Pulmonary Disease, Chronic ObstructiveACCESSNCT01516528

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 233 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Spirometry
Type of treatment: Surgery or procedure
How many people: 3,500 participants
Where: 233 sitesin 6 countries
Study dates: 17 Nov 2011to 12 Jun 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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 Patients diagnosed with cancer during the study will be withdrawn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.

Trial locations and contacts

233 sites in 6 countries.

Country

City, postcode or hospital

233 sites in 6 countries

France97 sites

GSK Investigational Site
Angers, 49000
GSK Investigational Site
Angers, 49100
GSK Investigational Site
Angers, 49933
GSK Investigational Site
Aumetz, 57710
GSK Investigational Site
Béziers, 34500
GSK Investigational Site
Blois, 41000
GSK Investigational Site
Bono, 56400
GSK Investigational Site
Bordeaux, 33200
GSK Investigational Site
Bouliac, 33270
GSK Investigational Site
Bourg-des-Comptes, 35890
GSK Investigational Site
Briollay, 49125
GSK Investigational Site
Carbon-Blanc, 33650
GSK Investigational Site
Carbonne, 31390
GSK Investigational Site
Châtellerault, 86100
GSK Investigational Site
Chatou, 78400
GSK Investigational Site
Cholet, 49300
GSK Investigational Site
Chollet, 49300
GSK Investigational Site
Couzeix, 87270
GSK Investigational Site
Cugnaux, 31270
GSK Investigational Site
Dinard, 35800
GSK Investigational Site
Donges, 44480
GSK Investigational Site
Franconville, 95130
GSK Investigational Site
Gémozac, 17260
GSK Investigational Site
Grandchamps, 56390
GSK Investigational Site
Haute-Goulaine, 44115
GSK Investigational Site
Houilles, 78800
GSK Investigational Site
La Baule-Escoublac, 44500
GSK Investigational Site
La Bouëxière, 35340
GSK Investigational Site
La Fôret Sur Sèvres, 79380
GSK Investigational Site
La Fresnais, 35111
GSK Investigational Site
La Jubaudière, 49510
GSK Investigational Site
La Montagne, 44620
GSK Investigational Site
La Riche, 37250
GSK Investigational Site
La Rochelle, 17000
GSK Investigational Site
La Teste-de-Buch, 33260
GSK Investigational Site
La Varenne, 49270
GSK Investigational Site
Le Fousseret, 31430
GSK Investigational Site
Le Mesnil-en-Vallée, 49410
GSK Investigational Site
Les Ponts-de-Cé, 49130
GSK Investigational Site
Liffré, 35340
GSK Investigational Site
Limoges, 87000
GSK Investigational Site
Limoges, 87100
GSK Investigational Site
Louvigné-de-Bais, 35680
GSK Investigational Site
Marseille, 13009
GSK Investigational Site
Martin-Église, 76370
GSK Investigational Site
Montreuil-Juigné, 49460
GSK Investigational Site
Montrevault, 49110
GSK Investigational Site
Mouliherne, 49390
GSK Investigational Site
Moulins-lès-Metz, 57160
GSK Investigational Site
Muret, 31600
GSK Investigational Site
Mûrs-Erigné, 49610
GSK Investigational Site
Nantes, 44000
GSK Investigational Site
Nantes, 44300
GSK Investigational Site
Nexon, 87800
GSK Investigational Site
Nieul-sur-Mer, 17137
GSK Investigational Site
Parçay-les-Pins, 49390
GSK Investigational Site
Paris, 75011
GSK Investigational Site
Paris, 75013
GSK Investigational Site
Paris, 75019
GSK Investigational Site
Paris, 75020
GSK Investigational Site
Périgny, 17180
GSK Investigational Site
Pont-à-Mousson, 54700
GSK Investigational Site
Rennes, 35000
GSK Investigational Site
Rosiers-d'Égletons, 19300
GSK Investigational Site
Royan, 17200
GSK Investigational Site
Saint-Aubin-des-Châteaux, 44110
GSK Investigational Site
Saint-Cyr-sur-Loire, 37540
GSK Investigational Site
Saint-Etienne, 42100
GSK Investigational Site
Saint-Étienne-de-Montluc, 44360
GSK Investigational Site
Saint-Georges-de-Montaigu, 85600
GSK Investigational Site
Saint-Herblain, 44800
GSK Investigational Site
Saint-Jouan-des-Guérets, 35430
GSK Investigational Site
Saint-Loubès, 33450
GSK Investigational Site
Saint-Max, 54130
GSK Investigational Site
Saint-Médard-en-Jalles, 33160
GSK Investigational Site
Saint-Orens-de-Gameville, 31650
GSK Investigational Site
Saint-Pierre-en-Val, 76260
GSK Investigational Site
Sarrebourg, 57400
GSK Investigational Site
Savonnières, 37510
GSK Investigational Site
Scorbé-Clairvaux, 86140
GSK Investigational Site
Segré, 49500
GSK Investigational Site
Seysses, 31600
GSK Investigational Site
St-Malo, 35400
GSK Investigational Site
Thionville, 57100
GSK Investigational Site
Thouars, 79100
GSK Investigational Site
Tiercé, 49125
GSK Investigational Site
Toulouse, 31200
GSK Investigational Site
Tours, 37000
GSK Investigational Site
Tours, 37100
GSK Investigational Site
Vannes, 56000
GSK Investigational Site
Verzy, 51380
GSK Investigational Site
Vihiers, 49310
GSK Investigational Site
Villey-Saint-Étienne, 54200
GSK Investigational Site
Vitré, 35500
GSK Investigational Site
Vue, 44640
GSK Investigational Site
Witry-lès-Reims, 51420
GSK Investigational Site
Yerres, 91330

