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

NCT00595491 | Recruiting Phase 1 DMC

• 4 other identifiers: 2007-P-001050NIH 4 R37 AI040618BB-IND 13094W81XWH-16-1-0493
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Keywords

Asthma; Inflammation; Allergic; Airway; Challenge; Chemokines

Outcome Measures

Primary Outcomes (1)

• airway inflammation

  1,6, or 24 hours

Study Arms (1)

allergic asthmatic, allergic nonasthmatic, healthy

EXPERIMENTAL

Adults who are allergic asthmatics, allergic nonasthmatics, or healthy controls will receive segmental allergen challenge to the lung

Biological: Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage

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.

Also known as: One of 3 Standardized allergen extracts will be used:, Standardized Cat Hair Extract, Standardized mite extract-Dermatophagoides farinae, Standardized mite extract-Dermatophagoides pteronyssinus, Phenolized saline diluent will also be used in this study., All will be purchased from Greer Laboratories Lenoir,NC.

allergic asthmatic, allergic nonasthmatic, healthy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
• All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick test).
• Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years).
• Willing and able to give informed consent.
• Expressed the desire to participate in an interview with the principal investigator.
• Age between 18 and 50 years.

You may not qualify if:

• Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.
• The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
• Participation in research study involving a drug or biologic during the 30 days prior to the study.
• Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
• Antihistamines within 7 days of the screening visit.
• Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.
• Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
• Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.
• A history of asthma-related respiratory failure requiring intubation.
• Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml .
• Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors.
• Subjects with a high possibility of poor compliance with the study.
• No history of cigarette smoking within the past 5 years or \> 10 pack years total.
• Having second-hand cigarette smoke exposure or indoor furry pets except in the case of dog, if the subject is not allergic to the dog and the subject has a negative skin test to dog (It is also preferred but not required that dust mite allergic subjects have dust mite-proof encasings on their mattress and pillows.)
• Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.

Sponsors & Collaborators

• Benjamin Medoff: lead
• National Institutes of Health (NIH): collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (6)

• Summary and recommendations of a workshop on the investigative use of fiberoptic bronchoscopy and bronchoalveolar lavage in asthmatics. Am Rev Respir Dis. 1985 Jul;132(1):180-2. doi: 10.1164/arrd.1985.132.1.180.

  PMID: 4014864 BACKGROUND

• Busse WW, Lemanske RF Jr. Asthma. N Engl J Med. 2001 Feb 1;344(5):350-62. doi: 10.1056/NEJM200102013440507. No abstract available.

  PMID: 11172168 BACKGROUND

• Djukanovic R, Wilson JW, Lai CK, Holgate ST, Howarth PH. The safety aspects of fiberoptic bronchoscopy, bronchoalveolar lavage, and endobronchial biopsy in asthma. Am Rev Respir Dis. 1991 Apr;143(4 Pt 1):772-7. doi: 10.1164/ajrccm/143.4_Pt_1.772.

  PMID: 2008989 BACKGROUND

• Jarjour NN, Peters SP, Djukanovic R, Calhoun WJ. Investigative use of bronchoscopy in asthma. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):692-7. doi: 10.1164/ajrccm.157.3.9705020.

  PMID: 9517577 BACKGROUND

• Kay AB. Allergy and allergic diseases. Second of two parts. N Engl J Med. 2001 Jan 11;344(2):109-13. doi: 10.1056/NEJM200101113440206. No abstract available.

  PMID: 11150362 BACKGROUND

• Mackay CR. Chemokines: immunology's high impact factors. Nat Immunol. 2001 Feb;2(2):95-101. doi: 10.1038/84298.

  PMID: 11175800 BACKGROUND

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Benjamin D Medoff, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel L Hamilos, MD

CONTACT

617-726-5090; dhamilos@partners.org

Benjamin D Medoff, MD

CONTACT

617-726-6695; bmedoff@partners.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Pulmonary and Critical Care Unit

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)