written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
persistent asthma
Item
diagnosis of persistent bronchial asthma (with reference to the global initiative for asthma guidelines 2002)
boolean
C3266628 (UMLS CUI [1])
fev1
Item
baseline fev1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, dscg, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
boolean
C0748133 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
fev1
Item
baseline fev1 60 - 90% in patients receiving not more than 500 mcg bdp-cfc (or equivalent) and/or in combination with any other asthma medication mentioned above
boolean
C0748133 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
no change in asthma treatment
Item
no change in the asthma treatment 4 weeks prior to baseline period
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
health status
Item
patients who, with the exception of asthma, are in good health
boolean
C0018759 (UMLS CUI [1])
poorly controlled asthma
Item
poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
boolean
C0004096 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0744425 (UMLS CUI [4])
rescue medication
Item
patient using regularly >8 puffs/day rescue medication prior to baseline
boolean
C0013227 (UMLS CUI [1])
history of lower airway infection
Item
history of lower airway infection in the last 4 weeks prior to baseline period
boolean
C0009450 (UMLS CUI [1,1])
C0458827 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
smoking history
Item
heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of ≥10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
abnormal laboratory values
Item
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
boolean
C1254595 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
liver insufficiency
Item
liver insufficiency (child pugh a or worse)
boolean
C1306571 (UMLS CUI [1])
active hepatitis
Item
active hepatitis
boolean
C0205177 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
hiv infection
Item
known infection with hiv
boolean
C0019682 (UMLS CUI [1])
cancer
Item
diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
alcohol and/or drug abuse
Item
alcohol and/or drug abuse
boolean
C0038586 (UMLS CUI [1])
hypersensitivity to study medication
Item
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
boolean
C0020517 (UMLS CUI [1,1])
C0965618 (UMLS CUI [1,2])
pregnancy, childbearing potential, lack of contraception
Item
pregnancy or patient of childbearing potential who is not using reliable method of contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
compliance behavior
Item
patients not able to follow study procedures, e.g. due to language problems, psychological disorders
boolean
C1321605 (UMLS CUI [1])
suspected inability or unwillingness to comply with the study procedures
Item
suspected inability or unwillingness to comply with the study procedures
boolean
C1321605 (UMLS CUI [1])