ID

35906

Description

Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02243189

Link

https://clinicaltrials.gov/show/NCT02243189

Keywords

Versions (1)
  1. 4/2/19 4/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Healthy NCT02243189

English

Eligibility Healthy NCT02243189

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT02243189
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a. healthy participants and atopic mild to mild-persistent asthmatic participants:
Description

Healthy Volunteers | Mild asthma Atopic | Mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0581124
UMLS CUI [2,2]
C0392707
UMLS CUI [3]
C1960046
participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the weekend as part of social gathering) for at least 3 months prior to screening, according to the participant's self-reported medical history. participants should be willing to (continue to) abstain from smoking from screening until completion of the last study related activity
Description

Non-smoker | Tobacco use Irregular | Refrain from Smoking Willing

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0205271
UMLS CUI [3,1]
C4086797
UMLS CUI [3,2]
C0600109
participants must have a body mass index (bmi: weight in kilogram [kg] divided by the height in square meter [m^2]) of 18.0 to 30.0 kg/m^2, extremes included
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
participants must have a normal 12-lead electrocardiogram (ecg) at screening including normal sinus rhythm (heart rate between 40 and 100 beats per minute [bpm]); qt interval corrected for heart rate according to fridericia (qtcf) interval less than and equal to (<=) 450 milliseconds (ms); qrs interval lower than 120 ms; and pr interval <=220 ms
Description

12 lead ECG Normal | Normal sinus rhythm | Heart rate | QTcF - Fridericia's Correction Formula | QRS interval | PR interval duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0232202
UMLS CUI [3]
C0018810
UMLS CUI [4]
C1882513
UMLS CUI [5]
C0520880
UMLS CUI [6]
C0429024
participants must be healthy, with the exception of findings related to asthma and allergy in atopic mild to mild-persistent asthmatic participants, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs (systolic blood pressure [bp], diastolic bp, pulse rate, respiratory rate, and body temperature), and the results of blood biochemistry and hematology tests performed at screening
Description

Healthy Volunteers | Exception Asthma | Exception Hypersensitivity | Exception Mild asthma Atopic | Exception Mild persistent asthma | Abnormality Clinical Absent | Evaluation procedure | Physical Examination | Medical History | Vital signs | Systolic Pressure | Diastolic blood pressure | Pulse Rate | Respiratory rate | Body Temperature | Normal blood biochemistry | Hematologic Tests

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020517
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0581124
UMLS CUI [4,3]
C0392707
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1960046
UMLS CUI [6,1]
C1704258
UMLS CUI [6,2]
C0205210
UMLS CUI [6,3]
C0332197
UMLS CUI [7]
C1261322
UMLS CUI [8]
C0031809
UMLS CUI [9]
C0262926
UMLS CUI [10]
C0518766
UMLS CUI [11]
C0871470
UMLS CUI [12]
C0428883
UMLS CUI [13]
C0232117
UMLS CUI [14]
C0231832
UMLS CUI [15]
C0005903
UMLS CUI [16]
C4229061
UMLS CUI [17]
C0018941
participants must be willing/ able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
b. atopic mild to mild-persistent asthmatic participants:
Description

Mild asthma Atopic | Mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0581124
UMLS CUI [1,2]
C0392707
UMLS CUI [2]
C1960046
participants with investigator-diagnosed mild to mild-persistent asthma based on the guidelines for the diagnosis and management of asthma
Description

Mild asthma | Mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581124
UMLS CUI [2]
C1960046
participants having a well-established allergen profile (participants have been previously skin tested and, by history, have allergic responses to specific allergens)
Description

Allergen Profile Established | Skin tests | Allergic Reaction Allergens Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0002092
UMLS CUI [1,2]
C1979963
UMLS CUI [1,3]
C0443211
UMLS CUI [2]
C0037296
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0002092
UMLS CUI [3,3]
C0205369
participants with forced expiratory volume in 1 second (fev1) greater than (>) 70 percent (%) of predicted at baseline
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0849974
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a. healthy participants and atopic mild to mild-persistent asthmatic participants:
Description

Healthy Volunteers | Mild asthma Atopic | Mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0581124
UMLS CUI [2,2]
C0392707
UMLS CUI [3]
C1960046
participants having a significant (by the assessment of the investigator) nasal abnormality and/or has a history of nasal or sinus surgery within 12 months of enrollment
Description

