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

NCT00595491 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2025-09-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Benjamin Medoff

    lead OTHER

Principal Investigators

  • Benjamin D Medoff, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595491 on ClinicalTrials.gov