MedDataX Logo

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

NCT ID: NCT01516528

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-17

Study Completion Date

2015-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All

All subjects enrolled in the study

Spirometry

Intervention Type PROCEDURE

Assessment of lung function by spirometry

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spirometry

Assessment of lung function by spirometry

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Leuven, , Belgium

Site Status

GSK Investigational Site

Angers, , France

Site Status

GSK Investigational Site

Angers, , France

Site Status

GSK Investigational Site

Angers, , France

Site Status

GSK Investigational Site

Aumetz, , France

Site Status

GSK Investigational Site

Béziers, , France

Site Status

GSK Investigational Site

Blois, , France

Site Status

GSK Investigational Site

Bono, , France

Site Status

GSK Investigational Site

Bordeaux, , France

Site Status

GSK Investigational Site

Bouliac, , France

Site Status

GSK Investigational Site

Bourg-des-Comptes, , France

Site Status

GSK Investigational Site

Briollay, , France

Site Status

GSK Investigational Site

Carbon-Blanc, , France

Site Status

GSK Investigational Site

Carbonne, , France

Site Status

GSK Investigational Site

Chatou, , France

Site Status

GSK Investigational Site

Châtellerault, , France

Site Status

GSK Investigational Site

Cholet, , France

Site Status

GSK Investigational Site

Chollet, , France

Site Status

GSK Investigational Site

Couzeix, , France

Site Status

GSK Investigational Site

Cugnaux, , France

Site Status

GSK Investigational Site

Dinard, , France

Site Status

GSK Investigational Site

Donges, , France

Site Status

GSK Investigational Site

Franconville, , France

Site Status

GSK Investigational Site

Gémozac, , France

Site Status

GSK Investigational Site

Grandchamps, , France

Site Status

GSK Investigational Site

Haute-Goulaine, , France

Site Status

GSK Investigational Site

Houilles, , France

Site Status

GSK Investigational Site

La Baule-Escoublac, , France

Site Status

GSK Investigational Site

La Bouëxière, , France

Site Status

GSK Investigational Site

La Fôret Sur Sèvres, , France

Site Status

GSK Investigational Site

La Fresnais, , France

Site Status

GSK Investigational Site

La Jubaudière, , France

Site Status

GSK Investigational Site

La Montagne, , France

Site Status

GSK Investigational Site

La Riche, , France

Site Status

GSK Investigational Site

La Rochelle, , France

Site Status

GSK Investigational Site

La Teste-de-Buch, , France

Site Status

GSK Investigational Site

La Varenne, , France

Site Status

GSK Investigational Site

Le Fousseret, , France

Site Status

GSK Investigational Site

Le Mesnil-en-Vallée, , France

Site Status

GSK Investigational Site

Les Ponts-de-Cé, , France

Site Status

GSK Investigational Site

Liffré, , France

Site Status

GSK Investigational Site

Limoges, , France

Site Status

GSK Investigational Site

Limoges, , France

Site Status

GSK Investigational Site

Louvigné-de-Bais, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Martin-Église, , France

Site Status

GSK Investigational Site

Montreuil-Juigné, , France

Site Status

GSK Investigational Site

Montrevault, , France

Site Status

GSK Investigational Site

Mouliherne, , France

Site Status

GSK Investigational Site

Moulins-lès-Metz, , France

Site Status

GSK Investigational Site

Muret, , France

Site Status

GSK Investigational Site

Mûrs-Erigné, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nexon, , France

Site Status

GSK Investigational Site

Nieul-sur-Mer, , France

Site Status

GSK Investigational Site

Parçay-les-Pins, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Périgny, , France

Site Status

GSK Investigational Site

Pont-à-Mousson, , France

Site Status

GSK Investigational Site

Rennes, , France

Site Status

GSK Investigational Site

Rosiers-d'Égletons, , France

Site Status

GSK Investigational Site

Royan, , France

Site Status

GSK Investigational Site

Saint-Aubin-des-Châteaux, , France

Site Status

GSK Investigational Site

Saint-Cyr-sur-Loire, , France

Site Status

GSK Investigational Site

Saint-Etienne, , France

Site Status

GSK Investigational Site

Saint-Étienne-de-Montluc, , France

Site Status

GSK Investigational Site

Saint-Georges-de-Montaigu, , France

Site Status

GSK Investigational Site

Saint-Herblain, , France

Site Status

GSK Investigational Site

Saint-Jouan-des-Guérets, , France

Site Status

GSK Investigational Site

Saint-Loubès, , France

Site Status

GSK Investigational Site

Saint-Max, , France

Site Status

GSK Investigational Site

Saint-Médard-en-Jalles, , France

Site Status

GSK Investigational Site

Saint-Orens-de-Gameville, , France

Site Status

GSK Investigational Site

Saint-Pierre-en-Val, , France

Site Status

GSK Investigational Site

Sarrebourg, , France

Site Status

GSK Investigational Site

Savonnières, , France

Site Status

GSK Investigational Site

Scorbé-Clairvaux, , France

Site Status

GSK Investigational Site

Segré, , France

Site Status

GSK Investigational Site

Seysses, , France

Site Status

GSK Investigational Site

St-Malo, , France

Site Status

GSK Investigational Site

Thionville, , France

Site Status

GSK Investigational Site

Thouars, , France

Site Status

GSK Investigational Site

Tiercé, , France

Site Status

GSK Investigational Site

Toulouse, , France

Site Status

GSK Investigational Site

Tours, , France

Site Status

GSK Investigational Site

Tours, , France

Site Status

GSK Investigational Site

Vannes, , France

Site Status

GSK Investigational Site

Verzy, , France

Site Status

GSK Investigational Site

Vihiers, , France

Site Status

GSK Investigational Site

Villey-Saint-Étienne, , France

Site Status

GSK Investigational Site

Vitré, , France

Site Status

GSK Investigational Site

Vue, , France

Site Status

GSK Investigational Site

Witry-lès-Reims, , France

Site Status

GSK Investigational Site

Yerres, , France

Site Status

GSK Investigational Site

Bruchsal, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ettlingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Messkirch, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Sinsheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bad Woerrishofen, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Potsdam, Brandenburg, Germany

