pre bronchodilator FEV1
Item
1. pre-bronchodilator clinic measured fev1 of =40% and =85% of predicted normal.
boolean
C2599602 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Asthma | Forced Expiratory Volume in 1 Second Reversibility | Albuterol
Item
2. one year history of asthma diagnosed by a physician, and have fev1 reversibility of = 12% and an absolute change of at least 200 ml after administration of 400 µg salbutamol.
boolean
C0004096 (UMLS CUI [1])
C3830088 (UMLS CUI [2])
C0001927 (UMLS CUI [3])
inhaled steroids | Asthma control Pharmaceutical Preparations
Item
3. must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
boolean
C2065041 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Exacerbation of severe persistent asthma
Item
4. must have documented history of two or more severe asthma exacerbations in the last 12 months.
boolean
C3508930 (UMLS CUI [1])
Disease | Asthma
Item
1. patients with a significant disease other than asthma.
boolean
C0012634 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Ability Sputum production Quality | Ability Sputum specimen Quality
Item
2. patients who are not able to produce sputum or sputum samples of sufficient quality.
boolean
C0085732 (UMLS CUI [1,1])
C0242104 (UMLS CUI [1,2])
C0332306 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C0444159 (UMLS CUI [2,2])
C0332306 (UMLS CUI [2,3])
Exacerbation of asthma Intubation
Item
3. patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
boolean
C0349790 (UMLS CUI [1,1])
C0021925 (UMLS CUI [1,2])
Respiration Disorders Concurrent
Item
4. patients diagnosed with any concurrent respiratory disease.
boolean
C0035204 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Myocardial Infarction | Hospitalization Heart failure
Item
5. recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
boolean
C0027051 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Thoracotomy Lung excision
Item
6. patients who have undergone thoracotomy with pulmonary resection.
boolean
C0039991 (UMLS CUI [1,1])
C0396565 (UMLS CUI [1,2])
Bronchial thermoplasty | Therapeutic radiology procedure | Planned procedure
Item
7. patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
boolean
C3854686 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1320712 (UMLS CUI [3])
Adrenal Cortex Hormones | Prednisone
Item
8. patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
9. pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Sexually active | Unwilling Contraceptive methods
Item
10. women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
boolean
C3831118 (UMLS CUI [1])
C0241028 (UMLS CUI [2])
C0558080 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Acute infectious disease | Chronic infectious disease
Item
11. clinically relevant acute infections or chronic infections.
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Attenuated Bacteria Vaccine | Attenuated Live Virus Vaccine
Item
12. have received any live bacterial or live viral vaccination in the last12 weeks.
boolean
C1879753 (UMLS CUI [1])
C1516086 (UMLS CUI [2])
BCG Vaccine
Item
13. have received bacille calmette-guerin (bcg) vaccination in the last 12 months.
boolean
C0004886 (UMLS CUI [1])
Therapeutic procedure Ustekinumab Stelara
Item
14. have received treatment with ustekinumab (stelara®).
boolean
C0087111 (UMLS CUI [1,1])
C1608841 (UMLS CUI [1,2])
C2702169 (UMLS CUI [1,3])
Other Biological Products
Item
15. have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
boolean
C0205394 (UMLS CUI [1,1])
C0005522 (UMLS CUI [1,2])