NIH Clinical Research Studies

Protocol Number: 99-H-0076

Active Accrual, Protocols Recruiting New Patients

Title:
Fiberoptic Bronchoscopy in Patients with Asthma
Number:
99-H-0076
Summary:
Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells.

In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.

Sponsoring Institute:
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

ASTHMATICS:

Patients will be between 18 and 65 years of age, male or female.

The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation.

Patients will be between 18 and 65 years of age, male or female. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. In addition, patients will have either an abnormal methacholine challenge or evidence of ongoing reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV(1) of at least 20% following inhalation of less than or equal to 4 mg/ml of methacholine. Ongoing reversible airway obstruction will be defined as an improvement of at least 12% and 200 cc in either the FEV(1) or FVC folowing bronchodilator treatment.

For women of childbearing potential, negative pregnancy test prior to study and willingness to adhere to reliable birth control methods during the study.

EXCLUSION CRITERIA:

ASTHMATICS:

Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).

Respiratory tract infection or asthma exacerbation within 4 weeks of screening.

History of adverse reactions to lidocaine or other local anesthetics.

Allergy to methacholine.

Use of aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study.

History of cigarette smoking within the past 3 months.

History of drug or alcohol abuse.

Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation).

Severe asthma as defined by a FEV(1) less than 60 percent of predicted.

Active bronchospasm on physical examination.

History of lidocaine allergy.

History of prior cardiac disease.

For Bronchial Biopsies: PT and PTT greater than ULN.

For Bronchial Brushings or BAL:

-PT greater than 1 second above ULN or INR greater than 1.3.

-PTT greater than 1 second above ULN.

Platelet less than 150,00/ml.

Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.

Serum Creatine greater than 2.0.

Liver function tests greater than 2 times upper limit of normal.

Any condition that, in the investigator's opinion, places the patient at undue risk for complications from fiberoptic bronchoscopy, bronchalveolar lavage, bronchial brushings, or bronchial biopsies.

INCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Research volunteers will be between 18 and 65 years of age, male or female.

A negative inhalational methacholine challenge as defined bv the absence of a 20% decrease in FEV, following inhalation of 16 mg/ml of methacholine.

For women of childbearing potential, negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.

EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Same as the asthmatic exclusion criteria plus a history of asthma.

Special Instructions:
Currently Not Provided
Keywords:
Airway Inflammation
Bronchial Brushing
Bronchial Wall Biopsy
Bronchoalveolar Lavage
Tissue Procurement
Recruitment Keyword(s):
Asthma
Normal Volunteer
Condition(s):
Asthma
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Heart, Lung and Blood Institute

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Identification of activated T lymphocytes and eosinophils in bronchial biopsies in stable atopic asthma

Immunohistochemical characterization of the cellular infiltration in asthmatic bronchi

Airway mucosal inflammation even in patients with newly diagnosed asthma

Active Accrual, Protocols Recruiting New Patients

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