Site Status

GSK Investigational Site

Potsdam, Brandenburg, Germany

Site Status

GSK Investigational Site

Bensheim, Hesse, Germany

Site Status

GSK Investigational Site

Flörsheim, Hesse, Germany

Site Status

GSK Investigational Site

Kelkheim, Hesse, Germany

Site Status

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

Site Status

GSK Investigational Site

Offenbach, Hesse, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Wardenburg, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Düren, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hagen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Harsewinkel, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Rheine, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Ingelheim, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Nußbach, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Riesa, Saxony, Germany

Site Status

GSK Investigational Site

Köthen, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Zerbst, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Reinfeld, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

GSK Investigational Site

Andijk, , Netherlands

Site Status

GSK Investigational Site

Beek en Donk, , Netherlands

Site Status

GSK Investigational Site

Deurne, , Netherlands

Site Status

GSK Investigational Site

Eersel, , Netherlands

Site Status

GSK Investigational Site

Enschede, , Netherlands

Site Status

GSK Investigational Site

Ermelo, , Netherlands

Site Status

GSK Investigational Site

Hoogwoud, , Netherlands

Site Status

GSK Investigational Site

Kloosterhaar, , Netherlands

Site Status

GSK Investigational Site

Lieshout, , Netherlands

Site Status

GSK Investigational Site

Musselkanaal, , Netherlands

Site Status

GSK Investigational Site

Nijverdal, , Netherlands

Site Status

GSK Investigational Site

Soerendonk, , Netherlands

Site Status

GSK Investigational Site

Spijkenisse, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Voerendaal, , Netherlands

Site Status

GSK Investigational Site

Wildervank, , Netherlands

Site Status

GSK Investigational Site

Zaandam, , Netherlands

Site Status

GSK Investigational Site

Zwijndrecht, , Netherlands

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Częstochowa, , Poland

Site Status

GSK Investigational Site

Domaradz, , Poland

Site Status

GSK Investigational Site

Elblag, , Poland

Site Status

GSK Investigational Site

Jasło, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Libiąż, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Lublin, , Poland

Site Status

GSK Investigational Site

Mielec, , Poland

Site Status

GSK Investigational Site

Oświęcim, , Poland

Site Status

GSK Investigational Site

Puławy, , Poland

Site Status

GSK Investigational Site

Radom, , Poland

Site Status

GSK Investigational Site

Radziszów, , Poland

Site Status

GSK Investigational Site

Rzeszów, , Poland

Site Status

GSK Investigational Site

Rzeszów, , Poland

Site Status

GSK Investigational Site

Tarnów, , Poland

Site Status

GSK Investigational Site

Torun, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Zabrze, , Poland

Site Status

GSK Investigational Site

Zgierz, , Poland

Site Status

GSK Investigational Site

Zgłobień, , Poland

Site Status

GSK Investigational Site

A Coruña, , Spain

Site Status

GSK Investigational Site

Algeciras, , Spain

Site Status

GSK Investigational Site

Alicante, , Spain

Site Status

GSK Investigational Site

Barakaldo, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Benidor / Alicante, , Spain

Site Status

GSK Investigational Site

Canet de Mar - Barcelona, , Spain

Site Status

GSK Investigational Site

Colloto - Oviedo, , Spain

Site Status

GSK Investigational Site

Cornellá de Llobregat-Barcelona, , Spain

Site Status

GSK Investigational Site

Culleredo - La Coruña, , Spain

Site Status

GSK Investigational Site

El Puerto de Santa María-Cádiz, , Spain

Site Status

GSK Investigational Site

Fuenlabrada / Madrid, , Spain

Site Status

GSK Investigational Site

Gijón, , Spain

Site Status

GSK Investigational Site

Gijón, , Spain

Site Status

GSK Investigational Site

Gijón. Asturias., , Spain

Site Status

GSK Investigational Site

Güeñes - Vizcaya, , Spain

Site Status

GSK Investigational Site

Hostalric - Gerona, , Spain

Site Status

GSK Investigational Site

La Roca Del Valles (Barcelona), , Spain

Site Status

GSK Investigational Site

Les Franqueses Del Vallés - Barcelona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Mataró, , Spain

Site Status

GSK Investigational Site

Mataró. Barcelona., , Spain

Site Status

GSK Investigational Site

Málaga, , Spain

Site Status

GSK Investigational Site

Murcia, , Spain

Site Status

GSK Investigational Site

Oviedo, , Spain

Site Status

GSK Investigational Site

Oviedo, , Spain

Site Status

GSK Investigational Site

Peralada( Girona), , Spain

Site Status

GSK Investigational Site

Petrer/Alicante, , Spain

Site Status

GSK Investigational Site

Portugalete - Vizcaya, , Spain

Site Status

GSK Investigational Site

San Juan, , Spain

Site Status

GSK Investigational Site

Santa Coloma de Gramanet - Barcelona, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium France Germany Netherlands Poland Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

115058

Identifier Type: -

Identifier Source: org_study_id