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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01516528
Collaborator
(none)
3,500
Enrollment
233
Locations
42.8
Duration (Months)
15
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spirometry

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.

Study Design

Study Type:
Observational
Actual Enrollment :
3500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care
Study Start Date :
Nov 17, 2011
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Jun 12, 2015

Arms and Interventions

Arm Intervention/Treatment
All

All subjects enrolled in the study

Procedure: Spirometry
Assessment of lung function by spirometry

Outcome Measures

Primary Outcome Measures

  1. Frequency of COPD Exacerbation [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.

  2. Presence and severity of cardiovascular disease. [From 3 months pre-baseline to 24 months post-baseline.]

    The presence and severity pre-defined cardiovascular diseases.

Secondary Outcome Measures

  1. Presence and severity of other comorbidities [Up to 24 months post baseline.]

    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) .

  2. Spirometry [Up to 24 months post baseline.]

    Post-bronchodilator FEV1 and forced vital capacity (FVC), FEV1/FVC ratio and FEV1 % of predicted.

  3. Health status [Up to 24 months post baseline.]

    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).

  4. Dyspnoea [Up to 24 months post baseline.]

    As determined by the modified Medical Research Council (mMRC) scale.

  5. Number of Deaths [up to 24 months post baseline.]

    Patients who die during the study, including the reason for death, where known.

  6. Healthcare Utilisation [Up to 24 months post baseline.]

    Number of unscheduled GP contacts and Hospitalisations

  7. Blood Chemistry [Up to 24 months post baseline.]

    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

  8. Electrocardiogram [Up to 24 months post baseline.]

    Assessment of normal or abnormal readings. Qualitative description and QT interval.

  9. Bone fractures [Within 12 months prior to baseline and up to 24 months post baseline]

    The number and location of bone fractures.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Leuven Belgium 3000
2 GSK Investigational Site Angers cedex 9 France 49933
3 GSK Investigational Site Angers France 49000
4 GSK Investigational Site Angers France 49100
5 GSK Investigational Site Aumetz France 57710
6 GSK Investigational Site Beziers France 34500
7 GSK Investigational Site Blois France 41000
8 GSK Investigational Site Bordeaux France 33200
9 GSK Investigational Site Bouliac France 33270
10 GSK Investigational Site Bourg Des Comptes France 35890
11 GSK Investigational Site Briollay France 49125
12 GSK Investigational Site Carbon Blanc France 33650
13 GSK Investigational Site Carbonne France 31390
14 GSK Investigational Site Chatellerault France 86100
15 GSK Investigational Site Chatou France 78400
16 GSK Investigational Site Cholet France 49300
17 GSK Investigational Site Chollet France 49300
18 GSK Investigational Site Couzeix France 87270
19 GSK Investigational Site Cugnaux France 31270
20 GSK Investigational Site Dinard France 35800
21 GSK Investigational Site Donges France 44480
22 GSK Investigational Site Escoublac France 44500
23 GSK Investigational Site Franconville France 95130
24 GSK Investigational Site Gemozac France 17260
25 GSK Investigational Site Grandchamps France 56390
26 GSK Investigational Site Haute Goulaine France 44115
27 GSK Investigational Site Houilles France 78800
28 GSK Investigational Site La Bouexiere France 35340
29 GSK Investigational Site La Fresnais France 35111
30 GSK Investigational Site La Fôret sur Sèvres France 79380
31 GSK Investigational Site La Jubaudière France 49510
32 GSK Investigational Site La Montagne France 44620
33 GSK Investigational Site La Riche France 37250
34 GSK Investigational Site La Rochelle France 17000
35 GSK Investigational Site La Teste de Buch France 33260
36 GSK Investigational Site La Varenne France 49270
37 GSK Investigational Site Le Bono France 56400
38 GSK Investigational Site Le Fousseret France 31430
39 GSK Investigational Site Le Mesnil en Vallée France 49410
40 GSK Investigational Site Les Ponts de Cé France 49130
41 GSK Investigational Site Liffre France 35340
42 GSK Investigational Site Limoges France 87000
43 GSK Investigational Site Limoges France 87100
44 GSK Investigational Site Louvigne de Bais France 35680
45 GSK Investigational Site Marseille France 13009
46 GSK Investigational Site Martin Eglise France 76370
47 GSK Investigational Site Montreuil Juigne France 49460
48 GSK Investigational Site Montrevault France 49110
49 GSK Investigational Site Mouliherne France 49390
50 GSK Investigational Site Moulins les Metz France 57160
51 GSK Investigational Site Muret France 31600
52 GSK Investigational Site Murs-Erigne France 49610
53 GSK Investigational Site Nantes France 44000
54 GSK Investigational Site Nantes France 44300
55 GSK Investigational Site Nexon France 87800
56 GSK Investigational Site Nieul sur Mer France 17137
57 GSK Investigational Site Parcay les Pins France 49390
58 GSK Investigational Site Paris France 75011
59 GSK Investigational Site Paris France 75013
60 GSK Investigational Site Paris France 75019
61 GSK Investigational Site Paris France 75020
62 GSK Investigational Site Perigny France 17180
63 GSK Investigational Site Pont à Mousson France 54700
64 GSK Investigational Site Rennes France 35000
65 GSK Investigational Site Rosiers d'Egletons France 19300
66 GSK Investigational Site Royan France 17200
67 GSK Investigational Site Saint Aubin des Chateaux France 44110
68 GSK Investigational Site Saint Cyr sur Loire France 37540
69 GSK Investigational Site Saint Etienne de Montluc France 44360
70 GSK Investigational Site Saint Georges de Montaigu France 85600
71 GSK Investigational Site Saint Herblain France 44800
72 GSK Investigational Site Saint Jouan des Guerets France 35430
73 GSK Investigational Site Saint Malo France 35400
74 GSK Investigational Site Saint Max France 54130
75 GSK Investigational Site Saint Médard en Jalles France 33160
76 GSK Investigational Site Saint Orens de Gameville France 31650
77 GSK Investigational Site Saint Pierre en Val France 76260
78 GSK Investigational Site Saint-Etienne France 42100
79 GSK Investigational Site Saint-Loubès France 33450
80 GSK Investigational Site Sarrebourg France 57400
81 GSK Investigational Site Savonnières France 37510
82 GSK Investigational Site Scorbe Clairvaux France 86140
