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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516528
• Other study ID #: 115058
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: September 18, 2017
• Start date: November 17, 2011
• Est. completion date: June 12, 2015

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: June 12, 2015
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Spirometry
Assessment of lung function by spirometry

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

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