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

Q: Who can participate in NCT00595491?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT00595491?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Inflammatory Cellular Trafficking in Asthma in Response to Segmental Allergen Challenge

Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation (NCT00595491) is a Phase 1 interventional studying Asthma, sponsored by Benjamin Medoff. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Asthma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 313 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

A. Subjects with Allergic Asthma (AA subjects) Who May Qualify: 1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value. 2. 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). 3. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years). 4. Willing and able to give willing to sign a consent form. 5. Expressed the desire to participate in an interview with the principal investigator. 6. Age between 18 and 50 years. Who Should NOT Join This Trial: 1. 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. 2. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks. 3. Participation in research study involving a drug or biologic during the 30 days prior to the study. 4. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam. 5. Antihistamines within 7 days of the screening visit. 6. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis. 7. 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. 8. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits. 9. A history of asthma-related respiratory failure requiring intubation. 10. Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml . ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

A. Subjects with Allergic Asthma (AA subjects) Inclusion Criteria: 1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value. 2. 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). 3. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years). 4. Willing and able to give informed consent. 5. Expressed the desire to participate in an interview with the principal investigator. 6. Age between 18 and 50 years. Exclusion Criteria: 1. 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. 2. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks. 3. Participation in research study involving a drug or biologic during the 30 days prior to the study. 4. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam. 5. Antihistamines within 7 days of the screening visit. 6. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis. 7. 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. 8. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits. 9. A history of asthma-related respiratory failure requiring intubation. 10. Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml . 11. Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors. 12. Subjects with a high possibility of poor compliance with the study. 13. No history of cigarette smoking within the past 5 years or \> 10 pack years total. 14. 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.) 15. Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection. 16. Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months. 17. Immunotherapy with cat or dust mite extract now or in the past. 18. Non-English speakers. 19. History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs. B. Healthy Normal Control Subjects (NC subjects) Normal control subjects will be individuals who are in good overall health, age and sex matched to the asthmatic group, age 18 - 50 and nonallergic, i.e. entirely negative on the panel of prick skin tests listed in section V (Study Procedures), with no history of allergic rhinitis or asthma, no history of allergic symptoms caused by cats or dust mite allergen exposure, life-long nonsmokers of cigarettes (defined as a lifetime total of less than 5 pack-years and none in 5 years), normal spirometry (i.e. FEV1 and FVC of at least 90% of predicted) and with a methacholine PC20 of \> 16 mg/ml. Exclusion Criteria: 1. A history of allergy, asthma, nasal or sinus disease. 2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above. C. Allergic Nonasthmatic Subjects (ANA subjects) Inclusion Criteria: 1. ANA subjects will have a history of either (a) allergic rhinitis (with one or more of the following symptoms: nasal congestion, sneezing, runny nose, postnasal drainage), (b) allergic conjunctivitis (ocular itching, tearing and/or swelling) or (c) contact allergy associated with cat dander or dust mite and a positive allergy test to the same allergen. 2. All subjects will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value. 3. All subjects will have a positive allergy skin prick test to cat dander or dust mite allergen. 4. All subjects will be in good general health. 5. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and none in 5 years). 6. Willing and able to give informed consent. 7. Expressed the desire to participate in an interview with the principal investigator. 8. Age between 18 and 50 years. Exclusion Criteria: 1. A history of asthma. 2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above. 3. A methacholine PC20 \< 16 mg/ml.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Massachusetts General Hospital

Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT00595491), the sponsor (Benjamin Medoff), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT00595491 clinical trial studying?

Who can participate in NCT00595491?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT00595491?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT00595491. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT00595491. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.