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

NCT01516528 | Completed

• 1 other identifier: 115058
• Study Type: observational
• Target: 3,500
• Locations: 6 countries
• Sites: 233

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; exacerbation; comorbidities; lung function; burden; chronic bronchitis; emphysema; prevalence; cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Presence and severity of other comorbidities

  Up to 24 months post baseline.

• Spirometry

  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.

Study Arms (1)

All

All subjects enrolled in the study

Procedure: Spirometry

Interventions

Spirometry PROCEDURE

Assessment of lung function by spirometry

All

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (233)

GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Angers, 49000, France

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GSK Investigational Site

Angers, 49100, France

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GSK Investigational Site

Angers, 49933, France

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GSK Investigational Site

Aumetz, 57710, France

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GSK Investigational Site

Béziers, 34500, France

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GSK Investigational Site

Blois, 41000, France

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GSK Investigational Site

Bono, 56400, France

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GSK Investigational Site

Bordeaux, 33200, France

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GSK Investigational Site

Bouliac, 33270, France

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GSK Investigational Site

Bourg-des-Comptes, 35890, France

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GSK Investigational Site

Briollay, 49125, France

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GSK Investigational Site

Carbon-Blanc, 33650, France

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GSK Investigational Site

Carbonne, 31390, France

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GSK Investigational Site

Chatou, 78400, France

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GSK Investigational Site

Châtellerault, 86100, France

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GSK Investigational Site

Cholet, 49300, France

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GSK Investigational Site

Chollet, 49300, France

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GSK Investigational Site

Couzeix, 87270, France

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Cugnaux, 31270, France

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Dinard, 35800, France

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Donges, 44480, France

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Franconville, 95130, France

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Gémozac, 17260, France

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Grandchamps, 56390, France

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Haute-Goulaine, 44115, France

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Houilles, 78800, France

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GSK Investigational Site

La Baule-Escoublac, 44500, France

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GSK Investigational Site

La Bouëxière, 35340, France

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GSK Investigational Site

La Fôret Sur Sèvres, 79380, France

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GSK Investigational Site

La Fresnais, 35111, France

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GSK Investigational Site

La Jubaudière, 49510, France

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La Montagne, 44620, France

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GSK Investigational Site

La Riche, 37250, France

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La Rochelle, 17000, France

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GSK Investigational Site

La Teste-de-Buch, 33260, France

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La Varenne, 49270, France

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Le Fousseret, 31430, France

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GSK Investigational Site

Le Mesnil-en-Vallée, 49410, France

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Les Ponts-de-Cé, 49130, France

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Liffré, 35340, France

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Limoges, 87000, France

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Limoges, 87100, France

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Louvigné-de-Bais, 35680, France

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Marseille, 13009, France

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Martin-Église, 76370, France

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Montreuil-Juigné, 49460, France

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Montrevault, 49110, France

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Mouliherne, 49390, France

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Moulins-lès-Metz, 57160, France

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Muret, 31600, France

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Mûrs-Erigné, 49610, France

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Nantes, 44000, France

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GSK Investigational Site

Nantes, 44300, France

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Nexon, 87800, France

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Nieul-sur-Mer, 17137, France

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Parçay-les-Pins, 49390, France

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GSK Investigational Site

Paris, 75011, France

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GSK Investigational Site

Paris, 75013, France

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GSK Investigational Site

Paris, 75019, France

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GSK Investigational Site

Paris, 75020, France

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Périgny, 17180, France

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GSK Investigational Site

Pont-à-Mousson, 54700, France

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Rennes, 35000, France

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GSK Investigational Site

Rosiers-d'Égletons, 19300, France

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GSK Investigational Site

Royan, 17200, France

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Saint-Aubin-des-Châteaux, 44110, France

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Saint-Cyr-sur-Loire, 37540, France

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Saint-Etienne, 42100, France

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Saint-Étienne-de-Montluc, 44360, France

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Saint-Georges-de-Montaigu, 85600, France

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Saint-Herblain, 44800, France

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Saint-Jouan-des-Guérets, 35430, France

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Saint-Loubès, 33450, France

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Saint-Max, 54130, France

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Saint-Médard-en-Jalles, 33160, France

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Saint-Orens-de-Gameville, 31650, France

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Saint-Pierre-en-Val, 76260, France

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Sarrebourg, 57400, France

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Savonnières, 37510, France

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Scorbé-Clairvaux, 86140, France

