Age | Well adult
Item
generally healthy, male and female adults, 18-55 years of age at screening
boolean
C0001779 (UMLS CUI [1])
C0686750 (UMLS CUI [2])
Mild persistent asthma | Moderate persistent asthma | Adrenergic beta-Agonists
Item
with mild-to-moderate persistent asthma for at least 6 months prior to screening, and having used inhaled β-agonist(s) for asthma control
boolean
C1960046 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C0001644 (UMLS CUI [3])
FEV1
Item
demonstrating a screening baseline fev1 at 50.0 - 85.0 percent of predicted normal
boolean
C0748133 (UMLS CUI [1])
airway disease Reversibility | FEV1 | Proventil | Metered Dose Inhaler
Item
demonstrating a ≥ 15.0% airway reversibility in fev1 within 30 min after inhaling 2 actuations of proventil® mdi (180 mcg) at screening
boolean
C0699949 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C0699770 (UMLS CUI [3])
C0993596 (UMLS CUI [4])
Peak inspiratory flow rate
Item
demonstrating peak inspiratory flow rate (pif) within 80-150 l/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
boolean
C0429742 (UMLS CUI [1])
Use of Dry Powder Inhaler (device) | Use of Metered Dose Inhaler
Item
demonstrating proficiency in the use of a dpi and an mdi after training
boolean
C1524063 (UMLS CUI [1,1])
C1967611 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0993596 (UMLS CUI [2,2])
Childbearing Potential | Not pregnant (finding) | Breast Feeding | Contraceptive methods | Sexual Abstinence | Contraception, Barrier
Item
females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
boolean
C3831118 (UMLS CUI [1])
C0232973 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
Informed consent
Item
having properly consented to participate in the trial
boolean
C0021430 (UMLS CUI [1])
smoking cigarettes: ____ pack-years history | Former smoker
Item
a smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to screening
boolean
C2230126 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Upper Respiratory Infections | Lower respiratory tract infection
Item
upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to screening
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Exacerbation of asthma | Emergency Care | Hospitalization
Item
asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to screening
boolean
C0349790 (UMLS CUI [1])
C1527398 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
Respiration Disorders Affecting Investigational New Drugs | Cystic Fibrosis | Bronchiectasis | Tuberculosis | Pulmonary Emphysema
Item
any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
boolean
C0035204 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0010674 (UMLS CUI [2])
C0006267 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0034067 (UMLS CUI [5])
Cardiovascular Diseases | Hypertensive disease | Tachyarrhythmia | Bradyarrhythmia | Hematological Disease | Kidney Diseases | nervous system disorder | Liver diseases | Endocrine System Diseases | Mental disorders | Malignant Neoplasms
Item
concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
boolean
C0007222 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0080203 (UMLS CUI [3])
C0079035 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0004936 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
Hypersensitivity Investigational New Drugs | Proventil HFA | Albuterol | Sulfates, Inorganic | Lactose | Milk Proteins | HFA 134a | Oleic Acid | Ethanol
Item
known intolerance or hypersensitivity to any of the ingredients of the study drug dpi or proventil® hfa mdi (i.e., albuterol, sulfate, lactose, milk protein, hfa-134a, oleic acid, and ethanol)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0722880 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0001927 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038720 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0022949 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0026138 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0298501 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0028928 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0001962 (UMLS CUI [9,2])
Unifocal PVCs | Multifocal PVCs | Electrocardiography
Item
baseline ecg at screening or visit 1 showing any single or multiple premature ventricular contractions (pvc)
boolean
C0264902 (UMLS CUI [1])
C0264903 (UMLS CUI [2])
C1623258 (UMLS CUI [3])
QTc | Electrocardiography
Item
baseline ecg at screening or visit 1 with a confirmed (through performing a second ecg) qtc reading greater than 450ms
boolean
C0860814 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
Pharmaceutical Preparations no permission
Item
use of prohibited drugs or failure to observe the drug washout restrictions
boolean
C0013227 (UMLS CUI [1,1])
C3242263 (UMLS CUI [1,2])
Study Subject Participation Status
Item
having been on other clinical drug/device studies in the last 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])