COMPLETED

Sample Collections From the Airways of Asthmatic Patients

Conditions

Asthma Induced Sputum Exhaled Breath Condensate Fiberoptic Bronchoscopy Bronchoscopy mRNA Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Asthma Sample Collection Protocol

Quick Facts

Study Start:1999-06-02

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT00001888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients undergoing a research bronchoscopy 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 demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV1 of at least 20% at a PD20 dose \< 200 microgram. Reversible airway obstruction will be defined as an improvement of at least 10% in either the FEV1 or FVC following bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of reversible airflow obstruction. 2. For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to 3. Asthmatic research subjects who will only be providing research blood specimens, nasal epithelial lining fluid, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens, or other non-invasive samples, such as nasal epithelial lining fluid, sputum, or exhaled breath condensate.	1. Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female. 2. A negative inhalational methacholine challenge as defined by the absence of a 20% decrease in FEV1 at a PD20 dose of \> 400 microgram (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of a negative methacholine challenge. 3. For women of childbearing potential, negative pregnancy test within 2 weeks prior to bronchoscopy and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction. 4. Research volunteers who will only be providing research blood specimens, nasal epithelial lining fluid, sputum, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age.

Inclusion Criteria

Exclusion Criteria

1. Patients undergoing a research bronchoscopy 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 demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV1 of at least 20% at a PD20 dose \< 200 microgram. Reversible airway obstruction will be defined as an improvement of at least 10% in either the FEV1 or FVC following bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of reversible airflow obstruction.
2. For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to
3. Asthmatic research subjects who will only be providing research blood specimens, nasal epithelial lining fluid, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens, or other non-invasive samples, such as nasal epithelial lining fluid, sputum, or exhaled breath condensate.

1. Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female.
2. A negative inhalational methacholine challenge as defined by the absence of a 20% decrease in FEV1 at a PD20 dose of \> 400 microgram (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of a negative methacholine challenge.
3. For women of childbearing potential, negative pregnancy test within 2 weeks prior to bronchoscopy and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction.
4. Research volunteers who will only be providing research blood specimens, nasal epithelial lining fluid, sputum, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age.

Contacts and Locations

Principal Investigator

Amisha V Barochia, M.D.

PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Amisha V Barochia, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1999-06-02

Study Completion DateN/A

Study Record Updates

Study Start Date1999-06-02

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

Induced Sputum
Exhaled Breath Condensate
Fiberoptic Bronchoscopy
Bronchoscopy
mRNA
Natural History

Additional Relevant MeSH Terms

Asthma