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NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ) Identifier:
First received: December 30, 2014
Last updated: November 4, 2015
Last verified: September 2015


- 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.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Natural History of Asthma With Longitudinal Environmental Sampling

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The overall goal is to study the natural history of bacteria and its impact on asthma [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2014
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: December 2029 (Final data collection date for primary outcome measure)
Detailed Description:

This study will be a prospective, longitudinal, observational, single-center, exploratory, natural history study to collect samples and data that will enable prospective explorations of the interaction between environmental exposures and disease progression over time in moderate-severe atopic asthmatics with persistent disease, and facilitate the formation of mechanistic hypotheses. Environmental and body microbiome samples will be collected and stored from participants for future correlation to effects on asthma symptoms and control.

Samples of blood, urine, DNA, saliva, sputum, stool, and household dust will be collected from approximately 200 participants, as well as quality of life information using asthma symptom questionnaires. Additionally, samples will be collected from the airways of approximately 20 participants enrolled in a bronchoscopy sub-study. The samples and survey information collected may be used to explore the microbiological and genetic influences of atopic asthma. Data from the analyses of these samples and survey responses may be evaluated in the context of the environmental exposures, clinical outcomes (symptoms, exacerbations, and quality of life), and response to therapy.

Male and female participants aged 18 to 60 years old with moderate-severe, symptomatic atopic asthma will be enrolled. Participants will be excluded from enrollment if they have a history of chronic obstructive pulmonary disease, cystic fibrosis, non-cystic fibrosis bronchiectasis, pulmonary fibrosis, pulmonary hypertension, emphysema, sarcoidosis, or unstable angina. Additionally, participants will be excluded if they have DVT, pulmonary embolism, class III IV congestive heart failure, or a malignancy under treatment. Current smokers, individuals who are allergic to methacholine, and women who are pregnant or breastfeeding, will not be eligible to enroll. Women who become pregnant or start breastfeeding after completing the screening and baseline visit assessments may continue their participation in the study but will not be eligible to participate in the bronchoscopy sub-study. Participants will be enrolled for five years and will receive standard of care asthma therapy as indicated. After the initial screening and baseline visits, participants will return for visits semi-annually and for sick visits as needed. Volunteers participating in the bronchoscopy sub-study will have an additional single visit shortly after completing the baseline visit.

This cohort of 200 participants will form the basis for future asthma study recruitment, and analysis of collected samples and data. Further expansion of the study beyond five years and 200 participants will be desirable if logistically possible.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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. Able to travel to the NIEHS CRU, in Research Triangle Park, North Carolina, for required study visits
  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 (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)
  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.
  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 L
    • White blood cells count < 3000 per L
    • Absolute neutrophil count < 1000 per L
    • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02327897

Contact: Lisa B Barber, MEd (919) 541-9839
Contact: Stavros Garantziotis, M.D. (919) 541-9859

United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Additional Information:
No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ) Identifier: NCT02327897     History of Changes
Other Study ID Numbers: 150058, 15-E-0058
Study First Received: December 30, 2014
Last Updated: November 4, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Atopic Asthma
Disease Progression

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on November 24, 2015