Eligibility Asthma NCT02087644

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StudyEvent: Eligibility
1. Eligibility Asthma NCT02087644

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed consent

Item

1. provide written informed consent.

boolean

C0021430 (UMLS CUI [1])

Compliance behavior

Item

2. complete all protocol requirements.

boolean

C1321605 (UMLS CUI [1])

Age

Item

3. between 18 to 65 years of age.

boolean

C0001779 (UMLS CUI [1])

Persistent allergic asthma

Item

4. persistent allergic asthma patients

boolean

C0155877 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])

FEV1

Item

5. forced expiratory volume in one second (fev1) ≥60 percent to ≤ 90 percent of predicted value

boolean

C0748133 (UMLS CUI [1])

Airway Obstruction Reversibility

Item

6. reversibility of airway obstruction

boolean

C0001883 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])

Contraceptive methods

Item

7. patients meeting the contraception requirements

boolean

C0700589 (UMLS CUI [1])

Therapeutic procedure Inhaled steroids | Poorly controlled

Item

8. at baseline: patients treated with ics and insufficiently controlled

boolean

C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C3853134 (UMLS CUI [2])

Eosinophil count procedure

Item

9. blood eosinophil count above a certain level

boolean

C0200638 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Compliance behavior Personal failure Diaries | Compliance behavior Personal failure Peak flow meter (device)

Item

1. failure to meet at least 80 percent compliance of use of the patient e-diary/ peak expiratory flow (pef) meter (am3 device) at the baseline visit

boolean

C1321605 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C0376660 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0680095 (UMLS CUI [2,2])
C0180915 (UMLS CUI [2,3])

Therapeutic procedure Exacerbation of asthma | Hospitalization Exacerbation of asthma

Item

2. treatment or hospitalization for asthma exacerbation within past 2 months

boolean

C0087111 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0349790 (UMLS CUI [2,2])

systemic steroids

Item

3. current use or use of systemic corticosteroids within past 2 months

boolean

C2825233 (UMLS CUI [1])

Current Smoker

Item

4. current smokers.

boolean

C3241966 (UMLS CUI [1])

Former smoker Smoking cigarettes: ____ pack-years history

Item

5. ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years

boolean

C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])

major surgery | Informed Consent

Item

6. major surgery within 3 months prior to signing the icf or anticipated during study

boolean

C0679637 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

Item

7. presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. copd), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.

boolean

C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0037274 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0015397 (UMLS CUI [10])

Malignant Neoplasms

Item

8. any malignancy within the previous 5 years

boolean

C0006826 (UMLS CUI [1])

Lymphadenopathy | Splenomegaly | Physical Examination

Item

9. presence of suspicious lymphadenopathy or splenomegaly on physical examination.

boolean

C0497156 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
C0031809 (UMLS CUI [3])

Communicable Diseases HIV | Communicable Diseases Hepatitis B Virus | Communicable Diseases Hepatitis C virus

Item

10. confirmed or suspected current infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv).

boolean

C0009450 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])

Communicable Diseases

Item

11. presence of active infectious disease as judged by the investigator

boolean

C0009450 (UMLS CUI [1])

Autoimmune Diseases | Rheumatoid Arthritis | lupus erythematodes | Ulcerative Colitis

Item

12. active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.

boolean

C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0866588 (UMLS CUI [3])
C0009324 (UMLS CUI [4])

Pregnancy Urine pregnancy test positive | Breast Feeding

Item

13. pregnancy (based on positive urine test at screening visit) or lactation.

boolean

C0032961 (UMLS CUI [1,1])
C0430059 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])

Pregnancy, Planned

Item

14. female planning to become pregnant during the study period.

boolean

C0032992 (UMLS CUI [1])

Substance Use Disorders

Item

15. patients with any history of abuse of alcohol or other recreational drugs.

boolean

C0038586 (UMLS CUI [1])

Immunotherapy, specific

Item

16. ongoing or planned specific immunotherapy (sit) during the whole study period or sit completed within the last 3 years.

boolean

C0021083 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])

Body mass index

Item

17. bmi >40

boolean

C1305855 (UMLS CUI [1])

Biological Factors | Biological Response Modifiers

Item

18. use of investigational or approved biologics/immune-modulators within the last 6 months.

boolean

C0005515 (UMLS CUI [1])
C0005525 (UMLS CUI [2])

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Eligibility Asthma NCT02087644