Study Subject Participation Status | Inclusion
Item
participants must meet all of the following criteria for enrollment:
boolean
C2348568 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Age
Item
1. male or female, 18 to 60 years of age
boolean
C0001779 (UMLS CUI [1])
Moderate persistent allergic asthma | Severe persistent allergic asthma
Item
2. must have clinical evidence of moderate-severe atopic asthma:
boolean
C4039651 (UMLS CUI [1])
C4041248 (UMLS CUI [2])
Asthma Symptoms | Wheezing | Chest tightness | Dyspnea | Nocturnal cough
Item
self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) for at least one year, and
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0043144 (UMLS CUI [2])
C0232292 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0231912 (UMLS CUI [5])
Pulmonary methacholine challenge test Positive | FEV1 | inhaled steroids | FEV1 post bronchodilator | Forced vital capacity - finding | Bronchodilator Agents
Item
a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (pc20 fev1) < 16 mg/ml for participants on inhaled corticosteroids and < 8 mg/ml for participants not on inhaled corticosteroids] or postbronchodilator fev1 with at least 12% or 200 ml increase in fev1 or forced volume vital capacity (fvc) on bronchodilator challenge, and
boolean
C1096470 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0748133 (UMLS CUI [4,1])
C2599594 (UMLS CUI [4,2])
C1287681 (UMLS CUI [5])
C0006280 (UMLS CUI [6])
Other Diagnosis | Symptoms
Item
no other diagnosis that could explain symptoms.
boolean
C0011900 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2])
Ability travel | Clinic / Center - Research North Carolina
Item
3. able to travel to the niehs cru, in research triangle park, north carolina, for required study visits
boolean
C0085732 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C1552456 (UMLS CUI [2,1])
C0028407 (UMLS CUI [2,2])
Human Identification Card (document) | Government
Item
4. able to present a valid government issued form of identification for entry to the niehs campus
boolean
C0242954 (UMLS CUI [1,1])
C3275277 (UMLS CUI [1,2])
C0018104 (UMLS CUI [2])
Therapeutic procedure Asthma | Pharmaceutical Preparations Mail
Item
5. able to receive asthma treatment medication(s) via mail
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0024492 (UMLS CUI [2,2])
Compliance behavior | Medication regimen | Diet | Life Style
Item
6. willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol
boolean
C1321605 (UMLS CUI [1])
C0237125 (UMLS CUI [2])
C0012155 (UMLS CUI [3])
C0023676 (UMLS CUI [4])
Access Vacuum Cleaners
Item
7. access to a vacuum cleaner with a detachable hose component
boolean
C0444454 (UMLS CUI [1,1])
C0392308 (UMLS CUI [1,2])
Bronchoscopy | Inclusion
Item
bronchoscopy sub-study inclusion criterion
boolean
C0006290 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Ability Fasting 6 Hours
Item
in addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy sub-study.
boolean
C0085732 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C1292428 (UMLS CUI [1,3])
Exclusion Criteria
Item
participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
boolean
C0680251 (UMLS CUI [1])
Pregnancy | Breast Feeding | Methacholine challenge | Withdrawn | Study Subject Participation Status | Bronchoscopy
Item
1. women who are pregnant or lactating at the time of screening (this exclusion is in place because certain enrollment procedures, may pose an undue risk on the unborn fetus; women may rescreen at a later date once no longer pregnant or breastfeeding; women who are pregnant or lactating at the time of the baseline visit and are scheduled to complete the methacholine challenge will be withdrawn due to the potential risk to the fetus; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430567 (UMLS CUI [3])
C0424092 (UMLS CUI [4])
C2348568 (UMLS CUI [5])
C0006290 (UMLS CUI [6])
Current Smoker | Second hand smoke exposure | Urine cotinine measurement | smoking cigarettes: ____ pack-years history | Electronic Cigarettes
Item
2. current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/ml at screening), or a history of smoking greater than 5 pack years. smoking encompasses all inhaled products, including e-cigarettes.
