Gender | Caucasoid | Informed Consent
Item
1. male or female patients of caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
boolean
C0079399 (UMLS CUI [1,1])
C0007457 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Asthma | Informed Consent
Item
2. physician based (according to gina 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the csp
boolean
C0004096 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Prebronchodilator | Morning | Abstinence
Item
3. morning prebronchodilator (ie, after abstinence from short-acting and long-acting
boolean
C2599602 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C3843422 (UMLS CUI [1,3])
Beta-agonist | FEV1 | Age | Gender | Body Height
Item
ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) fev1 of ≥70 percent of predicted normal (pn) for age, sex and height at enrolment
boolean
C0001644 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0079399 (UMLS CUI [1,4])
C0005890 (UMLS CUI [1,5])
Neutrophil count | Sputum, Induced | Sputum Total
Item
4. increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50 percent of total sputum cell count
boolean
C0948762 (UMLS CUI [1,1])
C3179346 (UMLS CUI [1,2])
C0200633 (UMLS CUI [1,3])
C0038056 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0007584 (UMLS CUI [1,6])
Inhaled steroids used daily | fluticasone
Item
5. physician prescribed daily use of medium or high dose ics (≥ fluticasone 250 μg to ≤
boolean
C4040610 (UMLS CUI [1,1])
C0082607 (UMLS CUI [1,2])
Fluticasone | Adrenergic beta-2 Receptor Agonists
Item
1.000 µg or the equivalent daily, as defined in gina 2011; see csp appendix e) plus laba.
boolean
C0082607 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
Hypersensitivity | AZD5069 | CXCR2 gene antagonists | Salbutamol allergy | Local Anesthetics
Item
1. history of clinically relevant allergies or idiosyncrasies to azd5069 or other investigational cxcr2 antagonists, or any inactive ingredient(s) of the imp, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study
boolean
C0020517 (UMLS CUI [1,1])
C4045791 (UMLS CUI [1,2])
C1334126 (UMLS CUI [2,1])
C0243076 (UMLS CUI [2,2])
C0570955 (UMLS CUI [3])
C0002934 (UMLS CUI [4])
Exacerbation of severe persistent asthma | Hospitalization Required
Item
2. history of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
boolean
C3508930 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Exacerbation of asthma | Treatment required | systemic steroids
Item
3. asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
boolean
C0349790 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0001617 (UMLS CUI [1,4])
C1272936 (UMLS CUI [2])
FEV1 | Abnormal airflow
Item
4. moderate to severe airflow limitation (fev1 <70% pn)
boolean
C0748133 (UMLS CUI [1,1])
C0232000 (UMLS CUI [1,2])
C1881878 (UMLS CUI [1,3])
C0205082 (UMLS CUI [2])
Chronic lower respiratory disease
Item
5. any chronic lower respiratory disease other than asthma (see csp for details) that, as judged by the investigator or medical monitor, would interfere with the evaluation of the imp or interpretation of patient safety or study results.
boolean
C0348692 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009488 (UMLS CUI [1,5])