400 asthma patients tracked for 5 years to uncover environmental triggers
NCT ID NCT02327897
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 8 times
Summary
This study follows 400 adults aged 18–60 with moderate-to-severe asthma for up to 5 years. Researchers collect blood, urine, stool, dust, saliva, and lung samples at regular visits to see how bacteria and other environmental factors affect asthma symptoms and flare-ups. The goal is to gather data for future research, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2015
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. Exclusion Criteria 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 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: * 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 * Body weight \<50 kg (\<110 lbs) * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NIEHS Clinical Research Unit (CRU)
RECRUITINGResearch Triangle Park, North Carolina, 27709, United States
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