Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
AsthmaAllergies
Interventions
BIOLOGICAL

Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage

On the first bronchoscopy day,BAL will first be performed in the lingual without instillation of diluent or allergen. A 2ml aliquot of isotonic diluent is instilled into the right upper lobe.The procedure is repeated in the right middle lobe with instillation of 2ml of standardized cat or mite allergen solution. A test dose concentration of allergen is administered first consisting of 2 ml of allergen at 1/10th(Cat,D.farinae)or 1/30th(D.pteronyssinus)the threshold concentration.If on visual inspection through the bronchoscope there is no evidence of mucosal inflammation after 2 minutes a second segmental allergen challenge will be done in the right middle lobe using 2ml of full-dose allergen at the threshold concentration(Cat,D.farinae)or 1/3 the threshold concentration(D.pteronyssinus). This dose will be predetermined by quantitative skin prick testing.A second bronchoscopy is performed 24 hours after delivery of allergen extract and diluent to obtain BAL fluid from the RUL and RML.

PROCEDURE

Phlebotomy

200 (40 teaspoons) ml of blood will be obtained from the subjects to collect different leukocyte populations. A second 200 ml of blood will be obtained from the Track 2 subjects 4 weeks later for isolation of T lymphocytes for functional studies.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Andrew D. Luster, M.D.,Ph.D.

OTHER

NCT01711593 - Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma | Biotech Hunter | Biotech Hunter