Clinical trial NCT01516528: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Official title: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
exacerbation
comorbidities
lung function
burden
chronic bronchitis
emphysema
prevalence
cardiovascular disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 3500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care outpatients who have a an established clinical history of COPD for a minimum of 12 months.

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.

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 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.

Primary outcomes:
measure: Frequency of COPD Exacerbation
timeFrame: From 15 months pre-baseline to 24 months post-baseline.
measure: Presence and severity of cardiovascular disease.
timeFrame: From 3 months pre-baseline to 24 months post-baseline.
Secondary outcomes:
measure: Presence and severity of other comorbidities
timeFrame: Up to 24 months post baseline.
measure: Spirometry
timeFrame: Up to 24 months post baseline.
measure: Health status
timeFrame: Up to 24 months post baseline.
measure: Dyspnoea
timeFrame: Up to 24 months post baseline.
measure: Number of Deaths
timeFrame: up to 24 months post baseline.
measure: Healthcare Utilisation
timeFrame: Up to 24 months post baseline.
measure: Blood Chemistry
timeFrame: Up to 24 months post baseline.
measure: Electrocardiogram
timeFrame: Up to 24 months post baseline.
measure: Bone fractures
timeFrame: Within 12 months prior to baseline and up to 24 months post baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Angers cedex 9
country: France
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Aumetz
country: France
facility: GSK Investigational Site
city: Beziers
country: France
facility: GSK Investigational Site
city: Blois
country: France
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Bouliac
country: France
facility: GSK Investigational Site
city: Bourg Des Comptes
country: France
facility: GSK Investigational Site
city: Briollay
country: France
facility: GSK Investigational Site
city: Carbon Blanc
country: France
facility: GSK Investigational Site
city: Carbonne
country: France
facility: GSK Investigational Site
city: Chatellerault
country: France
facility: GSK Investigational Site
city: Chatou
country: France
facility: GSK Investigational Site
city: Cholet
country: France
facility: GSK Investigational Site
city: Chollet
country: France
facility: GSK Investigational Site
city: Couzeix
country: France
facility: GSK Investigational Site
city: Cugnaux
country: France
facility: GSK Investigational Site
city: Dinard
country: France
facility: GSK Investigational Site
city: Donges
country: France
facility: GSK Investigational Site
city: Escoublac
country: France
facility: GSK Investigational Site
city: Franconville
country: France
facility: GSK Investigational Site
city: Gemozac
country: France
facility: GSK Investigational Site
city: Grandchamps
country: France
facility: GSK Investigational Site
city: Haute Goulaine
country: France
facility: GSK Investigational Site
city: Houilles
country: France
facility: GSK Investigational Site
city: La Bouexiere
country: France
facility: GSK Investigational Site
city: La Fresnais
country: France
facility: GSK Investigational Site
city: La Fôret sur Sèvres
country: France
facility: GSK Investigational Site
city: La Jubaudière
country: France
facility: GSK Investigational Site
city: La Montagne
country: France
facility: GSK Investigational Site
city: La Riche
country: France
facility: GSK Investigational Site
city: La Rochelle
country: France
facility: GSK Investigational Site
city: La Teste de Buch
country: France
facility: GSK Investigational Site
city: La Varenne
country: France
facility: GSK Investigational Site
city: Le Bono
country: France
facility: GSK Investigational Site
city: Le Fousseret
country: France
facility: GSK Investigational Site
city: Le Mesnil en Vallée
country: France
facility: GSK Investigational Site
city: Les Ponts de Cé
country: France
facility: GSK Investigational Site
city: Liffre
country: France
facility: GSK Investigational Site
city: Limoges
country: France
facility: GSK Investigational Site
city: Limoges
country: France
facility: GSK Investigational Site
city: Louvigne de Bais
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Martin Eglise
country: France
facility: GSK Investigational Site
city: Montreuil Juigne
country: France
facility: GSK Investigational Site
city: Montrevault
country: France
facility: GSK Investigational Site
city: Mouliherne
country: France
facility: GSK Investigational Site
city: Moulins les Metz
country: France
facility: GSK Investigational Site
city: Muret
country: France
facility: GSK Investigational Site
city: Murs-Erigne
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Nexon
country: France
facility: GSK Investigational Site
city: Nieul sur Mer
country: France
facility: GSK Investigational Site
city: Parcay les Pins
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Perigny
country: France
facility: GSK Investigational Site
city: Pont à Mousson
country: France
facility: GSK Investigational Site
city: Rennes
country: France
facility: GSK Investigational Site
city: Rosiers d'Egletons
country: France
facility: GSK Investigational Site
city: Royan
country: France
facility: GSK Investigational Site
city: Saint Aubin des Chateaux
country: France
facility: GSK Investigational Site
city: Saint Cyr sur Loire
country: France
facility: GSK Investigational Site
city: Saint Etienne de Montluc
country: France
facility: GSK Investigational Site
city: Saint Georges de Montaigu
country: France
facility: GSK Investigational Site
city: Saint Herblain
country: France
facility: GSK Investigational Site
city: Saint Jouan des Guerets
country: France
facility: GSK Investigational Site
city: Saint Malo
country: France
facility: GSK Investigational Site
city: Saint Max
