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Sample Collections From the Airways of Asthmatic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 8, 2017 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier:
First received: November 3, 1999
Last updated: May 10, 2017
Last verified: May 8, 2017

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.


Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Asthma Sample Collection Protocol

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

Estimated Enrollment: 99999999
Study Start Date: March 30, 1999
Detailed Description:
This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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.



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 or electronic cigarette smoking within the past 3 months.

History of drug or alcohol abuse within the past year.

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 INR greater than or equal to 1.3.
  • PTT greater than 5 seconds 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.


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.


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 identifier: NCT00001888

Contact: Maryann M Kaler, C.R.N.P. (301) 451-5916
Contact: Stewart J Levine, M.D. (301) 402-1553

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   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stewart J Levine, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00001888     History of Changes
Other Study ID Numbers: 990076
Study First Received: November 3, 1999
Last Updated: May 10, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Induced Sputum
Exhaled Breath Condensate
Fiberoptic Bronchoscopy
Normal Volunteer

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 24, 2017