Is NCT02327897 recruiting in Research Triangle Park, NC?

Yes, NCT02327897 is currently recruiting participants at its Research Triangle Park, NC location. This asthma clinical trial is actively enrolling qualified participants.

How do I join the asthma clinical trial in Research Triangle Park?

To join this clinical trial in Research Triangle Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Research Triangle Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Asthma Clinical Trial in Research Triangle Park, NC

About This Asthma Study in Research Triangle Park

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.

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Research Triangle Park?

Yes, this clinical trial (NCT02327897) has an active research site in Research Triangle Park, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Asthma Treatment Options in Research Triangle Park, NC

If you're searching for asthma treatment options in Research Triangle Park, NC, this clinical trial (NCT02327897) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Research Triangle Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced asthma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all asthma clinical trials near you to find additional studies recruiting in your area.

Asthma Clinical Trial in Research Triangle Park, NC

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