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])
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])