83 GSK Investigational Site Segré France 49500
84 GSK Investigational Site Seysses France 31600
85 GSK Investigational Site Thionville France 57100
86 GSK Investigational Site Thouars France 79100
87 GSK Investigational Site Tierce France 49125
88 GSK Investigational Site Toulouse France 31200
89 GSK Investigational Site Tours France 37000
90 GSK Investigational Site Tours France 37100
91 GSK Investigational Site Vannes France 56000
92 GSK Investigational Site Verzy France 51380
93 GSK Investigational Site Vihiers France 49310
94 GSK Investigational Site Villey Saint Etienne France 54200
95 GSK Investigational Site Vitré France 35500
96 GSK Investigational Site Vue France 44640
97 GSK Investigational Site Witry les Reims France 51420
98 GSK Investigational Site Yerres France 91330
99 GSK Investigational Site Bruchsal Baden-Wuerttemberg Germany 76646
100 GSK Investigational Site Ettlingen Baden-Wuerttemberg Germany 76275
101 GSK Investigational Site Mannheim Baden-Wuerttemberg Germany 68161
102 GSK Investigational Site Messkirch Baden-Wuerttemberg Germany 88605
103 GSK Investigational Site Sinsheim Baden-Wuerttemberg Germany 74889
104 GSK Investigational Site Weinheim Baden-Wuerttemberg Germany 69469
105 GSK Investigational Site Bad Woerrishofen Bayern Germany 86825
106 GSK Investigational Site Muenchen Bayern Germany 80335
107 GSK Investigational Site Potsdam Brandenburg Germany 14469
108 GSK Investigational Site Potsdam Brandenburg Germany 14478
109 GSK Investigational Site Bensheim Hessen Germany 64625
110 GSK Investigational Site Floersheim Hessen Germany 65439
111 GSK Investigational Site Kelkheim Hessen Germany 65779
112 GSK Investigational Site Neu-Isenburg Hessen Germany 63263
113 GSK Investigational Site Offenbach Hessen Germany 63071
114 GSK Investigational Site Hannover Niedersachsen Germany 30159
115 GSK Investigational Site Wardenburg Niedersachsen Germany 26203
116 GSK Investigational Site Bonn Nordrhein-Westfalen Germany 53119
117 GSK Investigational Site Dueren Nordrhein-Westfalen Germany 52349
118 GSK Investigational Site Essen Nordrhein-Westfalen Germany 45359
119 GSK Investigational Site Goch Nordrhein-Westfalen Germany 47574
120 GSK Investigational Site Hagen Nordrhein-Westfalen Germany 58095
121 GSK Investigational Site Harsewinkel Nordrhein-Westfalen Germany 33428
122 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 51069
123 GSK Investigational Site Rheine Nordrhein-Westfalen Germany 48431
124 GSK Investigational Site Solingen Nordrhein-Westfalen Germany 42651
125 GSK Investigational Site Witten Nordrhein-Westfalen Germany 58452
126 GSK Investigational Site Ingelheim Rheinland-Pfalz Germany 55218
127 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55116
128 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55128
129 GSK Investigational Site Nussbach Rheinland-Pfalz Germany 67759
130 GSK Investigational Site Koethen Sachsen-Anhalt Germany 06366
131 GSK Investigational Site Zerbst Sachsen-Anhalt Germany 39261
132 GSK Investigational Site Dresden Sachsen Germany 01069
133 GSK Investigational Site Riesa Sachsen Germany 01587
134 GSK Investigational Site Bad Segeberg Schleswig-Holstein Germany 23795
135 GSK Investigational Site Luebeck Schleswig-Holstein Germany 23554
136 GSK Investigational Site Luebeck Schleswig-Holstein Germany 23562
137 GSK Investigational Site Reinfeld Schleswig-Holstein Germany 23858
138 GSK Investigational Site Berlin Germany 10555
139 GSK Investigational Site Berlin Germany 14052
140 GSK Investigational Site Hamburg Germany 22143
141 GSK Investigational Site Andijk Netherlands 1619XK
142 GSK Investigational Site Beek En Donk Netherlands 5741 CG
143 GSK Investigational Site Den Bosch Netherlands 5235 KG
144 GSK Investigational Site Den Haag Netherlands 2517 EW
145 GSK Investigational Site Den Haag Netherlands 2582 LJ
146 GSK Investigational Site Deurne Netherlands 5751 XJ
147 GSK Investigational Site Eersel Netherlands 5521 WD
148 GSK Investigational Site Enschede Netherlands 7544 BA
149 GSK Investigational Site Ermelo Netherlands 3851 EX
150 GSK Investigational Site Hoogwoud Netherlands 1718 BG
151 GSK Investigational Site Kloosterhaar Netherlands 7694 AC
152 GSK Investigational Site Lieshout Netherlands 5737 CB
153 GSK Investigational Site Musselkanaal Netherlands 9581 AJ
154 GSK Investigational Site Nijverdal Netherlands 7442 LS
155 GSK Investigational Site Soerendonk Netherlands 6027 PL
156 GSK Investigational Site Spijkenisse Netherlands 3207 NB
