Eligibility Asthma NCT02075255

1 Formulários

StudyEvent: Eligibility
1. Eligibility Asthma NCT02075255

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed consent

Item

1. provision of informed consent prior to any study specific procedures

boolean

C0021430 (UMLS CUI [1])

Age | Gender

Item

2. female and male aged from 18 to 75 years, inclusively

boolean

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

Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Item

3. history of physician-diagnosed asthma requiring treatment with medium dose ics and a laba

boolean

C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])

Eosinophilia | peripheral blood

Item

4. elevated level of peripheral blood eosinophil

boolean

C0014457 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])

Therapeutic procedure | inhaled steroids | High dose | Adrenergic beta-2 Receptor Agonists

Item

5. documented treatment with high-dose ics and laba for at least 6 months prior to visit 1

boolean

C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
C2936789 (UMLS CUI [2])

Therapeutic procedure | Prednisone Oral Product | prednisolone Oral Product

Item

6. chronic oral prednisone or prednisolone therapy for at least 6 continuous months directly preceding visit 1, and on a stable dose for at least one month prior to visit 1

boolean

C0087111 (UMLS CUI [1,1])
C3216040 (UMLS CUI [1,2])
C0358513 (UMLS CUI [2])

Adrenal Cortex Hormones | Reduced | failed

Item

7. patients with documented failures of ocs reduction within 6 months prior to visit 1 will not be required to proceed through the dose optimization phase during run-in.

boolean

C0001617 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])

FEV1 | pre bronchodilator | Morning

Item

8. morning pre-bronchodilator (pre-bd) fev1 of <80 percent predicted

boolean

C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])

FEV1 | post bronchodilator | Reversibility

Item

9. either documented post bronchodilator (post-bd) reversibility of ≥ 12% and ≥ 200 ml in fev1 or pc20 fev1

boolean

C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C0449261 (UMLS CUI [1,3])

Exacerbation of asthma | Informed Consent

Item

10. at least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained

boolean

C0349790 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

Adrenal Cortex Hormones

Item

11. optimized ocs dose reached at least 2 weeks prior to randomization

boolean

C0001617 (UMLS CUI [1])

Asthma | Pharmaceutical Preparations | Additional

Item

12. additional asthma controller medication must not have been initiated during run-in period

boolean

C0004096 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])

Compliance behavior | Adrenal Cortex Hormones

Item

13. at least 70 percent compliance with ocs use

boolean

C1321605 (UMLS CUI [1])
C0001617 (UMLS CUI [2])

Compliance behavior | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Item

14. at least 70 percent compliance with usual asthma controller ics-laba

boolean

C1321605 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])

Compliance behavior | Asthma | Diaries

Item

15. minimum 70 percent (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary)

boolean

C1321605 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0376660 (UMLS CUI [2,2])

Exacerbation of asthma

Item

16. no documented asthma exacerbations during the screening/dose optimization period

boolean

C0349790 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Lung diseases | Systemic disease | Eosinophilia

Item

1. clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.

boolean

C0024115 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C0014457 (UMLS CUI [3])

Item

2. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

boolean

C0007222 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0026857 (UMLS CUI [6])
C0009450 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0231171 (UMLS CUI [12])

Disease | Affecting | patient safety

Item

affect the safety of the patient throughout the study

boolean

C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])

Disease | Affecting | research results

Item

influence the findings of the studies or their interpretations

boolean

C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])

Disease | Study Subject Participation Status | Limited

Item

impede the patient's ability to complete the entire duration of study

boolean

C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])

Upper Respiratory Infections | Lower respiratory tract infection | Antibiotics | Antiviral Agents | Informed Consent

Item

3. acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period

boolean

C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
C0003451 (UMLS CUI [4])
C0021430 (UMLS CUI [5])

Item

4. any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

boolean

C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
C0474523 (UMLS CUI [3])
C0008000 (UMLS CUI [4])
C0042014 (UMLS CUI [5])
C2348568 (UMLS CUI [6])

Asthma | Life Threatening

Item

5. history of life-threatening asthma

boolean

C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])

Asthma | control substance | Adrenal Cortex Hormones

Item

6. asthma control reached at an ocs dose of ≤5mg during run-in/ocs optimization phase

boolean

C0004096 (UMLS CUI [1])
C1550141 (UMLS CUI [2])
C0001617 (UMLS CUI [3])

Drug dose | Reduced | Adrenal Cortex Hormones

Item

7. qualifies for 3 consecutive dose reductions at visits 2-4 and continues to meet ocs dose reduction criteria at visit 5

boolean

C0678766 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])

Asthma | Symptoms | Oral form dexamethasone | Adrenal Cortex Hormones

Item

8. receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms

boolean

C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0360528 (UMLS CUI [2])
C0001617 (UMLS CUI [3])

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Eligibility Asthma NCT02075255