boolean
C3241966 (UMLS CUI [1])
C1545750 (UMLS CUI [2])
C1278256 (UMLS CUI [3])
C2230126 (UMLS CUI [4])
C3849993 (UMLS CUI [5])
Carbon monoxide analyzer Measurement
Item
3. pico smokealyzer value of > 11ppm
boolean
C0179602 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Comorbidity | Chronic Obstructive Airway Disease | Cystic Fibrosis | Pulmonary Emphysema | Bronchiectasis | Pulmonary Fibrosis | Sarcoidosis | Angina, Unstable | Pulmonary Hypertension
Item
4. history of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (cf), emphysema, non-cf bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension
boolean
C0009488 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0034067 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0034069 (UMLS CUI [6])
C0036202 (UMLS CUI [7])
C0002965 (UMLS CUI [8])
C0020542 (UMLS CUI [9])
Hypersensitivity Methacholine | Adverse reactions Methacholine
Item
5. allergy or history of adverse reactions to methacholine
boolean
C0020517 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0600370 (UMLS CUI [2,2])
Disease Study Subject Participation Status Limited
Item
6. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Comorbidity Affecting Global Health | Comorbidity Affecting Continuance of life | Deep Vein Thrombosis | Pulmonary Embolism | Congestive heart failure New York Heart Association class III/IV | Malignant Neoplasms Therapeutic procedure
Item
7. comorbid diseases that affect global health or survival- such as dvt, pulmonary embolism, class iii - iv congestive heart failure, or a malignancy under treatment
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1456573 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0038952 (UMLS CUI [2,3])
C0149871 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0278962 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
Bronchoscopy Study Exclusion Criteria
Item
bronchoscopy sub-study exclusion criteria
boolean
C0006290 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
Study Subject Participation Status Bronchoscopy Study
Item
in addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy sub-study:
boolean
C2348568 (UMLS CUI [1,1])
C0006290 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
Pregnancy Urine pregnancy test
Item
1. pregnant, as indicated by urine pregnancy test
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Disease Study Subject Participation Status Limited | Bronchoscopy
Item
2. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0006290 (UMLS CUI [2])
Blood Coagulation Disorders
Item
3. bleeding disorders
boolean
C0005779 (UMLS CUI [1])
facial deformity | facial surgery
Item
4. facial deformity, major facial surgery
boolean
C1385263 (UMLS CUI [1])
C2224535 (UMLS CUI [2])
Exacerbation of asthma | Respiratory Tract Infections
Item
5. asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit
boolean
C0349790 (UMLS CUI [1])
C0035243 (UMLS CUI [2])
Severe persistent asthma
Item
6. severe persistent asthma, defined as by ats-ers criteria.
boolean
C1960048 (UMLS CUI [1])
Hypersensitivity Lidocaine | Adverse reactions Lidocaine
Item
7. allergy or history of adverse reactions to lidocaine
boolean
C0020517 (UMLS CUI [1,1])
C0023660 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0023660 (UMLS CUI [2,2])
Temperature | Blood Pressure | Pulse Rate
Item
8. temperature > 37.6 (infinite)c; blood pressure < 90/50 mm hg or > 160/100 mm hg; pulse rate < 50 or > 100 beats/minute
boolean
C0039476 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C0232117 (UMLS CUI [3])
Body Weight
Item
9. body weight < 50 kg (< 110 lbs)
boolean
C0005910 (UMLS CUI [1])
Laboratory test result abnormal
Item
10. the following abnormal lab values (values obtained during clinical assessment):
boolean
C0438215 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 150,000 per l
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cells count < 3000 per l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count < 1000 per l
boolean
C0948762 (UMLS CUI [1])
Hematocrit procedure | Gender
Item
hematocrit < 35% for both female and male
boolean
C0018935 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Prothrombin time assay INR - international normal ratio abnormal | Partial thromboplastin time finding
Item
prothrombin time (pt) / abnormal international normalized ratio (inr) and partial prothromboplastin time (ptt) based on reference laboratory established reference ranges
boolean
C0033707 (UMLS CUI [1,1])
C0580417 (UMLS CUI [1,2])
C1531697 (UMLS CUI [2])
Creatinine measurement, serum (procedure)
Item
serum creatinine > 1.4 mg/dl
boolean
C0201976 (UMLS CUI [1])
Bronchial Spasm | Bronchoscopy day
Item
participants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.
boolean
C0006266 (UMLS CUI [1])
C0006290 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])