ID

42141

Description

Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01907763

Link

https://clinicaltrials.gov/show/NCT01907763

Keywords

Versions (4)
  1. 3/30/16 3/30/16 -
  2. 3/30/16 3/30/16 - Julian Varghese
  3. 3/30/16 3/30/16 - Julian Varghese
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT01907763

English

Eligibility Asthma NCT01907763

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01907763
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or eligible female subjects aged 15 years or more
Description

Age | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
2. a female is eligible if she is of:
Description

Female | eligible

Data type

boolean

non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
Description

Incapable | Pregnancy | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232970
child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
Description

Childbearing Potential | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0680240
negative pregnancy test at screening
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
3. non-smoker for at least 1 year, a pack history of ≤ 10 pack years
Description

Non-smoker | pack-years history

Data type

boolean

Alias
UMLS CUI [1,1]
C0337672
UMLS CUI [1,2]
C2230126
4. symptom of persistent asthma, as defined by the national institute of health (nih) 5.50 percent ≤ fev1 ≤ 80 percent predicted at screening visit (withholding inhaled, short acting
Description

Persistent asthma | FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0748133
ß-agonist for 6 hours)
Description

Adrenergic beta-Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0001644
6.fev1 reversibility ≥ 12 percent and 200 ml at 20-30 minutes after inhalation of a short acting
Description

FEV1 | Reversibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0449261
ß-agonist (salbutamol 2 puffs; 200㎍) at visit 1 or within 6 months before visit 1 7.capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.appropriately signed and dated informed consent has been obtained
Description

Adrenergic beta-Agonists | Salbutamol

Data type

boolean

Alias
UMLS CUI [1,1]
C0001644
UMLS CUI [1,2]
C0001927
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active upper or lower respiratory tract infection within 3 weeks before visit 1
Description

Upper Respiratory Infections | Lower respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
2. emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
Description

Hospitalized or emergency room | Therapeutic procedure | Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C3475492
3. any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
Description

Infectious Diseases | oncologic disorders | Lung diseases | Plain chest X-ray

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C3853943
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0039985
4. clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
Description

Hematological Disease | Liver diseases | Kidney Diseases | Heart Diseases | nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0027765
UMLS CUI [6]
C2359476
5. hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or sophora tonkinensis radix rhizoma
Description

Hypersensitivity | Adrenergic beta-2 Receptor Agonists | Sympathomimetics | Leukotriene Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2936789
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039052
UMLS CUI [2,3]
C0020517
UMLS CUI [2,4]
C0595726
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2816591
UMLS CUI [3,3]
C0020517
UMLS CUI [3,4]
C0242726
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0949790
6. clinically significant and uncontrolled psychiatric disease
Description

Mental disorders | Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
7. history of drug or alcohol abuse
Description

Drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0237123
8. inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
Description

Inhaled steroids | Oral steroids | Parenteral steroids

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C1272936
UMLS CUI [3,2]
C0001617
9. change of immunotherapy within 6 months before visit 1
Description

Immunotherapy | Changing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0392747
10. administration of the antiasthma agent within 1 week of visit 1
Description

Anti-Asthmatic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0282556
UMLS CUI [1,2]
C1533734
11. administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
Description

Pharmaceutical Preparations | Affecting | Asthma | Amines, Sympathomimetic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0004096
UMLS CUI [2]
C0002509
12. participation in study using an experimental medication within 1 month before visit 1
Description

Study Subject Participation Status | Use of | Experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C2348568
13. other ineligible subject in the opinion of the investigator
Description

patient not eligible

Data type

boolean

Alias
UMLS CUI [1]
C3242266
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Similar models

Eligibility Asthma NCT01907763

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01907763
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
1. male or eligible female subjects aged 15 years or more
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Female | eligible
Item
2. a female is eligible if she is of:
boolean
Incapable | Pregnancy | Postmenopausal state
Item
non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
boolean
C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Childbearing Potential | Contraceptive methods
Item
child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Pregnancy test negative
Item
negative pregnancy test at screening
boolean
C0427780 (UMLS CUI [1])
Non-smoker | pack-years history
Item
3. non-smoker for at least 1 year, a pack history of ≤ 10 pack years
boolean
C0337672 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
Persistent asthma | FEV1
Item
4. symptom of persistent asthma, as defined by the national institute of health (nih) 5.50 percent ≤ fev1 ≤ 80 percent predicted at screening visit (withholding inhaled, short acting
boolean
C3266628 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Adrenergic beta-Agonists
Item
ß-agonist for 6 hours)
boolean
C0001644 (UMLS CUI [1])
FEV1 | Reversibility
Item
6.fev1 reversibility ≥ 12 percent and 200 ml at 20-30 minutes after inhalation of a short acting
boolean
C0748133 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
Adrenergic beta-Agonists | Salbutamol
Item
ß-agonist (salbutamol 2 puffs; 200㎍) at visit 1 or within 6 months before visit 1 7.capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.appropriately signed and dated informed consent has been obtained
boolean
C0001644 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Upper Respiratory Infections | Lower respiratory tract infection
Item
1. active upper or lower respiratory tract infection within 3 weeks before visit 1
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Hospitalized or emergency room | Therapeutic procedure | Asthma
Item
2. emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3475492 (UMLS CUI [1,3])
Infectious Diseases | oncologic disorders | Lung diseases | Plain chest X-ray
Item
3. any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
boolean
C0009450 (UMLS CUI [1])
C3853943 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
Hematological Disease | Liver diseases | Kidney Diseases | Heart Diseases | nervous system disorder
Item
4. clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
boolean
C0018939 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C2359476 (UMLS CUI [6])
Hypersensitivity | Adrenergic beta-2 Receptor Agonists | Sympathomimetics | Leukotriene Antagonists
Item
5. hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or sophora tonkinensis radix rhizoma
boolean
C0020517 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039052 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0595726 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C2816591 (UMLS CUI [3,2])
C0020517 (UMLS CUI [3,3])
C0242726 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0949790 (UMLS CUI [4,2])
Mental disorders | Uncontrolled
Item
6. clinically significant and uncontrolled psychiatric disease
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Drug or alcohol abuse
Item
7. history of drug or alcohol abuse
boolean
C0237123 (UMLS CUI [1])
Inhaled steroids | Oral steroids | Parenteral steroids
Item
8. inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
boolean
C2065041 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C1272936 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
Immunotherapy | Changing
Item
9. change of immunotherapy within 6 months before visit 1
boolean
C0021083 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Anti-Asthmatic Agents
Item
10. administration of the antiasthma agent within 1 week of visit 1
boolean
C0282556 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Pharmaceutical Preparations | Affecting | Asthma | Amines, Sympathomimetic
Item
11. administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0002509 (UMLS CUI [2])
Study Subject Participation Status | Use of | Experimental drug
Item
12. participation in study using an experimental medication within 1 month before visit 1
boolean
C2348568 (UMLS CUI [1])
patient not eligible
Item
13. other ineligible subject in the opinion of the investigator
boolean
C3242266 (UMLS CUI [1])
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