Nasal abnormality | Operation on nose | Sinus operation

Data type

boolean

Alias
UMLS CUI [1]
C0265736
UMLS CUI [2]
C0188970
UMLS CUI [3]
C0748725
participants having an upper or lower respiratory tract infection within 4 weeks of enrollment
Description

Upper Respiratory Infection | Lower respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the investigator's opinion would compromise participant's safety and/or compliance with the study procedures
Description

Alcohol consumption | Barbiturates | Amphetamines | Recreational Drugs | Narcotic Drugs | Substances compromise Patient safety | Substances compromise Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0004745
UMLS CUI [3]
C0002667
UMLS CUI [4]
C0242508
UMLS CUI [5]
C0237425
UMLS CUI [6,1]
C0439861
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C1113679
UMLS CUI [7,1]
C0439861
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C0525058
participants with a known history of human immunodeficiency virus type 1 (hiv-1) or hiv-2 infection, or with a known history of hepatitis a, b, or c virus infection at study screening
Description

HIV-1 infection | HIV-2 infection | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C2363741
UMLS CUI [2]
C0854094
UMLS CUI [3]
C0019159
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
female participants who are breastfeeding at screening or having a positive urine pregnancy test at screening
Description

Breast Feeding | Urine pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0430059
b. atopic mild to mild-persistent asthmatic participants:
Description

Mild asthma Atopic | Mild persistent asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0581124
UMLS CUI [1,2]
C0392707
UMLS CUI [2]
C1960046
hospitalization or treatment in an emergency care facility for asthma during the last 3 years
Description

Hospitalization Asthma | Emergency treatment Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0013969
UMLS CUI [2,2]
C0004096
participants using nasal corticosteroids on a daily basis in the 4 weeks prior to enrollment
Description

Adrenal Cortex Hormones Nasal Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522019
UMLS CUI [1,3]
C0332173
participants who have received allergen immunotherapy in the last 2 years
Description

Allergen Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0162352
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Similar models

