Eligibility Asthma NCT01907763

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StudyEvent: Eligibility
1. Eligibility Asthma NCT01907763

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Gender

Item

1. male or eligible female subjects aged 15 years or more

boolean

C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])

Female | eligible

Item

2. a female is eligible if she is of:

boolean

Incapable | Pregnancy | Postmenopausal state

Item

non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal

boolean

C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])

Childbearing Potential | Contraceptive methods

Item

child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly

boolean

C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])

Pregnancy test negative

Item

negative pregnancy test at screening

boolean

C0427780 (UMLS CUI [1])

Non-smoker | pack-years history

Item

3. non-smoker for at least 1 year, a pack history of ≤ 10 pack years

boolean

C0337672 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])

Persistent asthma | FEV1

Item

4. symptom of persistent asthma, as defined by the national institute of health (nih) 5.50 percent ≤ fev1 ≤ 80 percent predicted at screening visit (withholding inhaled, short acting

boolean

C3266628 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])

Adrenergic beta-Agonists

Item

ß-agonist for 6 hours)

boolean

C0001644 (UMLS CUI [1])

FEV1 | Reversibility

Item

6.fev1 reversibility ≥ 12 percent and 200 ml at 20-30 minutes after inhalation of a short acting

boolean

C0748133 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])

Adrenergic beta-Agonists | Salbutamol

Item

ß-agonist (salbutamol 2 puffs; 200㎍) at visit 1 or within 6 months before visit 1 7.capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.appropriately signed and dated informed consent has been obtained

boolean

C0001644 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Upper Respiratory Infections | Lower respiratory tract infection

Item

1. active upper or lower respiratory tract infection within 3 weeks before visit 1

boolean

C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])

Hospitalized or emergency room | Therapeutic procedure | Asthma

Item

2. emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1

boolean

C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3475492 (UMLS CUI [1,3])

Infectious Diseases | oncologic disorders | Lung diseases | Plain chest X-ray

Item

3. any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1

boolean

C0009450 (UMLS CUI [1])
C3853943 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])

Hematological Disease | Liver diseases | Kidney Diseases | Heart Diseases | nervous system disorder

Item

4. clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease

boolean

C0018939 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C2359476 (UMLS CUI [6])

Hypersensitivity | Adrenergic beta-2 Receptor Agonists | Sympathomimetics | Leukotriene Antagonists

Item

5. hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or sophora tonkinensis radix rhizoma

boolean

C0020517 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039052 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0595726 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C2816591 (UMLS CUI [3,2])
C0020517 (UMLS CUI [3,3])
C0242726 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0949790 (UMLS CUI [4,2])

Mental disorders | Uncontrolled

Item

6. clinically significant and uncontrolled psychiatric disease

boolean

C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])

Drug or alcohol abuse

Item

7. history of drug or alcohol abuse

boolean

C0237123 (UMLS CUI [1])

Inhaled steroids | Oral steroids | Parenteral steroids

Item

8. inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1

boolean

C2065041 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C1272936 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])

Immunotherapy | Changing

Item

9. change of immunotherapy within 6 months before visit 1

boolean

C0021083 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])

Anti-Asthmatic Agents

Item

10. administration of the antiasthma agent within 1 week of visit 1

boolean

C0282556 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])

Pharmaceutical Preparations | Affecting | Asthma | Amines, Sympathomimetic

Item

11. administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines

boolean

C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0002509 (UMLS CUI [2])

Study Subject Participation Status | Use of | Experimental drug

Item

12. participation in study using an experimental medication within 1 month before visit 1

boolean

C2348568 (UMLS CUI [1])

patient not eligible

Item

13. other ineligible subject in the opinion of the investigator

boolean

C3242266 (UMLS CUI [1])

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Eligibility Asthma NCT01907763