |
| GSK Investigational Site | Bouliac | 33270 | France |
| GSK Investigational Site | Bourg-des-Comptes | 35890 | France |
| GSK Investigational Site | Briollay | 49125 | France |
| GSK Investigational Site | Carbon-Blanc | 33650 | France |
| GSK Investigational Site | Carbonne | 31390 | France |
| GSK Investigational Site | Chatou | 78400 | France |
| GSK Investigational Site | Châtellerault | 86100 | France |
| GSK Investigational Site | Cholet | 49300 | France |
| GSK Investigational Site | Chollet | 49300 | France |
| GSK Investigational Site | Couzeix | 87270 | France |
| GSK Investigational Site | Cugnaux | 31270 | France |
| GSK Investigational Site | Dinard | 35800 | France |
| GSK Investigational Site | Donges | 44480 | France |
| GSK Investigational Site | Franconville | 95130 | France |
| GSK Investigational Site | Gémozac | 17260 | France |
| GSK Investigational Site | Grandchamps | 56390 | France |
| GSK Investigational Site | Haute-Goulaine | 44115 | France |
| GSK Investigational Site | Houilles | 78800 | France |
| GSK Investigational Site | La Baule-Escoublac | 44500 | France |
| GSK Investigational Site | La Bouëxière | 35340 | France |
| GSK Investigational Site | La Fôret Sur Sèvres | 79380 | France |
| GSK Investigational Site | La Fresnais | 35111 | France |
| GSK Investigational Site | La Jubaudière | 49510 | France |
| GSK Investigational Site | La Montagne | 44620 | France |
| GSK Investigational Site | La Riche | 37250 | France |
| GSK Investigational Site | La Rochelle | 17000 | France |
| GSK Investigational Site | La Teste-de-Buch | 33260 | France |
| GSK Investigational Site | La Varenne | 49270 | France |
| GSK Investigational Site | Le Fousseret | 31430 | France |
| GSK Investigational Site | Le Mesnil-en-Vallée | 49410 | France |
| GSK Investigational Site | Les Ponts-de-Cé | 49130 | France |
| GSK Investigational Site | Liffré | 35340 | France |
| GSK Investigational Site | Limoges | 87000 | France |
| GSK Investigational Site | Limoges | 87100 | France |
| GSK Investigational Site | Louvigné-de-Bais | 35680 | France |
| GSK Investigational Site | Marseille | 13009 | France |
| GSK Investigational Site | Martin-Église | 76370 | France |
| GSK Investigational Site | Montreuil-Juigné | 49460 | France |
| GSK Investigational Site | Montrevault | 49110 | France |
| GSK Investigational Site | Mouliherne | 49390 | France |
| GSK Investigational Site | Moulins-lès-Metz | 57160 | France |
| GSK Investigational Site | Muret | 31600 | France |
| GSK Investigational Site | Mûrs-Erigné | 49610 | France |
| GSK Investigational Site | Nantes | 44000 | France |
| GSK Investigational Site | Nantes | 44300 | France |
| GSK Investigational Site | Nexon | 87800 | France |
| GSK Investigational Site | Nieul-sur-Mer | 17137 | France |
| GSK Investigational Site | Parçay-les-Pins | 49390 | France |
| GSK Investigational Site | Paris | 75011 | France |
| GSK Investigational Site | Paris | 75013 | France |
| GSK Investigational Site | Paris | 75019 | France |
| GSK Investigational Site | Paris | 75020 | France |
| GSK Investigational Site | Périgny | 17180 | France |
| GSK Investigational Site | Pont-à-Mousson | 54700 | France |
| GSK Investigational Site | Rennes | 35000 | France |
| GSK Investigational Site | Rosiers-d'Égletons | 19300 | France |
| GSK Investigational Site | Royan | 17200 | France |
| GSK Investigational Site | Saint-Aubin-des-Châteaux | 44110 | France |
| GSK Investigational Site | Saint-Cyr-sur-Loire | 37540 | France |
| GSK Investigational Site | Saint-Etienne | 42100 | France |
| GSK Investigational Site | Saint-Étienne-de-Montluc | 44360 | France |
| GSK Investigational Site | Saint-Georges-de-Montaigu | 85600 | France |
| GSK Investigational Site | Saint-Herblain | 44800 | France |
| GSK Investigational Site | Saint-Jouan-des-Guérets | 35430 | France |
| GSK Investigational Site | Saint-Loubès | 33450 | France |
| GSK Investigational Site | Saint-Max | 54130 | France |
| GSK Investigational Site | Saint-Médard-en-Jalles | 33160 | France |
| GSK Investigational Site | Saint-Orens-de-Gameville | 31650 | France |
| GSK Investigational Site | Saint-Pierre-en-Val | 76260 | France |
| GSK Investigational Site | Sarrebourg | 57400 | France |
| GSK Investigational Site | Savonnières | 37510 | France |
| GSK Investigational Site | Scorbé-Clairvaux | 86140 | France |
| GSK Investigational Site | Segré | 49500 | France |
| GSK Investigational Site | Seysses | 31600 | France |
