RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage for Asthma

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.

Official registry: https://clinicaltrials.gov/study/NCT00595491 · Benjamin Medoff · enrollment listed as 313

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage. The registry lists allocation as na. Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction.

They plan to enroll about 313 people at Boston. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Inflammatory Cellular Trafficking in Asthma in Response to Segmental Allergen Challenge

Interventions: Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage

Primary outcome (registry wording): airway inflammation

Who it is for (from inclusion criteria)

Ages 18 Years to 50 Years
A. Subjects with Allergic Asthma (AA subjects)
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)
Expressed the desire to participate in an interview with the principal investigator
Age between 18 and 50 years

Who the registry excludes

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

Public study contact (from the registry)

Daniel L Hamilos, MD

617-726-5090

dhamilos@partners.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Massachusetts General Hospital — Boston, Massachusetts (recruiting)

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FAQ about this NCT record

Is NCT00595491 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT00595491?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT00595491?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary