ID

38481

Beskrivning

Effect of High Dose Ciclesonide on Asthma Control; ODM derived from: https://clinicaltrials.gov/show/NCT01455194

Länk

https://clinicaltrials.gov/show/NCT01455194

Nyckelord

Versioner (1)
  1. 2019-10-21 2019-10-21 -
Rättsinnehavare

See clinicaltrials.gov

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21 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT01455194

Engelsk

Eligibility Bronchial Asthma NCT01455194

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent was provided
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
history of persistent bronchial asthma for at least 6 months
Beskrivning

Persistent asthma Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0872146
current treatment with an inhaled corticosteroid (ics) at a stable dose in the dose range of 200-1000 μg fluticasone propionate (fp)/day or equivalent for a minimum of 12 weeks
Beskrivning

Adrenal Cortex Hormones by Inhalation Dose Stable | Fluticasone propionate U/day | Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0117996
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
good inhalation technique
Beskrivning

Inhalation technique Good

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1998547
UMLS CUI [1,2]
C0205170
under the current ics pre-treatment the acq score ranges between ≥ 0.75 and ≥ 2
Beskrivning

Adrenal Cortex Hormones by Inhalation Pretreatment | Asthma control questionnaire Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C3539076
UMLS CUI [2,1]
C2919686
UMLS CUI [2,2]
C0449820
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Beskrivning

Laboratory test result abnormal | Suggestive of Disease Unknown | Requirement Clinical Evaluation Additional

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0332299
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0439673
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C4084924
UMLS CUI [3,3]
C1524062
concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis c, acquired immune deficiency syndrome [aids])
Beskrivning

Comorbidity Severe | Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Hepatitis C | AIDS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0442867
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007137
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0001175
diseases which are contraindications for the use of ics (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
Beskrivning

Medical contraindication Adrenal Cortex Hormones by Inhalation | Tuberculosis, Pulmonary | Inactive tuberculosis of lung | Lower respiratory tract infection fungal | Bacterial lower respiratory infection | Viral lower respiratory infection | Requirement Therapeutic procedure Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0205535
UMLS CUI [2]
C0041327
UMLS CUI [3]
C0748179
UMLS CUI [4]
C1691221
UMLS CUI [5]
C0729520
UMLS CUI [6]
C0729532
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0087111
UMLS CUI [7,3]
C0205369
use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Beskrivning

Glucocorticoids, Systemic | Depot Steroids Injectable

Datatyp

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2,1]
C0086129
UMLS CUI [2,2]
C0038317
UMLS CUI [2,3]
C1272883
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Similar models

Eligibility Bronchial Asthma NCT01455194

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent was provided
boolean
C0021430 (UMLS CUI [1])
Persistent asthma Disease length
Item
history of persistent bronchial asthma for at least 6 months
boolean
C3266628 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Adrenal Cortex Hormones by Inhalation Dose Stable | Fluticasone propionate U/day | Equivalent
Item
current treatment with an inhaled corticosteroid (ics) at a stable dose in the dose range of 200-1000 μg fluticasone propionate (fp)/day or equivalent for a minimum of 12 weeks
boolean
C0001617 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0117996 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Inhalation technique Good
Item
good inhalation technique
boolean
C1998547 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Adrenal Cortex Hormones by Inhalation Pretreatment | Asthma control questionnaire Score
Item
under the current ics pre-treatment the acq score ranges between ≥ 0.75 and ≥ 2
boolean
C0001617 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C2919686 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal | Suggestive of Disease Unknown | Requirement Clinical Evaluation Additional
Item
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
boolean
C0438215 (UMLS CUI [1])
C0332299 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C4084924 (UMLS CUI [3,2])
C1524062 (UMLS CUI [3,3])
Comorbidity Severe | Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Hepatitis C | AIDS
Item
concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis c, acquired immune deficiency syndrome [aids])
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442867 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C0019196 (UMLS CUI [5])
C0001175 (UMLS CUI [6])
Medical contraindication Adrenal Cortex Hormones by Inhalation | Tuberculosis, Pulmonary | Inactive tuberculosis of lung | Lower respiratory tract infection fungal | Bacterial lower respiratory infection | Viral lower respiratory infection | Requirement Therapeutic procedure Specific
Item
diseases which are contraindications for the use of ics (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0205535 (UMLS CUI [1,3])
C0041327 (UMLS CUI [2])
C0748179 (UMLS CUI [3])
C1691221 (UMLS CUI [4])
C0729520 (UMLS CUI [5])
C0729532 (UMLS CUI [6])
C1514873 (UMLS CUI [7,1])
C0087111 (UMLS CUI [7,2])
C0205369 (UMLS CUI [7,3])
Glucocorticoids, Systemic | Depot Steroids Injectable
Item
use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
boolean
C3540777 (UMLS CUI [1])
C0086129 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1272883 (UMLS CUI [2,3])
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