| GSK Investigational Site | St-Malo | 35400 | France |
| GSK Investigational Site | Thionville | 57100 | France |
| GSK Investigational Site | Thouars | 79100 | France |
| GSK Investigational Site | Tiercé | 49125 | France |
| GSK Investigational Site | Toulouse | 31200 | France |
| GSK Investigational Site | Tours | 37000 | France |
| GSK Investigational Site | Tours | 37100 | France |
| GSK Investigational Site | Vannes | 56000 | France |
| GSK Investigational Site | Verzy | 51380 | France |
| GSK Investigational Site | Vihiers | 49310 | France |
| GSK Investigational Site | Villey-Saint-Étienne | 54200 | France |
| GSK Investigational Site | Vitré | 35500 | France |
| GSK Investigational Site | Vue | 44640 | France |
| GSK Investigational Site | Witry-lès-Reims | 51420 | France |
| GSK Investigational Site | Yerres | 91330 | France |
| GSK Investigational Site | Bruchsal | Baden-Wurttemberg | 76646 | Germany |
| GSK Investigational Site | Ettlingen | Baden-Wurttemberg | 76275 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68161 | Germany |
| GSK Investigational Site | Messkirch | Baden-Wurttemberg | 88605 | Germany |
| GSK Investigational Site | Sinsheim | Baden-Wurttemberg | 74889 | Germany |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Bad Woerrishofen | Bavaria | 86825 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80335 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14469 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14478 | Germany |
| GSK Investigational Site | Bensheim | Hesse | 64625 | Germany |
| GSK Investigational Site | Flörsheim | Hesse | 65439 | Germany |
| GSK Investigational Site | Kelkheim | Hesse | 65779 | Germany |
| GSK Investigational Site | Neu-Isenburg | Hesse | 63263 | Germany |
| GSK Investigational Site | Offenbach | Hesse | 63071 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Wardenburg | Lower Saxony | 26203 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53119 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Düren | North Rhine-Westphalia | 52349 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Hagen | North Rhine-Westphalia | 58095 | Germany |
| GSK Investigational Site | Harsewinkel | North Rhine-Westphalia | 33428 | Germany |
| GSK Investigational Site | Rheine | North Rhine-Westphalia | 48431 | Germany |
| GSK Investigational Site | Solingen | North Rhine-Westphalia | 42651 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58452 | Germany |
| GSK Investigational Site | Ingelheim | Rhineland-Palatinate | 55218 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55128 | Germany |
| GSK Investigational Site | Nußbach | Rhineland-Palatinate | 67759 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01069 | Germany |
| GSK Investigational Site | Riesa | Saxony | 01587 | Germany |
| GSK Investigational Site | Köthen | Saxony-Anhalt | 06366 | Germany |
| GSK Investigational Site | Zerbst | Saxony-Anhalt | 39261 | Germany |
| GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23554 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23562 | Germany |
| GSK Investigational Site | Reinfeld | Schleswig-Holstein | 23858 | Germany |
| GSK Investigational Site | Berlin | 10555 | Germany |
| GSK Investigational Site | Berlin | 14052 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | 's-Hertogenbosch | 5235 KG | Netherlands |
| GSK Investigational Site | Andijk | 1619XK | Netherlands |
| GSK Investigational Site | Beek en Donk | 5741 CG | Netherlands |
| GSK Investigational Site | Deurne | 5751 XJ | Netherlands |
| GSK Investigational Site | Eersel | 5521 WD | Netherlands |
| GSK Investigational Site | Enschede | 7544 BA | Netherlands |
| GSK Investigational Site | Ermelo | 3851 EX | Netherlands |
| GSK Investigational Site | Hoogwoud | 1718 BG | Netherlands |
| GSK Investigational Site | Kloosterhaar | 7694 AC | Netherlands |
| GSK Investigational Site | Lieshout | 5737 CB | Netherlands |
| GSK Investigational Site | Musselkanaal | 9581 AJ | Netherlands |
| GSK Investigational Site | Nijverdal | 7442 LS | Netherlands |
| GSK Investigational Site | Soerendonk | 6027 PL | Netherlands |
| GSK Investigational Site | Spijkenisse | 3207 NB | Netherlands |
| GSK Investigational Site | The Hague | 2517 EW | Netherlands |
| GSK Investigational Site | The Hague | 2582 LJ | Netherlands |
| GSK Investigational Site | Voerendaal | 6367 ED | Netherlands |
| GSK Investigational Site | Wildervank | 9648 BE | Netherlands |
