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New treatment option for Asthma
Official title Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
ClinicalTrials.gov ID: NCT00595491
What this study is testing
What is Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage?
Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage is an investigational medicine, being studied as a potential treatment for asthma.
Also referred to as One of 3 Standardized allergen extracts will be used:, Standardized Cat Hair Extract.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- A. people with Allergic Asthma (AA people)
- All people will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
- All people will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick...
- 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.
You likely can't join if
- Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception...
- 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...
See the full eligibility criteria
- A. people with Allergic Asthma (AA people)
- All people will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
- All people 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.
- 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.
- people 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...
- Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.
- Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months.
- Immunotherapy with cat or dust mite extract now or in the past.
- Non-English speakers.
- History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs. B. Healthy Normal Control people (NC people) Normal control people will be individuals who are in...
- A history of allergy, asthma, nasal or sinus disease.
- Exclusion criteria #1, 3-8 and 10-19 from (A.) above. C. Allergic Nonasthmatic people (ANA people) Inclusion Criteria:
- ANA people 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...
- All people will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value.
- All people will have a positive allergy skin prick test to cat dander or dust mite allergen.
- All people will be in good general health.
- Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and 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. Exclusion Criteria:
- A history of asthma.
- Exclusion criteria #1, 3-8 and 10-19 from (A.) above.
- A methacholine PC20 \< 16 mg/ml.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.