written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
persistent asthma
Item
diagnosis of persistent chronic bronchial asthma, according to global initiative for asthma (gina) guidelines
boolean
C3266628 (UMLS CUI [1])
bdp-cfc
Item
the patient has been receiving bdp - cfc ≤1000 mcg per day or equivalent for the previous four weeks
boolean
fev1
Item
fev1 between 60 and 90% predicted at visit 1
boolean
C0748133 (UMLS CUI [1])
no change in asthma treatment
Item
no change in asthma treatment within 4 weeks prior to visit 1
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
poorly controlled asthma
Item
patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
boolean
C3853134 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0744425 (UMLS CUI [4])
seasonal asthma
Item
patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
boolean
C0004096 (UMLS CUI [1])
C0349790 (UMLS CUI [2])
lower airway infection
Item
a history of lower airway infection in the four weeks prior to visit 1
boolean
C0009450 (UMLS CUI [1,1])
C0458827 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
a diagnosis of chronic obstructive pulmonary disease (copd) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
boolean
C0024117 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
smoking history
Item
heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
relief medication
Item
patients using >8 puffs/day relief medication regularly prior to visit 1
boolean
C0013227 (UMLS CUI [1])
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])
cancer history
Item
a diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
boolean
C1512706 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
nyha
Item
patients with chronic heart failure class iii or iv (new york heart association)
boolean
C1275491 (UMLS CUI [1])
hypersensitivity to any ingredients of the study medication
Item
suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, bdp, or salbutamol)
boolean
C0020517 (UMLS CUI [1,1])
C0965618 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001927 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004906 (UMLS CUI [3,2])
substance use disorder
Item
a history of alcoholism or substance abuse within the 12 months prior to visit 1
boolean
C0038586 (UMLS CUI [1])
pregnancy, childbearing potential, lack of contraception
Item
pregnancy or women of childbearing potential who are not using a reliable method of contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])