NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897 | Recruiting

• 2 other identifiers: 15005815-E-0058
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- 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. Eligibility: \- Nonsmoking adults age 18 - 60 who have moderate to severe asthma. Design:

• Participants 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.

Conditions

Asthma

Keywords

Atopic Asthma; Exposures; Disease Progression; Natural History

Outcome Measures

Primary Outcomes (1)

• The overall goal is to study the natural history of atopic asthma, focusing on moderate to severe asthma. The primary objective is to collect prospective data and samples for future use to better understand the interaction between environmental ...

  Results will be evaluated in the context of the environmental exposures, clinical outcomes (symptoms, exacerbations, and quality of life), and response to therapy.

  End of Study

Study Arms (2)

asthmatic

study group

non-asthmatic

controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the population at large, including asthmatic participants who visit the CRU for on-going studies. Participants who have successfully completed other CRU studies may be recruited directly for this study. The study will be registered on clinicaltrials.gov. Local public health departments and other clinics may be contacted for help with recruitment of individuals with moderate to severe atopic asthma. In addition, if needed, the study may be advertised in local media outlets.

You may qualify if:

• Participants must meet all of the following criteria for enrollment:
• Male or female, 18 to 60 years of age
• 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.
• Permanently resides within 50 miles of the CRU.
• Able to present a valid government issued form of identification for entry to the NIEHS campus
• Able to receive asthma treatment medication(s) via mail
• Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol
• Access to a vacuum cleaner with a detachable hose component
• If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant.

You may not qualify if:

• Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
• 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.
• piCO Smokealyzer value of \>11ppm
• History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension
• Allergy or history of adverse reactions to methacholine
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
• Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment
• Pregnancy, as indicated by urine pregnancy test, if of childbearing age and/or ability contraindication
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy
• Bleeding disorders
• Facial deformity, major facial surgery
• Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit
• Severe persistent asthma, defined as by ATS-ERS criteria.
• Allergy or history of adverse reactions to lidocaine
• Temperature \>37.6 (Infinite)C; blood pressure \<90/50 mm Hg or \>160/100 mm Hg; pulse rate \<50 or \>100 beats/minute

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma; Disease Progression

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Stavros Garantziotis, M.D.

CONTACT

(984) 287-4412; garantziotis@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: December 31, 2014
• Study Start: September 10, 2015
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-02-19

Locations

US (1)