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Germany42 sites

GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Bad Woerrishofen, Bavaria, 86825
GSK Investigational Site
Bensheim, Hesse, 64625
GSK Investigational Site
Berlin, 10555
GSK Investigational Site
Berlin, 14052
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dresden, Saxony, 01069
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Ettlingen, Baden-Wurttemberg, 76275
GSK Investigational Site
Flörsheim, Hesse, 65439
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58095
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Harsewinkel, North Rhine-Westphalia, 33428
GSK Investigational Site
Ingelheim, Rhineland-Palatinate, 55218
GSK Investigational Site
Kelkheim, Hesse, 65779
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23562
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55128
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Messkirch, Baden-Wurttemberg, 88605
GSK Investigational Site
Munich, Bavaria, 80335
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
GSK Investigational Site
Nußbach, Rhineland-Palatinate, 67759
GSK Investigational Site
Offenbach, Hesse, 63071
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Potsdam, Brandenburg, 14469
GSK Investigational Site
Potsdam, Brandenburg, 14478
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858
GSK Investigational Site
Rheine, North Rhine-Westphalia, 48431
GSK Investigational Site
Riesa, Saxony, 01587
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42651
GSK Investigational Site
Wardenburg, Lower Saxony, 26203
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452
GSK Investigational Site
Zerbst, Saxony-Anhalt, 39261

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Spain39 sites

GSK Investigational Site
A Coruña, 15008
GSK Investigational Site
Algeciras, 11205
GSK Investigational Site
Alicante, 03005
GSK Investigational Site
Barakaldo, 48903
GSK Investigational Site
Barcelona, 08018
GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08028
GSK Investigational Site
Barcelona, 08033
GSK Investigational Site
Barcelona, 08034
GSK Investigational Site
Barcelona, 08041
GSK Investigational Site
Barcelona, 8025
GSK Investigational Site
Benidor / Alicante, 03503
GSK Investigational Site
Canet de Mar - Barcelona, 08360
GSK Investigational Site
Colloto - Oviedo, 33010
GSK Investigational Site
Cornellá de Llobregat-Barcelona, 08940
GSK Investigational Site
Culleredo - La Coruña, 15670
GSK Investigational Site
El Puerto de Santa María-Cádiz, 11500
GSK Investigational Site
Fuenlabrada / Madrid, 28943
GSK Investigational Site
Gijón, 33211
GSK Investigational Site
Gijón, 33212
GSK Investigational Site
Gijón. Asturias., 33213
GSK Investigational Site
Güeñes - Vizcaya, 48830
GSK Investigational Site
Hostalric - Gerona, 17450
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430
GSK Investigational Site
Les Franqueses Del Vallés - Barcelona, 08530
GSK Investigational Site
Madrid, 28700
GSK Investigational Site
Málaga, 29014
GSK Investigational Site
Mataró, 08303
GSK Investigational Site
Mataró. Barcelona., 08302
GSK Investigational Site
Murcia, 30010
GSK Investigational Site
Oviedo, 33009
GSK Investigational Site
Oviedo
GSK Investigational Site
Peralada( Girona), 17491
GSK Investigational Site
Petrer/Alicante, 03610
GSK Investigational Site
Portugalete - Vizcaya, 48920
GSK Investigational Site
San Juan
GSK Investigational Site
Santa Coloma de Gramanet - Barcelona, 08924
GSK Investigational Site
Valencia, 46021
GSK Investigational Site
Valencia

