RecruitingPhase not listed

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Natural History of Asthma With Longitudinal Environmental Sampling

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Physical exams, Questionnaires, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "They will fill out surveys. * Participants will have visits every 6 months for 5 years."
  • "They will have medical history, physical exam, and lung tests."
  • "They will have urine tests to check for pregnancy and tobacco exposure."
  • "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 and, if consented, through the use of home devices."
  • "The samples and survey information collected may be used to explore the microbiological and genetic influences of atopic asthma."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how bacteria and other things in the environment may affect asthma. It is for nonsmoking adults ages 18 to 60 with moderate to severe asthma. Participants have visits every 6 months for 5 years and collect some samples at home.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 60 years old.
  • Have moderate to severe allergic asthma, with symptoms in the past year and breathing tests that confirm asthma. No other illness can explain the symptoms.
  • Live permanently within 50 miles of the study clinic.
  • Have a valid government-issued ID to enter the study campus.
  • Be able to receive asthma medicines by mail.
  • Be willing to follow study instructions about medicines, diet, and daily habits.
  • Have access to a vacuum cleaner with a hose that can be removed.
  • For the optional lung scope visit, be able to go without food or drink for 6 hours, except a little water for approved medicines.

Who can't join

  • Currently smoke or use inhaled products, including e-cigarettes; have heavy secondhand smoke exposure; have smoked more than 5 pack-years, such as 1 pack a day for 5 years; or have a breath smoke test above the study limit.
  • Have certain other lung diseases, including COPD, cystic fibrosis, emphysema, damaged or scarred airways, sarcoidosis, or high blood pressure in the lungs; or have unstable chest pain from heart disease.
  • Have serious health problems, such as blood clots in deep veins or the lungs, severe heart failure, or cancer being treated.
  • Have an allergy or past bad reaction to methacholine, a drug used in breathing tests, or another condition that makes study tests unsafe.
  • Pregnancy or breastfeeding does not prevent joining the main study, but limits breathing challenge and lung scope tests.
  • For the optional lung scope test: have a bleeding disorder, major facial surgery or an unusual facial shape, a lidocaine allergy, or another condition that makes the test unsafe.
  • For the optional lung scope test: have severe ongoing asthma, an asthma flare or breathing infection within 4 weeks, or tightened airways on the test day.
  • For the optional lung scope test: weigh under 110 pounds, or have temperature, blood pressure, pulse, blood counts, blood clotting tests, or kidney tests outside the study's safety limits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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.

Study sites (1)

NC