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Segré, 49500, France

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Seysses, 31600, France

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St-Malo, 35400, France

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Thionville, 57100, France

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Thouars, 79100, France

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GSK Investigational Site

Tiercé, 49125, France

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Toulouse, 31200, France

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Tours, 37000, France

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Tours, 37100, France

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Vannes, 56000, France

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Verzy, 51380, France

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Vihiers, 49310, France

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Villey-Saint-Étienne, 54200, France

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Vitré, 35500, France

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Vue, 44640, France

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Witry-lès-Reims, 51420, France

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Yerres, 91330, France

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Bruchsal, Baden-Wurttemberg, 76646, Germany

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Ettlingen, Baden-Wurttemberg, 76275, Germany

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Mannheim, Baden-Wurttemberg, 68161, Germany

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Messkirch, Baden-Wurttemberg, 88605, Germany

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Sinsheim, Baden-Wurttemberg, 74889, Germany

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Weinheim, Baden-Wurttemberg, 69469, Germany

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Bad Woerrishofen, Bavaria, 86825, Germany

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Munich, Bavaria, 80335, Germany

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Potsdam, Brandenburg, 14469, Germany

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Potsdam, Brandenburg, 14478, Germany

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Bensheim, Hesse, 64625, Germany

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Flörsheim, Hesse, 65439, Germany

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Kelkheim, Hesse, 65779, Germany

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Neu-Isenburg, Hesse, 63263, Germany

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Offenbach, Hesse, 63071, Germany

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Hanover, Lower Saxony, 30159, Germany

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Wardenburg, Lower Saxony, 26203, Germany

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Bonn, North Rhine-Westphalia, 53119, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Düren, North Rhine-Westphalia, 52349, Germany

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Essen, North Rhine-Westphalia, 45359, Germany

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Goch, North Rhine-Westphalia, 47574, Germany

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Hagen, North Rhine-Westphalia, 58095, Germany

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Harsewinkel, North Rhine-Westphalia, 33428, Germany

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Rheine, North Rhine-Westphalia, 48431, Germany

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Solingen, North Rhine-Westphalia, 42651, Germany

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Witten, North Rhine-Westphalia, 58452, Germany

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Ingelheim, Rhineland-Palatinate, 55218, Germany

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Mainz, Rhineland-Palatinate, 55116, Germany

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Mainz, Rhineland-Palatinate, 55128, Germany

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Nußbach, Rhineland-Palatinate, 67759, Germany

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Dresden, Saxony, 01069, Germany

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Riesa, Saxony, 01587, Germany

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Köthen, Saxony-Anhalt, 06366, Germany

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Zerbst, Saxony-Anhalt, 39261, Germany

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Bad Segeberg, Schleswig-Holstein, 23795, Germany

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Lübeck, Schleswig-Holstein, 23554, Germany

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Lübeck, Schleswig-Holstein, 23562, Germany

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Reinfeld, Schleswig-Holstein, 23858, Germany

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GSK Investigational Site

Berlin, 10555, Germany

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Berlin, 14052, Germany

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Hamburg, 22143, Germany

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GSK Investigational Site

's-Hertogenbosch, 5235 KG, Netherlands

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GSK Investigational Site

Andijk, 1619XK, Netherlands

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GSK Investigational Site

Beek en Donk, 5741 CG, Netherlands

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GSK Investigational Site

Deurne, 5751 XJ, Netherlands

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Eersel, 5521 WD, Netherlands

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GSK Investigational Site

Enschede, 7544 BA, Netherlands

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GSK Investigational Site

Ermelo, 3851 EX, Netherlands

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Hoogwoud, 1718 BG, Netherlands

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GSK Investigational Site

Kloosterhaar, 7694 AC, Netherlands

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Lieshout, 5737 CB, Netherlands

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GSK Investigational Site

Musselkanaal, 9581 AJ, Netherlands

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Nijverdal, 7442 LS, Netherlands

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Soerendonk, 6027 PL, Netherlands

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GSK Investigational Site

Spijkenisse, 3207 NB, Netherlands

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The Hague, 2517 EW, Netherlands

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GSK Investigational Site

The Hague, 2582 LJ, Netherlands

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GSK Investigational Site

Voerendaal, 6367 ED, Netherlands

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GSK Investigational Site

Wildervank, 9648 BE, Netherlands

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Zaandam, 1504 JA, Netherlands

