ID

38472

Description

A Study to Assess Safety and Efficacy of a Novel Treatment, Keratinocyte Growth Factor (KGF), in Asthmatic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01386151

Link

https://clinicaltrials.gov/show/NCT01386151

Keywords

Versions (1)
  1. 10/21/19 10/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 21, 2019

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License

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT01386151

English

Eligibility Bronchial Asthma NCT01386151

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 - 60 years, either gender
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of asthma for > 1 year as defined by bts guidelines, requiring treatment with high dose inhaled corticosteroids +/- long acting β2 agonists, with persisting symptoms requiring use of short-acting beta agonist therapy >3x/week.
Description

Asthma Disease length | Requirement Adrenal Cortex Hormones by Inhalation High dose | Adrenergic beta-2 Receptor Agonists Active Long-term | Adrenergic beta-2 Receptor Agonists Absent | Symptoms Persistent | Requirement Adrenergic beta-Agonists Active short-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0205535
UMLS CUI [2,4]
C0444956
UMLS CUI [3,1]
C2936789
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
UMLS CUI [4,1]
C2936789
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0205322
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0001644
UMLS CUI [6,3]
C0205177
UMLS CUI [6,4]
C0443303
never-smoker or ex-smoker, having stopped >1 year ago, with <10 pack year history.
Description

Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C2230126
subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
subject considered fit enough to undergo lung function testing including provocation tests, and bronchoscopy.
Description

Study Subject Fit Pulmonary function tests | Pulmonary function challenge test | Bronchoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0424576
UMLS CUI [1,3]
C0024119
UMLS CUI [2]
C1096110
UMLS CUI [3]
C0006290
subject must not be participating in another clinical trial or have done so within the last 12 weeks.
Description

Study Subject Participation Status | Absence Participation Clinical Trial Other

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205394
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients requiring regular maintenance oral steroids for their asthma, or those who are adhering to symbicort smart single inhaler regime.
Description

Oral steroid-dependent asthma | Symbicort Inhalant Product Regimen

Data type

boolean

Alias
UMLS CUI [1]
C4510155
UMLS CUI [2,1]
C3239267
UMLS CUI [2,2]
C0040808
pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test >5miu/ml), an intention to become pregnant or breast-feeding (lactating).
Description

Pregnancy | HCG pregnancy test Positive | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0546577
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0006147
subjects with active lung disease other than asthma
Description

Lung disease | Exception Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004096
significant medical (cardiopulmonary, neurological, renal, endocrine, gastrointestinal, psychiatric, hepatic or haematological)co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial, or which is uncontrolled with standard treatment.
Description

Comorbidity Impact Interpretation Research results | Comorbidity Impact Study Subject Participation Status | Comorbidity Uncontrolled | Cor pulmonale | Nervous system disorder | Kidney Disease | Endocrine System Disease | Gastrointestinal Disease | Mental disorder | Liver disease | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0034072
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0023895
UMLS CUI [11]
C0018939
current participation in another clinical trial or previous participation within the last 12 weeks.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
alcohol or active drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
ongoing allergen desensitisation therapy
Description

Allergen Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0162352
regular use of sedatives, hypnotics, tranquilisers
Description

Use of Sedatives Regular | Use of Hypnotics Regular | Use of Tranquilizing Agents Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0036557
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0020591
UMLS CUI [2,3]
C0205272
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0040614
UMLS CUI [3,3]
C0205272
cancer or previous history of cancer
Description

Malignant Neoplasms | Individual Cancer History

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1512706
inability to understand directions for dosing and study assessment.
Description

Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
inability to be contacted in case of emergency.
Description

Patient unavailable Emergency Situation

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C0013956
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Similar models

Eligibility Bronchial Asthma NCT01386151

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 - 60 years, either gender
boolean
C0001779 (UMLS CUI [1])
Asthma Disease length | Requirement Adrenal Cortex Hormones by Inhalation High dose | Adrenergic beta-2 Receptor Agonists Active Long-term | Adrenergic beta-2 Receptor Agonists Absent | Symptoms Persistent | Requirement Adrenergic beta-Agonists Active short-term
Item
confirmed diagnosis of asthma for > 1 year as defined by bts guidelines, requiring treatment with high dose inhaled corticosteroids +/- long acting β2 agonists, with persisting symptoms requiring use of short-acting beta agonist therapy >3x/week.
boolean
C0004096 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
C0444956 (UMLS CUI [2,4])
C2936789 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C2936789 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0205322 (UMLS CUI [5,2])
C1514873 (UMLS CUI [6,1])
C0001644 (UMLS CUI [6,2])
C0205177 (UMLS CUI [6,3])
C0443303 (UMLS CUI [6,4])
Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
never-smoker or ex-smoker, having stopped >1 year ago, with <10 pack year history.
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Comprehension Study Protocol | Informed Consent
Item
subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Study Subject Fit Pulmonary function tests | Pulmonary function challenge test | Bronchoscopy
Item
subject considered fit enough to undergo lung function testing including provocation tests, and bronchoscopy.
boolean
C0681850 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
C1096110 (UMLS CUI [2])
C0006290 (UMLS CUI [3])
Study Subject Participation Status | Absence Participation Clinical Trial Other
Item
subject must not be participating in another clinical trial or have done so within the last 12 weeks.
boolean
C2348568 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Oral steroid-dependent asthma | Symbicort Inhalant Product Regimen
Item
patients requiring regular maintenance oral steroids for their asthma, or those who are adhering to symbicort smart single inhaler regime.
boolean
C4510155 (UMLS CUI [1])
C3239267 (UMLS CUI [2,1])
C0040808 (UMLS CUI [2,2])
Pregnancy | HCG pregnancy test Positive | Pregnancy, Planned | Breast Feeding
Item
pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test >5miu/ml), an intention to become pregnant or breast-feeding (lactating).
boolean
C0032961 (UMLS CUI [1])
C0546577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Lung disease | Exception Asthma
Item
subjects with active lung disease other than asthma
boolean
C0024115 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Comorbidity Impact Interpretation Research results | Comorbidity Impact Study Subject Participation Status | Comorbidity Uncontrolled | Cor pulmonale | Nervous system disorder | Kidney Disease | Endocrine System Disease | Gastrointestinal Disease | Mental disorder | Liver disease | Hematological Disease
Item
significant medical (cardiopulmonary, neurological, renal, endocrine, gastrointestinal, psychiatric, hepatic or haematological)co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial, or which is uncontrolled with standard treatment.
boolean
C0009488 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0034072 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0023895 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
Study Subject Participation Status
Item
current participation in another clinical trial or previous participation within the last 12 weeks.
boolean
C2348568 (UMLS CUI [1])
Substance Use Disorders
Item
alcohol or active drug abuse.
boolean
C0038586 (UMLS CUI [1])
Allergen Immunotherapy
Item
ongoing allergen desensitisation therapy
boolean
C0162352 (UMLS CUI [1])
Use of Sedatives Regular | Use of Hypnotics Regular | Use of Tranquilizing Agents Regular
Item
regular use of sedatives, hypnotics, tranquilisers
boolean
C1524063 (UMLS CUI [1,1])
C0036557 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0020591 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0040614 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
Malignant Neoplasms | Individual Cancer History
Item
cancer or previous history of cancer
boolean
C0006826 (UMLS CUI [1])
C1512706 (UMLS CUI [2])
Study Protocol Comprehension Unable
Item
inability to understand directions for dosing and study assessment.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Patient unavailable Emergency Situation
Item
inability to be contacted in case of emergency.
boolean
C1301818 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
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