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])
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])