Sample Collections From the Airways of Asthmatic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001888
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: August 2013
  Purpose

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.


Condition
Asthma
Healthy

Study Type: Observational
Official Title: Fiberoptic Bronchoscopy in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: March 1999
Detailed Description:

This tissue procurement protocol proposes to perform fiberoptic bronchoscopy with bronchoalveolar lavage, bronchial brushings exhaled brath condensates, and bronchial wall biopsies to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation and remodeling in asthmatic patients. The objective of this protocol is to assess the expression, regulation, and function of proteins regulating the release of soluble receptors and mediators from asthmatic inflammatory and structural cell populations, with a focus on the role of exosome-associated proteins and receptors in the regulation of airway inflammatory responses.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

ASTHMATICS:

Patients will be between 18 and 75 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).

Post-bronchodilator FEV1 < 40% of predicted or pre-bronchodilator FEV1 < 35% 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 75 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001888

Contacts
Contact: Maryann M Kaler, C.R.N.P. (301) 451-5916 mk371e@nih.gov
Contact: Stewart J Levine, M.D. (301) 402-1553 levines@nhlbi.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Stewart J Levine, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001888     History of Changes
Other Study ID Numbers: 990076, 99-H-0076
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Airway Inflammation
Bronchial Brushing
Bronchial Wall Biopsy
Bronchoalveolar Lavage
Tissue Procurement
Asthma
Normal Volunteer

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014