Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Written informed consent
Item
Has a signed and dated written informed consent been obtained prior to study participation?
boolean
C0021430 (UMLS CUI [1])
Age
Item
Is the subject aged 18-65 years (inclusive)?
boolean
C0001779 (UMLS CUI [1])
BMI
Item
Does the subject have a Body Mass Index within the range of 19 to 30 kg.m-2 inclusive?
boolean
C1305855 (UMLS CUI [1])
Gender
Item
Is the subject male or an eligible female?
boolean
C0079399 (UMLS CUI [1])
Asthma, required treatment
Item
Does the subject have a history of asthma of at least 6 months duration, and has required treatment over the 6 months preceding screening?
boolean
C0004096 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Mild/intermittent asthma, PEF, FEV1
Item
Does the subject have mild or intermittent asthma and has a best (maximum) screening peak expiratory flow (PEF) and Forced Expiratory Volume in 1 second (FEV1) of > 80% predicted after withholding all asthma edications for 6 hours?
boolean
C2945599 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0205267 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0521299 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0748133 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Current inhaled steroids (BDP or equivalent, not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol
Item
Is the subject currently taking inhaled steroids ( up to 800mcg per day of BDP or equivalent but not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol, and has the subject remained on a fixed regimen for at least 4 weeks before screening?
boolean
C0521116 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0004906 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0082607 (UMLS CUI [3,3])
C0086073 (UMLS CUI [4])
C0068483 (UMLS CUI [5])
C0595726 (UMLS CUI [6])
C0001927 (UMLS CUI [7])
Lifetime non-smoker, ex-smoker
Item
Is the subject a lifetime non-smoker or an ex-smoker of >1 year duration with a <5 year pack history?
boolean
C4071830 (UMLS CUI [1,1])
C0337672 (UMLS CUI [1,2])
C0337671 (UMLS CUI [2])
Good health (shown by ECG, safety laboratory tests etc.)
Item
With the exception of asthma, is the subject in good health (as shown by ECG, safety laboratory tests etc.)?
boolean
C1277245 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
Oral corticosteroids, inhaled FP, oral steroids, intranasal/topical FP
Item
Is the subject currently taking any of the following: Oral corticosteroids or inhaled FP, Oral steroids (must have not been used within 4 weeks prior to the Screening Visit and if used during the course of the study should result in subject withdrawal), Intranasal or topical FP (must be excluded within two weeks before Screening Visit and during the study).
boolean
C0001617 (UMLS CUI [1])
C0205535 (UMLS CUI [2,1])
C0082607 (UMLS CUI [2,2])
C0038317 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0304604 (UMLS CUI [4,1])
C0082607 (UMLS CUI [4,2])
Exposition to an investigational drug/placebo
Item
Has the subject been exposed to an investigational drug/placebo within 30 days prior to Visit 1 or within 5 half-lives (t1/2) of the prior investigational product (whichever is the longer of the two)?
boolean
C0205156 (UMLS CUI [1,1])
C0681324 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0205156 (UMLS CUI [2,1])
C0681324 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
Significant diseases (pulmonary disease like cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia; Respiratory tract infection; Pneumonia; disorder of ears, nose, throat, sinuses; Cardiovascular disease; Endocrine disorders; Renal disease; Hepatic disease; Disorder of cellular or humoral immunity; Malignancy)
Item
Is there any historical or current evidence of significant diseases including, but not limited to those listed below: Other significant pulmonary disease including cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia; Respiratory tract infection within 4 weeks prior to screening; Clinical or radiological evidence of pneumonia within the preceding 3 months (Radiographs are not required.); Disorders of the ears, nose, throat or sinuses likely to require surgical intervention during the study treatment period; Cardiovascular disease; Endocrine disorders; Renal disease; Hepatic disease; Disorder of cellular or humoral immunity; Malignancy
boolean
C0750502 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0006287 (UMLS CUI [5])
C0035243 (UMLS CUI [6])
C0032285 (UMLS CUI [7])
C0395797 (UMLS CUI [8])
C0007222 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0022658 (UMLS CUI [11])
C0023895 (UMLS CUI [12])
C1513041 (UMLS CUI [13,1])
C0020967 (UMLS CUI [13,2])
C1513041 (UMLS CUI [14,1])
C0020966 (UMLS CUI [14,2])
C0006826 (UMLS CUI [15])
Hypersensitivity to sympathomimetic drug/intranasal, inhaled or systemic corticosteroid
Item
Does the subject have any immediate or delayed hypersensitivity to any sympathomimetic drug or any intranasal, inhaled or systemic corticosteroid therapy?
boolean
C0020517 (UMLS CUI [1,1])
C0002509 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304604 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C4053960 (UMLS CUI [4,2])
Severe milk protein (lactose) allergy
Item
Does the subject have a history of severe milk protein (lactose) allergy?
boolean
C0022951 (UMLS CUI [1])
C3889086 (UMLS CUI [2])
Drug or alcohol abuse
Item
Does the subject have a history of drug or alcohol abuse?
boolean
C0038586 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Positive urine drug screen including alcohol
Item
Does the subject have a positive urine drug screen (UDS) including alcohol at screening?
boolean
C0743300 (UMLS CUI [1])
C0202304 (UMLS CUI [2])
Positive hepatitis B virus, hepatitis C virus, HIV
Item
Does the subject have a positive hepatitis B virus, hepatitis C virus or HIV test at screening?
boolean
C1446409 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1446409 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Positive serum beta-human chorionic gonadotropin (b-hCG) test
Item
Does the subject have a positive serum beta-human chorionic gonadotropin (b-hCG) test (females)?
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Pregnancy, nursing, childbearing potential, unwilling to use a method of contraception
Item
Is the subject a pregnant or nursing females or a female of childbearing potential who is unwilling or unable to use an appropriate method of contraception from at least 14 days prior to first dose of study medication administration until completion of follow-up procedures?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0558080 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Blood donation
Item
Has the subject donated blood in excess of 500millilitres (mL) within 56 days prior to first dose of study medication?
boolean
C0005794 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Sensitivity to heparin, heparin-induced thrombocytopenia, study medications
Item
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0304229 (UMLS CUI [3,2])
Current smoker
Item
Is the subject a current smokers or has the subject smoked within the last year or have a >5 year pack history?
boolean
C3241966 (UMLS CUI [1])
Prescription or non-prescription drugs (vitamins, herbal,dietary supplements), ritonavir not allowed
Item
Has the subject used prescription or non-prescription drugs (with the exception of permitted asthma medication previously mentioned), including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise study safety? Subjects taking ritonavir should not be included in this study.
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C0936242 (UMLS CUI [6])
C0292818 (UMLS CUI [7,1])
C1298908 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Item
Did the subject meet all entry criteria?
text
C1516637 (UMLS CUI [1])
Code List
Did the subject meet all entry criteria?
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Code List
Inclusion Criteria
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Code List
Exclusion Criteria