FEV1 >= 80% or FEV1 < 20% of predicted value post-bronchodilator. 
FEV1/SVC>=70% 
History of lung transplant. 
Any lung surgery within the past two years. 
On any thoracic surgery waiting list. 
End of last exacerbation less than 6 weeks prior to screening/re-screening visit. 
Clinically significant intercurrent illnesses (except for respiratory or liver disease secondary to AAT deficiency), including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could possibly be included after consultation with the treating physician and the sponsor. 
Active smoking during the last 12 months from screening date. 
Pregnancy or lactation. 
Woman of child-bearing potential not taking adequate contraception deemed reliable by the investigator. 
Presence of psychiatric/ mental disorder or any other medical disorder which might impair the patient's ability to give informed consent or to comply with the requirements of the study protocol. 
Evidence of ongoing viral infection with HCV, HBV and/or HIV. 
Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs. 
IgA Deficiency 
History of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products. 
Participation in another clinical trial within 30 days prior to baseline visit. 
Inability to attend scheduled clinic visits and/or comply with the study protocol. 
Any other factor that, in the opinion of the investigator, would prevent the patient from complying with the requirements of the protocol.       
    

NCT01217671_exc_T1
Measurement
FEV1
NCT01217671_exc_T2
Value
>= 80%
NCT01217671_exc_T3
Measurement
FEV1
NCT01217671_exc_T4
Value
< 20% of predicted value
NCT01217671_exc_T5
Qualifier
post-bronchodilator
NCT01217671_exc_T6
Temporal
post-bronchodilator
NCT01217671_exc_T7
Drug
bronchodilator
NCT01217671_exc_T8
Reference_point
bronchodilator
NCT01217671_exc_T9
Measurement
FEV1/SVC
NCT01217671_exc_T10
Value
>=70%
NCT01217671_exc_T11
Procedure
lung transplant
NCT01217671_exc_T12
Observation
History
NCT01217671_exc_T13
Procedure
lung surgery
NCT01217671_exc_T14
Temporal
within the past two years
NCT01217671_exc_T15
Procedure
thoracic surgery
NCT01217671_exc_T16
Observation
thoracic surgery waiting list
NCT01217671_exc_T17
Condition
exacerbation
NCT01217671_exc_T18
Temporal
less than 6 weeks prior to screening/re-screening visit
NCT01217671_exc_T19
Reference_point
screening/re-screening visit
NCT01217671_exc_T20
Condition
intercurrent illnesses
NCT01217671_exc_T21
Qualifier
Clinically significant
NCT01217671_exc_T24
Negation
except for
NCT01217671_exc_T25
Condition
respiratory disease
NCT01217671_exc_T26
Condition
liver disease
NCT01217671_exc_T27
Qualifier
secondary to AAT deficiency
NCT01217671_exc_T28
Condition
AAT deficiency
NCT01217671_exc_T29
Scope
respiratory or liver disease
NCT01217671_exc_T30
Condition
cardiac
NCT01217671_exc_T31
Condition
hepatic
NCT01217671_exc_T32
Condition
renal
NCT01217671_exc_T33
Condition
endocrine
NCT01217671_exc_T34
Condition
neurological
NCT01217671_exc_T35
Condition
hematological
NCT01217671_exc_T36
Condition
neoplastic
NCT01217671_exc_T37
Condition
immunological
NCT01217671_exc_T38
Condition
skeletal
NCT01217671_exc_T39
Condition
other
NCT01217671_exc_T41
Scope
cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other
NCT01217671_exc_T44
Condition
Active smoking
NCT01217671_exc_T45
Temporal
Active
NCT01217671_exc_T46
Temporal
during the last 12 months from screening date
NCT01217671_exc_T47
Reference_point
screening date
NCT01217671_exc_T48
Condition
Pregnancy
NCT01217671_exc_T49
Condition
lactation
NCT01217671_exc_T50
Person
Woman
NCT01217671_exc_T51
Condition
child-bearing potential
NCT01217671_exc_T52
Procedure
contraception
NCT01217671_exc_T53
Qualifier
adequate
NCT01217671_exc_T56
Negation
not
NCT01217671_exc_T57
Scope
Woman of child-bearing potentia
NCT01217671_exc_T58
Qualifier
deemed reliable by the investigator
NCT01217671_exc_T60
Condition
psychiatric disorder
NCT01217671_exc_T61
Condition
mental disorder
NCT01217671_exc_T62
Condition
other medical disorder
NCT01217671_exc_T64
Observation
impair the patient's ability to give informed consent
NCT01217671_exc_T66
Scope
psychiatric/ mental disorder or any other medical disorder
NCT01217671_exc_T67
Condition
viral infection
NCT01217671_exc_T68
Condition
HCV
NCT01217671_exc_T69
Condition
HBV
NCT01217671_exc_T70
Condition
HIV
NCT01217671_exc_T71
Scope
HCV, HBV and/or HIV
NCT01217671_exc_T72
Temporal
ongoing
NCT01217671_exc_T73
Condition
alcohol abuse
NCT01217671_exc_T74
Condition
alcohol abuse
NCT01217671_exc_T75
Observation
history
NCT01217671_exc_T76
Condition
abuse illegal drugs
NCT01217671_exc_T77
Condition
abuse legally prescribed drugs
NCT01217671_exc_T78
Scope
alcohol abuse or illegal and/or legally prescribed drugs
NCT01217671_exc_T79
Condition
IgA Deficiency
NCT01217671_exc_T80
Condition
life threatening allergy
NCT01217671_exc_T81
Qualifier
life threatening
NCT01217671_exc_T82
Condition
anaphylactic reaction
NCT01217671_exc_T83
Condition
systemic response to human plasma derived products
NCT01217671_exc_T84
Qualifier
human plasma derived
NCT01217671_exc_T85
Drug
products
NCT01217671_exc_T86
Observation
History
NCT01217671_exc_T87
Scope
life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products