157 GSK Investigational Site Voerendaal Netherlands 6367 ED
158 GSK Investigational Site Wildervank Netherlands 9648 BE
159 GSK Investigational Site Zaandam Netherlands 1504 JA
160 GSK Investigational Site Zwijndrecht Netherlands 3334 CL
161 GSK Investigational Site Bydgoszcz Poland 85-046
162 GSK Investigational Site Bydgoszcz Poland 85-796
163 GSK Investigational Site Bydgoszcz Poland 85-863
164 GSK Investigational Site Czestochowa Poland 42-200
165 GSK Investigational Site Domaradz Poland 36-230
166 GSK Investigational Site Elblag Poland 82-300
167 GSK Investigational Site Jaslo Poland 38-200
168 GSK Investigational Site Katowice Poland 40-055
169 GSK Investigational Site Katowice Poland 40-645
170 GSK Investigational Site Katowice Poland 40-750
171 GSK Investigational Site Katowice Poland 40-954
172 GSK Investigational Site Krakow Poland 30-015
173 GSK Investigational Site Krakow Poland 30-053
174 GSK Investigational Site Krakow Poland 30-347
175 GSK Investigational Site Krakow Poland 31-637
176 GSK Investigational Site Libiaz Poland 32-590
177 GSK Investigational Site Lodz Poland 90-265
178 GSK Investigational Site Lublin Poland 20-854
179 GSK Investigational Site Mielec Poland 39-300
180 GSK Investigational Site Oswiecim Poland 32-600
181 GSK Investigational Site Pulawy Poland 24-100
182 GSK Investigational Site Radom Poland
183 GSK Investigational Site Radziszow Poland 32-052
184 GSK Investigational Site Rzeszow Poland 35-055
185 GSK Investigational Site Rzeszow Poland 35-068
186 GSK Investigational Site Tarnow Poland 33-100
187 GSK Investigational Site Torun Poland 87-100
188 GSK Investigational Site Warszawa Poland 01-231
189 GSK Investigational Site Warszawa Poland 01-868
190 GSK Investigational Site Wroclaw Poland 50-127
191 GSK Investigational Site Wroclaw Poland 50-349
192 GSK Investigational Site Zabrze Poland 41-800
193 GSK Investigational Site Zgierz Poland 95-100
194 GSK Investigational Site Zglobien Poland 36-046
195 GSK Investigational Site Algeciras Spain 11205
196 GSK Investigational Site Alicante Spain 03005
197 GSK Investigational Site Baracaldo Spain 48903
198 GSK Investigational Site Barcelona Spain 08018
199 GSK Investigational Site Barcelona Spain 08023
200 GSK Investigational Site Barcelona Spain 08028
201 GSK Investigational Site Barcelona Spain 08033
202 GSK Investigational Site Barcelona Spain 08034
203 GSK Investigational Site Barcelona Spain 08041
204 GSK Investigational Site Barcelona Spain 8025
205 GSK Investigational Site Benidor / Alicante Spain 03503
206 GSK Investigational Site Canet de Mar - Barcelona Spain 08360
207 GSK Investigational Site Colloto - Oviedo Spain 33010
208 GSK Investigational Site Cornellá de Llobregat-Barcelona Spain 08940
209 GSK Investigational Site Culleredo - La Coruña Spain 15670
210 GSK Investigational Site El Puerto de Santa María-Cádiz Spain 11500
211 GSK Investigational Site Fuenlabrada / Madrid Spain 28943
212 GSK Investigational Site Gijón. Asturias. Spain 33213
213 GSK Investigational Site Gijón Spain 33211
214 GSK Investigational Site Gijón Spain 33212
215 GSK Investigational Site Güeñes - Vizcaya Spain 48830
216 GSK Investigational Site Hostalric - Gerona Spain 17450
217 GSK Investigational Site La Coruña Spain 15008
218 GSK Investigational Site La Roca del Valles (Barcelona) Spain 08430
219 GSK Investigational Site Les Franqueses del Vallés - Barcelona Spain 08530
220 GSK Investigational Site Madrid Spain 28700
221 GSK Investigational Site Mataró. Barcelona. Spain 08302
222 GSK Investigational Site Mataró Spain 08303
223 GSK Investigational Site Murcia Spain 30010
224 GSK Investigational Site Málaga Spain 29014
225 GSK Investigational Site Oviedo Spain 33009
226 GSK Investigational Site Oviedo Spain
227 GSK Investigational Site peralada( Girona) Spain 17491
228 GSK Investigational Site Petrer/Alicante Spain 03610
229 GSK Investigational Site Portugalete - Vizcaya Spain 48920
230 GSK Investigational Site San Juan Spain
231 GSK Investigational Site Santa Coloma de Gramanet - Barcelona Spain 08924
232 GSK Investigational Site Valencia Spain 46021
233 GSK Investigational Site Valencia Spain

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01516528
Other Study ID Numbers:
  • 115058
First Posted:
Jan 25, 2012
Last Update Posted:
Sep 20, 2017
Last Verified:
Sep 1, 2017
Keywords provided by GlaxoSmithKline
COPD
exacerbation
comorbidities
lung function
burden
chronic bronchitis
emphysema
prevalence
cardiovascular disease
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Sep 20, 2017