| GSK Investigational Site | Zaandam | 1504 JA | Netherlands |
| GSK Investigational Site | Zwijndrecht | 3334 CL | Netherlands |
| GSK Investigational Site | Bydgoszcz | 85-046 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-796 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-863 | Poland |
| GSK Investigational Site | Częstochowa | 42-200 | Poland |
| GSK Investigational Site | Domaradz | 36-230 | Poland |
| GSK Investigational Site | Elblag | 82-300 | Poland |
| GSK Investigational Site | Jasło | 38-200 | Poland |
| GSK Investigational Site | Katowice | 40-055 | Poland |
| GSK Investigational Site | Katowice | 40-645 | Poland |
| GSK Investigational Site | Katowice | 40-750 | Poland |
| GSK Investigational Site | Katowice | 40-954 | Poland |
| GSK Investigational Site | Krakow | 30-015 | Poland |
| GSK Investigational Site | Krakow | 30-053 | Poland |
| GSK Investigational Site | Krakow | 30-347 | Poland |
| GSK Investigational Site | Krakow | 31-637 | Poland |
| GSK Investigational Site | Libiąż | 32-590 | Poland |
| GSK Investigational Site | Lodz | 90-265 | Poland |
| GSK Investigational Site | Lublin | 20-854 | Poland |
| GSK Investigational Site | Mielec | 39-300 | Poland |
| GSK Investigational Site | Oświęcim | 32-600 | Poland |
| GSK Investigational Site | Puławy | 24-100 | Poland |
| GSK Investigational Site | Radom | Poland |
| GSK Investigational Site | Radziszów | 32-052 | Poland |
| GSK Investigational Site | Rzeszów | 35-055 | Poland |
| GSK Investigational Site | Rzeszów | 35-068 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Torun | 87-100 | Poland |
| GSK Investigational Site | Warsaw | 01-231 | Poland |
| GSK Investigational Site | Warsaw | 01-868 | Poland |
| GSK Investigational Site | Wroclaw | 50-127 | Poland |
| GSK Investigational Site | Wroclaw | 50-349 | Poland |
| GSK Investigational Site | Zabrze | 41-800 | Poland |
| GSK Investigational Site | Zgierz | 95-100 | Poland |
| GSK Investigational Site | Zgłobień | 36-046 | Poland |
| GSK Investigational Site | A Coruña | 15008 | Spain |
| GSK Investigational Site | Algeciras | 11205 | Spain |
| GSK Investigational Site | Alicante | 03005 | Spain |
| GSK Investigational Site | Barakaldo | 48903 | Spain |
| GSK Investigational Site | Barcelona | 08018 | Spain |
| GSK Investigational Site | Barcelona | 08023 | Spain |
| GSK Investigational Site | Barcelona | 08028 | Spain |
| GSK Investigational Site | Barcelona | 08033 | Spain |
| GSK Investigational Site | Barcelona | 08034 | Spain |
| GSK Investigational Site | Barcelona | 08041 | Spain |
| GSK Investigational Site | Barcelona | 8025 | Spain |
| GSK Investigational Site | Benidor / Alicante | 03503 | Spain |
| GSK Investigational Site | Canet de Mar - Barcelona | 08360 | Spain |
| GSK Investigational Site | Colloto - Oviedo | 33010 | Spain |
| GSK Investigational Site | Cornellá de Llobregat-Barcelona | 08940 | Spain |
| GSK Investigational Site | Culleredo - La Coruña | 15670 | Spain |
| GSK Investigational Site | El Puerto de Santa María-Cádiz | 11500 | Spain |
| GSK Investigational Site | Fuenlabrada / Madrid | 28943 | Spain |
| GSK Investigational Site | Gijón | 33211 | Spain |
| GSK Investigational Site | Gijón | 33212 | Spain |
| GSK Investigational Site | Gijón. Asturias. | 33213 | Spain |
| GSK Investigational Site | Güeñes - Vizcaya | 48830 | Spain |
| GSK Investigational Site | Hostalric - Gerona | 17450 | Spain |
| GSK Investigational Site | La Roca Del Valles (Barcelona) | 08430 | Spain |
| GSK Investigational Site | Les Franqueses Del Vallés - Barcelona | 08530 | Spain |
| GSK Investigational Site | Madrid | 28700 | Spain |
| GSK Investigational Site | Mataró | 08303 | Spain |
| GSK Investigational Site | Mataró. Barcelona. | 08302 | Spain |
| GSK Investigational Site | Málaga | 29014 | Spain |
| GSK Investigational Site | Murcia | 30010 | Spain |
| GSK Investigational Site | Oviedo | 33009 | Spain |
| GSK Investigational Site | Oviedo | Spain |
| GSK Investigational Site | Peralada( Girona) | 17491 | Spain |
| GSK Investigational Site | Petrer/Alicante | 03610 | Spain |
| GSK Investigational Site | Portugalete - Vizcaya | 48920 | Spain |
| GSK Investigational Site | San Juan | Spain |
| GSK Investigational Site | Santa Coloma de Gramanet - Barcelona | 08924 | Spain |
| GSK Investigational Site | Valencia | 46021 | Spain |
| GSK Investigational Site | Valencia | Spain |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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