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GSK Investigational Site

Zwijndrecht, 3334 CL, Netherlands

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GSK Investigational Site

Bydgoszcz, 85-046, Poland

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Bydgoszcz, 85-796, Poland

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Bydgoszcz, 85-863, Poland

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Częstochowa, 42-200, Poland

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Domaradz, 36-230, Poland

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Elblag, 82-300, Poland

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Jasło, 38-200, Poland

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Katowice, 40-055, Poland

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Katowice, 40-645, Poland

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Katowice, 40-750, Poland

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Katowice, 40-954, Poland

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Krakow, 30-015, Poland

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Krakow, 30-053, Poland

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Krakow, 30-347, Poland

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Krakow, 31-637, Poland

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Libiąż, 32-590, Poland

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Lodz, 90-265, Poland

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Lublin, 20-854, Poland

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Mielec, 39-300, Poland

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Oświęcim, 32-600, Poland

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Puławy, 24-100, Poland

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Radom, Poland

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Radziszów, 32-052, Poland

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Rzeszów, 35-055, Poland

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Rzeszów, 35-068, Poland

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Tarnów, 33-100, Poland

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Torun, 87-100, Poland

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Warsaw, 01-231, Poland

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Warsaw, 01-868, Poland

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Wroclaw, 50-127, Poland

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Wroclaw, 50-349, Poland

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Zabrze, 41-800, Poland

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Zgierz, 95-100, Poland

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GSK Investigational Site

Zgłobień, 36-046, Poland

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GSK Investigational Site

A Coruña, 15008, Spain

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Algeciras, 11205, Spain

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Alicante, 03005, Spain

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GSK Investigational Site

Barakaldo, 48903, Spain

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GSK Investigational Site

Barcelona, 08018, Spain

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GSK Investigational Site

Barcelona, 08023, Spain

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GSK Investigational Site

Barcelona, 08028, Spain

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GSK Investigational Site

Barcelona, 08033, Spain

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GSK Investigational Site

Barcelona, 08034, Spain

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GSK Investigational Site

Barcelona, 08041, Spain

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GSK Investigational Site

Barcelona, 8025, Spain

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GSK Investigational Site

Benidor / Alicante, 03503, Spain

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GSK Investigational Site

Canet de Mar - Barcelona, 08360, Spain

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GSK Investigational Site

Colloto - Oviedo, 33010, Spain

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GSK Investigational Site

Cornellá de Llobregat-Barcelona, 08940, Spain

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GSK Investigational Site

Culleredo - La Coruña, 15670, Spain

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GSK Investigational Site

El Puerto de Santa María-Cádiz, 11500, Spain

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GSK Investigational Site

Fuenlabrada / Madrid, 28943, Spain

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GSK Investigational Site

Gijón, 33211, Spain

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GSK Investigational Site

Gijón, 33212, Spain

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GSK Investigational Site

Gijón. Asturias., 33213, Spain

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GSK Investigational Site

Güeñes - Vizcaya, 48830, Spain

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GSK Investigational Site

Hostalric - Gerona, 17450, Spain

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GSK Investigational Site

La Roca Del Valles (Barcelona), 08430, Spain

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GSK Investigational Site

Les Franqueses Del Vallés - Barcelona, 08530, Spain

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GSK Investigational Site

Madrid, 28700, Spain

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GSK Investigational Site

Mataró, 08303, Spain

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GSK Investigational Site

Mataró. Barcelona., 08302, Spain

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GSK Investigational Site

Málaga, 29014, Spain

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Murcia, 30010, Spain

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GSK Investigational Site

Oviedo, 33009, Spain

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GSK Investigational Site

Oviedo, Spain

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GSK Investigational Site

Peralada( Girona), 17491, Spain

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GSK Investigational Site

Petrer/Alicante, 03610, Spain

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GSK Investigational Site

Portugalete - Vizcaya, 48920, Spain

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San Juan, Spain

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GSK Investigational Site

Santa Coloma de Gramanet - Barcelona, 08924, Spain

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Valencia, 46021, Spain

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GSK Investigational Site

Valencia, Spain

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 25, 2012
• Study Start: November 17, 2011
• Primary Completion: May 1, 2015
• Study Completion: June 12, 2015
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

BE (1); DE (42); ES (39); NL (20); FR (97); PL (34)