Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Treatment completed | Exacerbation of asthma Clinical Trial | Investigational New Drugs Dose Quantity | Pulmonary function Clinical Trial
Item
patient must have completed treatment in a previous cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
boolean
C0580352 (UMLS CUI [1])
C0349790 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024119 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Protocol Compliance | Patient Available Clinical Study Follow-up
Item
the patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Inclusion criteria Additional
Item
other criteria may apply; please contact the investigator for more information.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Comorbidity Interferes with Study Protocol | Comorbidity Interferes with Protocol Compliance | Comorbidity compromises Patient safety
Item
the patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
Interference Lung disease | Chronic Obstructive Airway Disease | Pulmonary Fibrosis | Carcinoma of lung
Item
the patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
boolean
C0521102 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0684249 (UMLS CUI [4])
Tobacco use
Item
the patient is a current smoker.
boolean
C0543414 (UMLS CUI [1])
Protocol Compliance Poor Expected
Item
the patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Aggravating factors Poorly controlled | Gastroesophageal reflux disease
Item
the patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [gerd]).
boolean
C0436331 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0017168 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Vaginal Spermicides | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Transdermal contraception | Contraceptive implant | Injectable contraception | Contraception, Barrier
Item
female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [iud], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0087145 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1168146 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0004764 (UMLS CUI [11])
Communicable Disease Excludes Assessment Asthma | Disease Excludes Assessment Asthma
Item
the patient has a current infection or disease that may preclude assessment of asthma.
boolean
C0009450 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0004096 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0004096 (UMLS CUI [2,4])
Exclusion Criteria Additional
Item
other criteria may apply; please contact the investigator for more information.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])