Eligibility Healthy NCT02243189

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT02243189
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Mild asthma Atopic | Mild persistent asthma
Item
a. healthy participants and atopic mild to mild-persistent asthmatic participants:
boolean
C1708335 (UMLS CUI [1])
C0581124 (UMLS CUI [2,1])
C0392707 (UMLS CUI [2,2])
C1960046 (UMLS CUI [3])
Non-smoker | Tobacco use Irregular | Refrain from Smoking Willing
Item
participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the weekend as part of social gathering) for at least 3 months prior to screening, according to the participant's self-reported medical history. participants should be willing to (continue to) abstain from smoking from screening until completion of the last study related activity
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C0205271 (UMLS CUI [2,2])
C4086797 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Body mass index
Item
participants must have a body mass index (bmi: weight in kilogram [kg] divided by the height in square meter [m^2]) of 18.0 to 30.0 kg/m^2, extremes included
boolean
C1305855 (UMLS CUI [1])
12 lead ECG Normal | Normal sinus rhythm | Heart rate | QTcF - Fridericia's Correction Formula | QRS interval | PR interval duration
Item
participants must have a normal 12-lead electrocardiogram (ecg) at screening including normal sinus rhythm (heart rate between 40 and 100 beats per minute [bpm]); qt interval corrected for heart rate according to fridericia (qtcf) interval less than and equal to (<=) 450 milliseconds (ms); qrs interval lower than 120 ms; and pr interval <=220 ms
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0232202 (UMLS CUI [2])
C0018810 (UMLS CUI [3])
C1882513 (UMLS CUI [4])
C0520880 (UMLS CUI [5])
C0429024 (UMLS CUI [6])
Healthy Volunteers | Exception Asthma | Exception Hypersensitivity | Exception Mild asthma Atopic | Exception Mild persistent asthma | Abnormality Clinical Absent | Evaluation procedure | Physical Examination | Medical History | Vital signs | Systolic Pressure | Diastolic blood pressure | Pulse Rate | Respiratory rate | Body Temperature | Normal blood biochemistry | Hematologic Tests
Item
participants must be healthy, with the exception of findings related to asthma and allergy in atopic mild to mild-persistent asthmatic participants, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs (systolic blood pressure [bp], diastolic bp, pulse rate, respiratory rate, and body temperature), and the results of blood biochemistry and hematology tests performed at screening
boolean
C1708335 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0581124 (UMLS CUI [4,2])
C0392707 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1960046 (UMLS CUI [5,2])
C1704258 (UMLS CUI [6,1])
C0205210 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1261322 (UMLS CUI [7])
C0031809 (UMLS CUI [8])
C0262926 (UMLS CUI [9])
C0518766 (UMLS CUI [10])
C0871470 (UMLS CUI [11])
C0428883 (UMLS CUI [12])
C0232117 (UMLS CUI [13])
C0231832 (UMLS CUI [14])
C0005903 (UMLS CUI [15])
C4229061 (UMLS CUI [16])
C0018941 (UMLS CUI [17])
Protocol Compliance
Item
participants must be willing/ able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
boolean
C0525058 (UMLS CUI [1])
Mild asthma Atopic | Mild persistent asthma
Item
b. atopic mild to mild-persistent asthmatic participants:
boolean
C0581124 (UMLS CUI [1,1])
C0392707 (UMLS CUI [1,2])
C1960046 (UMLS CUI [2])
Mild asthma | Mild persistent asthma
Item
participants with investigator-diagnosed mild to mild-persistent asthma based on the guidelines for the diagnosis and management of asthma
boolean
C0581124 (UMLS CUI [1])
C1960046 (UMLS CUI [2])
Allergen Profile Established | Skin tests | Allergic Reaction Allergens Specific
Item
participants having a well-established allergen profile (participants have been previously skin tested and, by history, have allergic responses to specific allergens)
boolean
C0002092 (UMLS CUI [1,1])
C1979963 (UMLS CUI [1,2])
C0443211 (UMLS CUI [1,3])
C0037296 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C0002092 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
FEV1
Item
participants with forced expiratory volume in 1 second (fev1) greater than (>) 70 percent (%) of predicted at baseline
boolean
C0849974 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Healthy Volunteers | Mild asthma Atopic | Mild persistent asthma
Item
a. healthy participants and atopic mild to mild-persistent asthmatic participants:
boolean
C1708335 (UMLS CUI [1])
C0581124 (UMLS CUI [2,1])
C0392707 (UMLS CUI [2,2])
C1960046 (UMLS CUI [3])
Nasal abnormality | Operation on nose | Sinus operation
Item
participants having a significant (by the assessment of the investigator) nasal abnormality and/or has a history of nasal or sinus surgery within 12 months of enrollment
boolean
C0265736 (UMLS CUI [1])
C0188970 (UMLS CUI [2])
C0748725 (UMLS CUI [3])
Upper Respiratory Infection | Lower respiratory tract infection
Item
participants having an upper or lower respiratory tract infection within 4 weeks of enrollment
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Alcohol consumption | Barbiturates | Amphetamines | Recreational Drugs | Narcotic Drugs | Substances compromise Patient safety | Substances compromise Protocol Compliance
Item
participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the investigator's opinion would compromise participant's safety and/or compliance with the study procedures
boolean
C0001948 (UMLS CUI [1])
C0004745 (UMLS CUI [2])
C0002667 (UMLS CUI [3])
C0242508 (UMLS CUI [4])
C0237425 (UMLS CUI [5])
C0439861 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
C0439861 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
HIV-1 infection | HIV-2 infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
participants with a known history of human immunodeficiency virus type 1 (hiv-1) or hiv-2 infection, or with a known history of hepatitis a, b, or c virus infection at study screening
boolean
C2363741 (UMLS CUI [1])
C0854094 (UMLS CUI [2])
C0019159 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Breast Feeding | Urine pregnancy test positive
Item
female participants who are breastfeeding at screening or having a positive urine pregnancy test at screening
boolean
C0006147 (UMLS CUI [1])
C0430059 (UMLS CUI [2])
Mild asthma Atopic | Mild persistent asthma
Item
b. atopic mild to mild-persistent asthmatic participants:
boolean
C0581124 (UMLS CUI [1,1])
C0392707 (UMLS CUI [1,2])
C1960046 (UMLS CUI [2])
Hospitalization Asthma | Emergency treatment Asthma
Item
hospitalization or treatment in an emergency care facility for asthma during the last 3 years
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0013969 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Adrenal Cortex Hormones Nasal Daily
Item
participants using nasal corticosteroids on a daily basis in the 4 weeks prior to enrollment
boolean
C0001617 (UMLS CUI [1,1])
C1522019 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Allergen Immunotherapy
Item
participants who have received allergen immunotherapy in the last 2 years
boolean
C0162352 (UMLS CUI [1])
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