Eligibility Asthma NCT01928771

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StudyEvent: Eligibility
1. Eligibility Asthma NCT01928771

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed consent

Item

1. written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable european union guidelines.

boolean

C0021430 (UMLS CUI [1])

Age | Gender

Item

2. female and male aged 12 to 75 years inclusively, at the time of visit 1. for those patients, who are 17 on the day of visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.

boolean

C0001779 (UMLS CUI [1,1])
C0205653 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])

Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Item

3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (>250μg fluticasone dry powder formulation equivalents total daily dose) and a laba, for at least 12 months prior to visit 1

boolean

C0004096 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0082607 (UMLS CUI [3])
C2936789 (UMLS CUI [4])

Therapeutic procedure | inhaled steroids | Adrenergic beta-2 Receptor Agonists | Oral steroids

Item

4. documented treatment with ics and laba for at least 3 months prior to visit 1 with or without oral corticosteroids and additional asthma controllers.

boolean

C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
C0001617 (UMLS CUI [3])

Age | inhaled steroids | Fluticasone propionate

Item

for subjects 18 years of age and older, the ics dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.

boolean

C0001779 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])

Age | inhaled steroids | Fluticasone propionate

Item

for subjects ages 12-17, the ics dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

boolean

C0001779 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Pulmonary disease | Systemic disease

Item

1. clinically important pulmonary disease other than asthma (e.g. active lung infection, copd, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, churg- strauss syndrome, hypereosinophilic syndrome)

boolean

C0024115 (UMLS CUI [1])
C0876973 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0010674 (UMLS CUI [6])
C0745186 (UMLS CUI [7])
C0028754 (UMLS CUI [8])
C0242379 (UMLS CUI [9])
C0221757 (UMLS CUI [10])
C0008780 (UMLS CUI [11])
C0442893 (UMLS CUI [12])
C2350530 (UMLS CUI [13])
C2931854 (UMLS CUI [14])
C0008728 (UMLS CUI [15])
C1540912 (UMLS CUI [16])

Disease | Stable status

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

C0012634 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0026857 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
C0004936 (UMLS CUI [12])
C0231171 (UMLS CUI [13])

Comorbidity | patient safety

Item

affect the safety of the patient throughout the study

boolean

C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])

Compliance behavior | Limited | Comorbidity

Item

influence the findings of the studies or their interpretations

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

Comorbidity | Study Subject Participation Status

Item

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

boolean

C0009488 (UMLS CUI [1])
C2348568 (UMLS CUI [2])

Upper Respiratory Infections | Lower respiratory tract infection

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])

Abnormal Finding | Study Subject Participation Status

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

C2826279 (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])

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Eligibility Asthma NCT01928771