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Protocol Details

Natural History of Asthma with Longitudinal Environmental Sampling

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Environmental Health Sciences (NIEHS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 70

Referral Letter Required


Population Exclusion(s)


Special Instructions

Currently Not Provided


Atopic Asthma;
Disease Progression

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Environmental Health Sciences


- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma.


- Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or breastfeeding.


- Partaicipants will complete a medical history form before the first visit.

- Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples.

- Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys.

- Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant.

- Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.

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Inclusion Criteria

Participants must meet all of the following criteria for enrollment:

1. Male or female, 18 to 60 years of age

2. Must have clinical evidence of moderate-severe atopic asthma:

-self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms)

within the past year, and

-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

-no other diagnosis that could explain symptoms.

If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge.

3. Permanently resides within 50 miles of the CRU.

4. Able to present a valid government issued form of identification for entry to the NIEHS campus

5. Able to receive asthma treatment medication(s) via mail

6. Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol

7. Access to a vacuum cleaner with a detachable hose component

Bronchoscopy Sub-Study Inclusion Criterion

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.

Exclusion Criteria

Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:

1. Women who are pregnant or lactating at the time of screening will not be encouraged to enroll. However, if a woman is found to be pregnant at a screening or baseline visit, she may remain in the study but will not be eligible for the methacholine challenge or bronchoscopy sub-study until no longer pregnant or breastfeeding (this exclusion is in place because methacholine may pose an undue risk on the unborn fetus or nursing babies; 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).

2. Current smoker, significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes.

3. piCO Smokealyzer value of >11ppm

4. History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension

5. Allergy or history of adverse reactions to methacholine

6. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures

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

Bronchoscopy Sub-Study Exclusion Criteria

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:

1. Pregnant, as indicated by urine pregnancy test

2. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy

3. Bleeding disorders

4. Facial deformity, major facial surgery

5. Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit

6. Severe persistent asthma, defined as by ATS-ERS criteria.

7. Allergy or history of adverse reactions to lidocaine

8. Temperature >37.6 (Infinite)C; blood pressure <90/50 mm Hg or >160/100 mm Hg; pulse rate <50 or >100 beats/minute

9. Body weight <50 kg (<110 lbs)

10.The following abnormal lab values (values obtained during clinical assessment):

-Platelet count <100,000 per microliters

-White blood cells count <3000 per microliters

-Absolute neutrophil count <1000 per microliters

-Hematocrit <35% for both female and male

-Prothrombin time (PT) / abnormal international normalized ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges

-Serum creatinine >1.4 mg/dL

If a participant is recruited for the Bronchoscopy Sub-Study but does not have current lab values (within 4 weeks), the participant may be asked to return to the CRU for an additional blood draw in order to run the requisite clinical assessments for safety purposes. The participant will be compensated for the additional visit. This is anticipated to be a rare occurrence, as the study team will make all efforts to schedule and complete the bronchoscopy procedure while the lab results are current.

Participants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Stavros Garantziotis, M.D.
National Institute of Environmental Health Sciences (NIEHS)
BG 109 RM 109
(984) 287-4412

Nicole Edwards
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Environmental Health Sciences
BG 109 RM 114 MSC CU-01
P.O. Box 12233
Research Triangle Park, NC 27709
(984) 287-4416

Lisa B. Barber, MEd
Building 109 - Modular Clinic, 121
111 T W Alexander Dr
Research Triangle Prk, NC, 27709
(984) 287-4410

Clinical Trials Number:


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