NCT02327897Recruiting
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Natural History of Asthma With Longitudinal Environmental Sampling
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 30 Dec 2014
- Start date
- 10 Sept 2015
- Primary completion date
- 1 Apr 2030
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Diseases
- Asthma
- NCT number
- NCT02327897
What you commit to
- Study type: Observational
- Planned participants: 400
- From 10 Sept 2015 to the primary completion date, 1 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Facial deformity, major facial surgery
- Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit
Other illness
- 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.
- 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
- Bronchoscopy Visit 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 visit:
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy
- Bleeding disorders
- Allergy or history of adverse reactions to lidocaine
Lab values
- 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 Visit 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.
Age
- Pregnancy, as indicated by urine pregnancy test, if of childbearing age and/or ability contraindication
Other
- Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
- piCO Smokealyzer value of \>11ppm
- Severe persistent asthma, defined as by ATS-ERS criteria.
- Temperature \>37.6 (Infinite)C; blood pressure \<90/50 mm Hg or \>160/100 mm Hg; pulse rate \<50 or \>100 beats/minute
- Body weight \<50 kg (\<110 lbs)
Criteria the registry did not label
- Inclusion Criteria
- 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.
- Bronchoscopy Visit 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 visit.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIEHS Clinical Research Unit (CRU) Coordinator of this site? Confirm its status | Research Triangle Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.