Lung-Resident Memory Th2 Cells in Asthma
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|ClinicalTrials.gov Identifier: NCT03455959|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma, Allergic||Procedure: Bronchoscopy/BAL Procedure: Airway Brushing Procedure: Endobronchial Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single time point study with all information obtained at the time of bronchoscopy|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Lung-Resident Memory Th2 Cells in Asthma|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Allergic Asthmatic or Healthy Control Adults
Allergic Asthmatic or Healthy Control Adults will undergo Bronchoscopy/BAL, airway brushing, and endobronchial biopsy
Participants will receive 2-3 inhalations(90 ug ea)of albuterol to minimize bronchoconstriction.Medication includes midazolam by intravenous injection, and fentanyl by intravenous injection as judged necessary.4% lidocaine is delivered via atomizer spray to the oral pharynx for local anesthesia.1% lidocaine is delivered through the bronchoscope to the vocal cords and lung segments for local anesthesia.The bronchoscope is then passed through the vocal cords into the trachea.Throughout the procedure,all participants will have continuous blood pressure,heart rate,and oxygen saturation monitoring.Participants will be instructed to relate any discomfort or problems through a series of standardized hand signals.Once in the lung, aliquots of sterile saline are instilled into a subsegment of the lingula of the left lung and withdrawn into a trap by gentle suction. Then,the bronchoscope is passed into a subsegment of the right upper lobe and the right middle lobe where the lavage is repeated.
Procedure: Airway Brushing
After completion of the BALs, endobronchial brushing of the airways will be performed using the airway brushings with a Conmed Harrell™ 4 mm unsheathed cytology brush. Upon completing the brushing the investigators remove the bronchoscope with the brush in place to avoid shearing off isolated cells. The brush will be gently glided back and forth on the airway epithelium 10 times in 2 different locations within the same airway. The brush is then placed in media and flicked to remove the cells. There is some airway bleeding caused by the procedure, and participants are made aware that they may cough up small amounts of blood for 24-48 hours following the procedure.
Procedure: Endobronchial Biopsy
In some subjects, after completion of the BALs, endobronchial biopsies of the airways will be performed to compare and contrast the findings on Trm from the bronchial brushings. For the biopsy, the investigators will use a standard alligator jaw forceps that effectively samples the airway wall. The forceps will be placed into the lavaged segments of the lung only (lingula or right middle lobe) and then six biopsies will be taken at the segmental and subsegmental levels. Tissue pieces will be immediately placed into 4% freshly defrosted paraformaldehyde for tissue processing.
- The transcriptional profile of Th2-Trm recovered from the airway mucosa [ Time Frame: This is a single time point study with all information obtained at the time of bronchoscopy defined as Day 0. ]The investigators will determine the transcriptional profile of Th2-Trm recovered from the airway mucosa of humans with asthma via single-cell RNA-seq analysis to define the phenotype of human Th2-Trm. The T cells will be recovered from airway bronchial brushing samples of patients with allergic asthma and allergy to an indoor allergen, and the investigators will obtain comparative samples from nonallergic healthy control subjects.
- The phenotype of Th2-Trm recovered from the airway mucosa [ Time Frame: This is a single time point study with all information obtained at the time of bronchoscopy defined as Day 0. ]The investigators will determine the phenotype of Th2-Trm recovered from the airway mucosa of humans with asthma via single-cell RNA-seq analysis to define the phenotype of human Th2-Trm. The T cells will be recovered from airway bronchial brushing samples of patients with allergic asthma and allergy to an indoor allergen, and the investigators will obtain comparative samples from nonallergic healthy control subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455959
|Contact: Daniel L Hamilosfirstname.lastname@example.org|
|Contact: Ben D Medoff||(617) email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02116|
|Contact: Daniel L Hamilos, MD 617-726-5090 firstname.lastname@example.org|
|Principal Investigator:||Andrew D Luster||MGH|