Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Asthma | Stable status
Item
asthma diagnosis: the patient has a diagnosis of asthma as defined by the national institute of health (nih). the asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0027468 (UMLS CUI [2])
Severe persistent asthma | FEV1
Item
severity of disease: the patient has persistent asthma, with a forced expiratory volume in 1 second (fev1) 40 percent to 90 percent of the value predicted for age, height, and sex at screening visit (sv)
boolean
C1960048 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Therapeutic procedure | Asthma | inhaled steroids | Fluticasone propionate | Steroid therapy | Adrenergic beta-2 Receptor Agonists | salmeterol
Item
current asthma therapy: the patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ics) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ics plus a long-acting beta2-agonist (laba) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
C2936789 (UMLS CUI [5])
C0073992 (UMLS CUI [6])
disease reversibility | FEV1 | Albuterol | HYDROFLUOROALKANE
Item
reversibility of disease: the patient has demonstrated at least 12% reversibility of fev1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (hfa) mdi (90 mcg ex-actuator) or equivalent at screening visit or on retesting.
boolean
C0679253 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0001927 (UMLS CUI [3])
C1721232 (UMLS CUI [4])
Inclusion criteria | Other
Item
other criteria apply, please contact the investigator for more information
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Asthma | Life Threatening | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions
Item
the patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0020440 (UMLS CUI [3])
C0162297 (UMLS CUI [4])
C1843573 (UMLS CUI [5])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
the patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). any patient becoming pregnant during the study will be withdrawn from the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity | Adrenal Cortex Hormones | Investigational New Drugs
Item
the patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Tobacco use | Cigarette | Cigars | Oral Tobacco | pipe tobacco
Item
the patient has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
boolean
C0543414 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678446 (UMLS CUI [3])
C0008038 (UMLS CUI [4])
C0678447 (UMLS CUI [5])
Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization | Asthma
Item
the patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before screening visit.
boolean
C0349790 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
Disease | Study Subject Participation Status | Limited
Item
the patient has historical or current evidence of a clinically significant disease. significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Exclusion Criteria | Other
Item
other criteria apply, please contact the investigator for more information
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])