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Poland34 sites

GSK Investigational Site
Bydgoszcz, 85-046
GSK Investigational Site
Bydgoszcz, 85-796
GSK Investigational Site
Bydgoszcz, 85-863
GSK Investigational Site
Częstochowa, 42-200
GSK Investigational Site
Domaradz, 36-230
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Jasło, 38-200
GSK Investigational Site
Katowice, 40-055
GSK Investigational Site
Katowice, 40-645
GSK Investigational Site
Katowice, 40-750
GSK Investigational Site
Katowice, 40-954
GSK Investigational Site
Krakow, 30-015
GSK Investigational Site
Krakow, 30-053
GSK Investigational Site
Krakow, 30-347
GSK Investigational Site
Krakow, 31-637
GSK Investigational Site
Libiąż, 32-590
GSK Investigational Site
Lodz, 90-265
GSK Investigational Site
Lublin, 20-854
GSK Investigational Site
Mielec, 39-300
GSK Investigational Site
Oświęcim, 32-600
GSK Investigational Site
Puławy, 24-100
GSK Investigational Site
Radom
GSK Investigational Site
Radziszów, 32-052
GSK Investigational Site
Rzeszów, 35-055
GSK Investigational Site
Rzeszów, 35-068
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Torun, 87-100
GSK Investigational Site
Warsaw, 01-231
GSK Investigational Site
Warsaw, 01-868
GSK Investigational Site
Wroclaw, 50-127
GSK Investigational Site
Wroclaw, 50-349
GSK Investigational Site
Zabrze, 41-800
GSK Investigational Site
Zgierz, 95-100
GSK Investigational Site
Zgłobień, 36-046

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Netherlands20 sites

GSK Investigational Site
's-Hertogenbosch, 5235 KG
GSK Investigational Site
Andijk, 1619XK
GSK Investigational Site
Beek en Donk, 5741 CG
GSK Investigational Site
Deurne, 5751 XJ
GSK Investigational Site
Eersel, 5521 WD
GSK Investigational Site
Enschede, 7544 BA
GSK Investigational Site
Ermelo, 3851 EX
GSK Investigational Site
Hoogwoud, 1718 BG
GSK Investigational Site
Kloosterhaar, 7694 AC
GSK Investigational Site
Lieshout, 5737 CB
GSK Investigational Site
Musselkanaal, 9581 AJ
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Soerendonk, 6027 PL
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
The Hague, 2517 EW
GSK Investigational Site
The Hague, 2582 LJ
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Voerendaal, 6367 ED
GSK Investigational Site
Wildervank, 9648 BE
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Zaandam, 1504 JA
GSK Investigational Site
Zwijndrecht, 3334 CL

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Belgium1 site

GSK Investigational Site
Leuven, 3000

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About this study

Read the 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.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spirometry
Keywords: COPD, exacerbation, comorbidities, lung function, burden, chronic bronchitis, emphysema, prevalence, cardiovascular disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpirometryProcedure or surgery
Assessment of lung function by spirometry

Study groups in NCT01516528
Study group	Role	What they receive
All		All subjects enrolled in the study Receives: Procedure: Spirometry

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From 15 months pre-baseline to 24 months post-baseline.
Presence and severity of cardiovascular disease.
The presence and severity pre-defined cardiovascular diseases.
Measured: From 3 months pre-baseline to 24 months post-baseline.

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201112 Jun 2015

First posted25 Jan 2012 (estimated)
Study start17 Nov 2011
Primary completion1 May 2015
Study completion12 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01516528
Sponsor's protocol ID: 115058
Acronym: ACCESS
Status last verified: Sep 2017
First submitted: 12 Jan 2012
Last updated: 20 Sep 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
ClinicalTrials.gov ID: NCT01516528
Acronym / sponsor ID: ACCESS / 115058
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, exacerbation, comorbidities, lung function, burden, chronic bronchitis, emphysema, prevalence
Study type: Observational
Recruitment status: Completed
Enrolment: 3,500 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Nov 2011
Primary completion: 1 May 2015 (actual)
Study completion: 12 Jun 2015 (actual)
First posted: 25 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All	–	Procedure: SpirometryAll subjects enrolled in the study

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care outpatients who have a an established clinical history of COPD for a minimum of 12 months.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpirometryAssessment of lung function by spirometry	Procedure or surgery	All

Primary outcome

Frequency of COPD Exacerbation
Time frame: From 15 months pre-baseline to 24 months post-baseline.
COPD exacerbations (moderate-severe severity), defined as a worsening of symptoms that require oral corticosteroids or antibiotics or hospitalization, or any combination of these.
Presence and severity of cardiovascular disease.
Time frame: From 3 months pre-baseline to 24 months post-baseline.
The presence and severity pre-defined cardiovascular diseases.

9 secondary outcomes

Presence and severity of other comorbidities
Time frame: Up to 24 months post baseline.
Spirometry
Time frame: Up to 24 months post baseline.
Health status
Time frame: Up to 24 months post baseline.
Dyspnoea
Time frame: Up to 24 months post baseline.
Number of Deaths
Time frame: up to 24 months post baseline.
Healthcare Utilisation
Time frame: Up to 24 months post baseline.
Blood Chemistry
Time frame: Up to 24 months post baseline.
Electrocardiogram
Time frame: Up to 24 months post baseline.
Bone fractures
Time frame: Within 12 months prior to baseline and up to 24 months post baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

233 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 233 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in France, Germany, Spain, Poland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of COPD Exacerbation (time frame: From 15 months pre-baseline to 24 months post-baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.