Pregnancy: Women who are pregnant or lactating. 
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD). 
alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD. 
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. 
Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant. 
A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable). 
Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD). 
Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study. 
End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal). 
Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded. 
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years. 
Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary. 
Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures. 
Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. 
Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified): 
Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day Any other investigational drug 30 days or 5 half lives whichever is longer.       
    

NCT01313676_exc_T2
Condition
Asthma
NCT01313676_exc_T3
Condition
asthma
NCT01313676_exc_T4
Temporal
current
NCT01313676_exc_T5
Temporal
prior
NCT01313676_exc_T6
Observation
history
NCT01313676_exc_T7
Condition
asthma
NCT01313676_exc_T8
Condition
COPD
NCT01313676_exc_T9
Condition
alpha 1-antitrypsin deficiency
NCT01313676_exc_T10
Condition
COPD
NCT01313676_exc_T11
Condition
alpha-1 antitrypsin deficiency
NCT01313676_exc_T12
Condition
tuberculosis
NCT01313676_exc_T13
Condition
Other respiratory disorders
NCT01313676_exc_T15
Condition
lung cancer
NCT01313676_exc_T16
Condition
bronchiectasis
NCT01313676_exc_T17
Condition
sarcoidosis
NCT01313676_exc_T18
Condition
pulmonary fibrosis
NCT01313676_exc_T19
Condition
pulmonary hypertension
NCT01313676_exc_T20
Condition
interstitial lung diseases
NCT01313676_exc_T21
Condition
active pulmonary diseases
NCT01313676_exc_T22
Scope
tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
NCT01313676_exc_T23
Procedure
Lung resection
NCT01313676_exc_T24
Procedure
transplantation
NCT01313676_exc_T25
Procedure
lung volume reduction surgery
NCT01313676_exc_T26
Temporal
within the 12 months prior to Screening
NCT01313676_exc_T27
Reference_point
Screening
NCT01313676_exc_T28
Procedure
lung transplant
NCT01313676_exc_T29
Condition
having had a lung transplant
NCT01313676_exc_T30
Condition
with lung volume reduction surgery
NCT01313676_exc_T31
Scope
with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant
NCT01313676_exc_T32
Scope
Lung resection or transplantation
NCT01313676_exc_T33
Condition
COPD exacerbation
NCT01313676_exc_T34
Qualifier
moderate
NCT01313676_exc_T35
Qualifier
severe
NCT01313676_exc_T36
Scope
moderate/severe
NCT01313676_exc_T38
Temporal
at least 14 days prior to Visit 1
NCT01313676_exc_T37
Observation
resolved
NCT01313676_exc_T39
Negation
not
NCT01313676_exc_T40
Temporal
at least 30 days following the last dose of oral corticosteroids
NCT01313676_exc_T41
Reference_point
the last dose of oral corticosteroids
NCT01313676_exc_T42
Condition
heart failure
NCT01313676_exc_T43
Qualifier
severe
NCT01313676_exc_T44
Measurement
New York Heart Association
NCT01313676_exc_T45
Value
class IV
NCT01313676_exc_T46
Measurement
ejection fraction
NCT01313676_exc_T47
Value
<30%
NCT01313676_exc_T48
Device
implantable cardioverter defibrillator (ICD)
NCT01313676_exc_T49
Observation
life expectancy
NCT01313676_exc_T50
Value
<3 years
NCT01313676_exc_T51
Condition
life-threatening condition
NCT01313676_exc_T52
Condition
vascular disease
NCT01313676_exc_T53
Condition
COPD
NCT01313676_exc_T55
Negation
other than
NCT01313676_exc_T56
Scope
vascular disease or COPD
NCT01313676_exc_T57
Condition
End stage chronic renal disease
NCT01313676_exc_T58
Procedure
renal replacement therapy
NCT01313676_exc_T59
Procedure
hemodialysis
NCT01313676_exc_T60
Qualifier
peritoneal
NCT01313676_exc_T61
Scope
hemodialysis or peritoneal
NCT01313676_exc_T62
Condition
Drug allergy
NCT01313676_exc_T63
Condition
food allergy
NCT01313676_exc_T64
Condition
hypersensitivity
NCT01313676_exc_T65
Drug
beta-agonists
NCT01313676_exc_T66
Drug
corticosteroid
NCT01313676_exc_T67
Drug
study medications
NCT01313676_exc_T69
Scope
beta-agonists, corticosteroid
NCT01313676_exc_T70
Drug
components of the inhalation powder
NCT01313676_exc_T71
Drug
lactose
NCT01313676_exc_T72
Drug
magnesium stearate
NCT01313676_exc_T73
Scope
lactose, magnesium stearate
NCT01313676_exc_T74
Scope
study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate)
NCT01313676_exc_T75
Condition
milk protein allergy
NCT01313676_exc_T76
Qualifier
severe
NCT01313676_exc_T77
Observation
history
NCT01313676_exc_T79
Drug
alcohol abuse
NCT01313676_exc_T80
Drug
Drug abuse
NCT01313676_exc_T81
Observation
history
NCT01313676_exc_T82
Drug
drug abuse
NCT01313676_exc_T83
Drug
alcohol abuse
NCT01313676_exc_T84
Temporal
within the last 2 years
NCT01313676_exc_T85
Scope
alcohol or drug abuse
NCT01313676_exc_T86
Procedure
long-term oxygen therapy (LTOT)
NCT01313676_exc_T87
Procedure
nocturnal oxygen therapy
NCT01313676_exc_T88
Multiplier
greater than 12 hours a day
NCT01313676_exc_T89
Scope
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy
NCT01313676_exc_T94
Drug
Inhaled Long acting beta-agonists (LABA)
NCT01313676_exc_T95
Temporal
48 hours
NCT01313676_exc_T96
Reference_point
Screening
NCT01313676_exc_T97
Drug
ICS/LABA combination products
NCT01313676_exc_T98
Temporal
48 hours
NCT01313676_exc_T99
Drug
Inhaled corticosteroids
NCT01313676_exc_T100
Temporal
48 hours
NCT01313676_exc_T101
Drug
Tiotropium
NCT01313676_exc_T102
Temporal
1 week
NCT01313676_exc_T103
Drug
corticosteroids
NCT01313676_exc_T104
Qualifier
Systemic
NCT01313676_exc_T105
Qualifier
Oral
NCT01313676_exc_T106
Qualifier
parenteral
NCT01313676_exc_T107
Qualifier
intra-articular
NCT01313676_exc_T108
Scope
Systemic, Oral, parenteral, intra-articular
NCT01313676_exc_T109
Temporal
30 days
NCT01313676_exc_T110
Drug
corticosteroids
NCT01313676_exc_T111
Qualifier
oral
NCT01313676_exc_T112
Qualifier
systemic
NCT01313676_exc_T113
Scope
oral and systemic
NCT01313676_exc_T114
Condition
COPD exacerbations
NCT01313676_exc_T115
Procedure
treat COPD exacerbations
NCT01313676_exc_T116
Temporal
during the study
NCT01313676_exc_T117
Reference_point
the study
NCT01313676_exc_T119
Drug
Cytochrome P450 3A4 strong inhibitors
NCT01313676_exc_T120
Drug
Itraconazole
NCT01313676_exc_T121
Drug
Clarithromycin
NCT01313676_exc_T122
Drug
Telithromycin
NCT01313676_exc_T123
Drug
Amiodarone
NCT01313676_exc_T124
Drug
Nefazodone
NCT01313676_exc_T125
Temporal
6 weeks
NCT01313676_exc_T126
Drug
Grapefruit
NCT01313676_exc_T128
Drug
investigational drug
NCT01313676_exc_T130
Temporal
30 days
NCT01313676_exc_T131
Temporal
5 half lives
NCT01313676_exc_T132
Scope
30 days or 5 half lives
NCT01313676_exc_T133
Drug
antiretrovirals
NCT01313676_exc_T134
Drug
protease inhibitors
NCT01313676_exc_T135
Drug
Indinavir
NCT01313676_exc_T136
Drug
Nelfinavir
NCT01313676_exc_T137
Drug
Ritonavir
NCT01313676_exc_T138
Drug
Saquinavir
NCT01313676_exc_T139
Scope
Indinavir, Nelfinavir, Ritonavir, Saquinavir
NCT01313676_exc_T140
Drug
Imidazole anti-fungals
NCT01313676_exc_T141
Drug
Triazole anti-fungals
NCT01313676_exc_T142
Drug
Ketaconazole
NCT01313676_exc_T143
Scope
Imidazole and Triazole anti-fungals
NCT01313676_exc_T144
Scope
Ketaconazole, Itraconazole
NCT01313676_exc_T145
Scope
antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone
NCT01313676_exc_T146
Negation
No
NCT01313676_exc_T147
Reference_point
any time during the study