Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria. 
Male or female subjects, aged >=40 years. Females must be of Non Child Bearing Potential. The definition of Non Child Bearing Potential is as following: Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal. 
Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator Forced Expiratory Volume, measured at 1 second (FEV1) <50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (IVC) ratio <70%. 
Have experienced at least 2 moderate or severe COPD exacerbations leading to medical consultation (requiring oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding Visit 1. 
Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication). 
Current or ex-smokers with a smoking history of at least 10 pack years (number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). 
Are currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale. 
A signed and dated written informed consent is obtained prior to participation. 
Able to comply with the requirements of the protocol and be available for study visits over 52 weeks. 

NCT00527826_inc_T1
Condition
COPD
NCT00527826_inc_T2
Measurement
American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria
NCT00527826_inc_T3
Value
>=40 years
NCT00527826_inc_T4
Person
aged
NCT00527826_inc_T5
Person
Male
NCT00527826_inc_T6
Person
female
NCT00527826_inc_T7
Person
Females
NCT00527826_inc_T8
Condition
Child Bearing Potential
NCT00527826_inc_T9
Negation
Non
NCT00527826_inc_T10
Condition
Child Bearing Potential
NCT00527826_inc_T11
Negation
Non
NCT00527826_inc_T12
Person
Females
NCT00527826_inc_T13
Condition
functioning ovaries
NCT00527826_inc_T14
Condition
tubal ligation
NCT00527826_inc_T15
Condition
hysterectomy
NCT00527826_inc_T17
Condition
post-menopausal
NCT00527826_inc_T16
Person
females
NCT00527826_inc_T18
Scope
Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy
NCT00527826_inc_T19
Scope
females who are post-menopausal
NCT00527826_inc_T20
Scope
Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal
NCT00527826_inc_T21
Scope
Non Child Bearing Potential
NCT00527826_inc_T22
Condition
COPD
NCT00527826_inc_T23
Value
stage III or IV
NCT00527826_inc_T24
Measurement
GOLD criteria
NCT00527826_inc_T25
Measurement
Forced Expiratory Volume, measured at 1 second (FEV1)
NCT00527826_inc_T26
Value
<50% of predicted normal
NCT00527826_inc_T27
Temporal
post-bronchodilator
NCT00527826_inc_T28
Temporal
post- bronchodilator
NCT00527826_inc_T29
Measurement
FEV1/Inspiratory Vital Capacity (IVC) ratio
NCT00527826_inc_T30
Value
<70%
NCT00527826_inc_T31
Multiplier
at least 2
NCT00527826_inc_T32
Qualifier
severe
NCT00527826_inc_T33
Qualifier
moderate
NCT00527826_inc_T34
Condition
COPD exacerbations
NCT00527826_inc_T35
Scope
moderate or severe
NCT00527826_inc_T36
Drug
oral corticosteroids
NCT00527826_inc_T37
Drug
oral corticosteroids
NCT00527826_inc_T38
Qualifier
increasing dosage
NCT00527826_inc_T39
Drug
antibiotics
NCT00527826_inc_T40
Visit
hospitalization
NCT00527826_inc_T41
Temporal
within the 12 months preceding Visit 1
NCT00527826_inc_T42
Scope
oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization
NCT00527826_inc_T43
Drug
COPD medication
NCT00527826_inc_T44
Temporal
within 4 weeks prior to Visit 1
NCT00527826_inc_T45
Qualifier
stable
NCT00527826_inc_T46
Condition
smokers
NCT00527826_inc_T47
Measurement
smoking history
NCT00527826_inc_T48
Value
10 pack years
NCT00527826_inc_T49
Scope
number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years
NCT00527826_inc_T52
Temporal
Current
NCT00527826_inc_T53
Negation
ex
NCT00527826_inc_T54
Scope
Current or ex
NCT00527826_inc_T55
Observation
managed at home
NCT00527826_inc_T56
Visit
at home
NCT00527826_inc_T57
Procedure
managed
NCT00527826_inc_T58
Observation
outpatients
NCT00527826_inc_T59
Visit
outpatients
NCT00527826_inc_T51
Condition
ambulatory
NCT00527826_inc_T60
Observation
able to travel to the clinic
NCT00527826_inc_T61
Observation
written informed consent
NCT00527826_inc_T62
Temporal
prior to participation
NCT00527826_inc_T50
Observation
Able to comply with the requirements of the protocol
NCT00527826_inc_T63
Observation
available for study visits
NCT00527826_inc_T64
Visit
study visits
NCT00527826_inc_T65
Temporal
over 52 weeks
NCT00527826_inc_T66
Drug
COPD medication
NCT00527826_inc_T67
Drug
vaccines
NCT00527826_inc_T68
Drug
inhaled short-acting beta-2-agonists
NCT00527826_inc_T69
Drug
short-acting
NCT00527826_inc_T70
Drug
long-acting anticholinergics
NCT00527826_inc_T71
Drug
tiotropium
NCT00527826_inc_T72
Drug
systemic beta-2-agonists
NCT00527826_inc_T73
Drug
theophylline
NCT00527826_inc_T74
Drug
mucolytics
NCT00527826_inc_T75
Drug
antioxidants
NCT00527826_inc_T76
Drug
beta-1-agonists
NCT00527826_inc_T78
Condition
cardiovascular indication
NCT00527826_inc_T77
Condition
non-invasive ventilation
NCT00527826_inc_T79
Multiplier
long term
NCT00527826_inc_T80
Procedure
oxygen therapy
NCT00527826_inc_T81
Drug
oxygen
NCT00527826_inc_T82
Condition
Cor Pulmonale
NCT00527826_inc_T83
Scope
COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants