Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT00595491

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

Led by Benjamin Medoff · Updated on 2025-09-25

313

Participants Needed

1

Research Sites

1100 weeks

Total Duration

On this page

Sponsors

B

Benjamin Medoff

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Baseline FEV1 at least 75% of predicted value for allergic asthma subjects
  • Clinical history of allergic symptoms to cat or dust mite allergen with positive skin prick test
  • Life-long cigarette smoking less than 5 pack-years and none in past 5 years
  • Willing and able to give informed consent
  • Age between 18 and 50 years
  • For healthy controls: good overall health, age and sex matched, nonallergic, normal spirometry, and methacholine PC20 > 16 mg/ml
  • For allergic nonasthmatic subjects: history of allergic rhinitis, conjunctivitis, or contact allergy with positive allergy test to cat or dust mite
  • Baseline FEV1 and FVC at least 90% of predicted for allergic nonasthmatic subjects
  • Good general health for allergic nonasthmatic subjects
  • Desire to participate in an interview with principal investigator
Not Eligible

You will not qualify if you...

  • Pregnant, nursing, sexually active without contraception, or seeking pregnancy women
  • Spontaneous asthmatic episode or upper respiratory infection within past 6 weeks
  • Participation in drug or biologic research within past 30 days
  • Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam
  • Use of antihistamines within 7 days before screening
  • Presence of diabetes, heart failure, arrhythmias, stroke history, renal failure, anaphylaxis, or cirrhosis
  • Use of systemic steroids, increased inhaled steroids, beta blockers, MAO inhibitors, or recent asthma exacerbation within 1 month
  • Antibiotic use for respiratory disease within 1 month or respiratory infection within 6 weeks
  • History of asthma-related respiratory failure requiring intubation
  • Positive quantitative skin test reaction to allergen concentration 0.056 BAU or AU/ml
  • Use of beta-adrenergic blockers or monoamine oxidase inhibitors
  • High likelihood of poor compliance
  • Second-hand smoke exposure or indoor furry pets except non-allergic dog with negative skin test
  • Other lung diseases such as sarcoidosis, bronchiectasis, or active lung infection
  • Use of Xolair (omalizumab) within past 6 months
  • Current or past immunotherapy with cat or dust mite extract
  • Non-English speaking
  • History of coagulopathy, thrombocytopenia, pulmonary hypertension, or use of anticoagulants/antiplatelet drugs
  • For healthy controls: history of allergy, asthma, nasal or sinus disease
  • For allergic nonasthmatic subjects: history of asthma or methacholine PC20 less than 16 mg/ml

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

D

Daniel L Hamilos, MD

CONTACT

B

Benjamin D Medoff, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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