Completed
Evaluation of Asthma Molecular Mechanisms through Sample Collection
Study Aim
This observational study aims to assess the role of apolipoprotein and lipid pathways in asthmatic and non-asthmatic individuals, potentially identifying new therapeutic targets for asthmatic airway inflammation.
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Bronchial Diseases+6
+ Hypersensitivity
+ Hypersensitivity, Immediate
From 18 to 75 Years
+11 Eligibility Criteria
How is the trial designed
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Observational
Study Start: June 1999
Summary
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 2, 1999
Actual date on which the first participant was enrolled.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.
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
574 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma
Criteria
7 inclusion criteria required to participate
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
For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction
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
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
Show More Criteria
4 exclusion criteria prevent from participating
Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation)
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) or hepatitis virus
Same as the asthmatic exclusion criteria plus a history of asthma
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google MapsCompletedOne Study Center