country: France
facility: GSK Investigational Site
city: Saint Médard en Jalles
country: France
facility: GSK Investigational Site
city: Saint Orens de Gameville
country: France
facility: GSK Investigational Site
city: Saint Pierre en Val
country: France
facility: GSK Investigational Site
city: Saint-Etienne
country: France
facility: GSK Investigational Site
city: Saint-Loubès
country: France
facility: GSK Investigational Site
city: Sarrebourg
country: France
facility: GSK Investigational Site
city: Savonnières
country: France
facility: GSK Investigational Site
city: Scorbe Clairvaux
country: France
facility: GSK Investigational Site
city: Segré
country: France
facility: GSK Investigational Site
city: Seysses
country: France
facility: GSK Investigational Site
city: Thionville
country: France
facility: GSK Investigational Site
city: Thouars
country: France
facility: GSK Investigational Site
city: Tierce
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Vannes
country: France
facility: GSK Investigational Site
city: Verzy
country: France
facility: GSK Investigational Site
city: Vihiers
country: France
facility: GSK Investigational Site
city: Villey Saint Etienne
country: France
facility: GSK Investigational Site
city: Vitré
country: France
facility: GSK Investigational Site
city: Vue
country: France
facility: GSK Investigational Site
city: Witry les Reims
country: France
facility: GSK Investigational Site
city: Yerres
country: France
facility: GSK Investigational Site
city: Bruchsal
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Messkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bad Woerrishofen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Bensheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Floersheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kelkheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Neu-Isenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wardenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dueren
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hagen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Harsewinkel
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Rheine
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Ingelheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Nussbach
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Koethen
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Zerbst
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Riesa
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Reinfeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Andijk
country: Netherlands
facility: GSK Investigational Site
city: Beek En Donk
country: Netherlands
facility: GSK Investigational Site
city: Den Bosch
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Deurne
country: Netherlands
facility: GSK Investigational Site
city: Eersel
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Ermelo
country: Netherlands
facility: GSK Investigational Site
city: Hoogwoud
country: Netherlands
facility: GSK Investigational Site
city: Kloosterhaar
country: Netherlands
facility: GSK Investigational Site
city: Lieshout
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
country: Netherlands
facility: GSK Investigational Site
city: Soerendonk
country: Netherlands
facility: GSK Investigational Site
city: Spijkenisse
country: Netherlands
facility: GSK Investigational Site
city: Voerendaal
country: Netherlands
facility: GSK Investigational Site
city: Wildervank
country: Netherlands
facility: GSK Investigational Site
city: Zaandam
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Domaradz
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Jaslo
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Libiaz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Mielec
country: Poland
facility: GSK Investigational Site
city: Oswiecim
country: Poland
facility: GSK Investigational Site
city: Pulawy
country: Poland
facility: GSK Investigational Site
city: Radom
country: Poland
facility: GSK Investigational Site
city: Radziszow
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Zgierz
country: Poland
facility: GSK Investigational Site
city: Zglobien
country: Poland
facility: GSK Investigational Site
city: Algeciras
country: Spain
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Baracaldo
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Benidor / Alicante
country: Spain
facility: GSK Investigational Site
city: Canet de Mar - Barcelona
country: Spain
facility: GSK Investigational Site
city: Colloto - Oviedo
country: Spain
facility: GSK Investigational Site
city: Cornellá de Llobregat-Barcelona
country: Spain
facility: GSK Investigational Site
city: Culleredo - La Coruña
country: Spain
facility: GSK Investigational Site
city: El Puerto de Santa María-Cádiz
country: Spain
facility: GSK Investigational Site
city: Fuenlabrada / Madrid
country: Spain
facility: GSK Investigational Site
city: Gijón. Asturias.
country: Spain
facility: GSK Investigational Site
city: Gijón
country: Spain
facility: GSK Investigational Site
city: Gijón
country: Spain
facility: GSK Investigational Site
city: Güeñes - Vizcaya
country: Spain
facility: GSK Investigational Site
city: Hostalric - Gerona
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: La Roca del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Les Franqueses del Vallés - Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Mataró. Barcelona.
country: Spain
facility: GSK Investigational Site
city: Mataró
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: peralada( Girona)
country: Spain
facility: GSK Investigational Site
city: Petrer/Alicante
country: Spain
facility: GSK Investigational Site
city: Portugalete - Vizcaya
country: Spain
facility: GSK Investigational Site
city: San Juan
country: Spain
facility: GSK Investigational Site
city: Santa Coloma de Gramanet - Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: