Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Benjamin Medoff
Study ID
NCT00595491
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage — BIOLOGICAL
    Bronchoalveolar lavage is performed in the lingula without instillation of diluent or allergen. A 2ml aliquot of diluent is instilled into the right upper lobe. The procedure is repeated in the right middle lobe with instillation of 2ml of Cat or Mite allergen. A test dose of allergen is administered first. This will consist of 2ml allergen at 1/10th the threshold concentration for Cat or DF Mite Allergen or at 1/30th the threshold concentration for DP Mite Allergen. If on visual inspection through the bronchoscope there is no evidence of reaction to the test dose, a 2nd allergen challenge is done in the right middle lobe using 2ml of full-dose allergen. After a 1,6, or 24hr recovery period, a single 2nd bronchoscopy is performed after delivery of allergen extract and diluent and 1 Tbsp of blood is obtained. Bronchoalveolar lavage will be obtained from the lobes in which the diluent and allergen were instilled. OFDI and endobronchial brushing of the airways will also be performed.

Study Details

Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma.

Key Dates

Start date
Jan 31, 2008
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
313 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: allergic asthmatic, allergic nonasthmatic, healthy
    Adults who are allergic asthmatics, allergic nonasthmatics, or healthy controls will receive segmental allergen challenge to the lung

Primary Outcome Measure

airway inflammation [ Time Frame: 1,6, or 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Daniel L Hamilos
[email protected]
617-726-5090
Benjamin D Medoff
[email protected]
617-726-6695
Andrew D Luster, MD, Ph.D (SUB_INVESTIGATOR)
Daniel L Hamilos, MD (SUB_INVESTIGATOR)
Benjamin D Medoff, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Massachusetts General Hospital· Boston, MA

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