- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838552
Markers of Airway Inflammation in BAL Fluid From Children With Asthma
October 19, 2020 updated by: National Jewish Health
Prospective Analysis of Markers of Airway Inflammation and Remodeling in Bronchoalveolar Lavage Fluid From Children With Asthma.
The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic children to those markers found in non-asthmatic children with other respiratory diseases.
The investigators hypothesize that certain markers will be associated specifically with asthma.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health
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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.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing bronchoscopy at National Jewish Health
Description
Inclusion Criteria:
- 18 years of age or younger
- Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection.
- Consent and assent from parent and patient [if appropriate].
Exclusion Criteria:
- Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1 Asthma subjects
Children with asthma undergoing clinically indicated bronchoscopy at National Jewish Health.
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2 Non-asthma subjects
Children with other respiratory diseases than asthma undergoing clinically indicated bronchoscopy at National Jewish Health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The measurement of levels of lipopolysaccharides [LPS], which mediates airway inflammation, in bronchoalveolar lavage [BAL] fluid from children with asthma and comparison to LPS levels in children with non-asthma respiratory diseases
Time Frame: Single time point
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Single time point
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterization of the inflammatory cytokine and chemokine profiles in bronchoalveolar lavage [BAL] fluid in children with asthma and comparison to the profile for children with non-asthma respiratory diseases.
Time Frame: Single time point
|
Single time point
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wenzel SE, Fowler AA 3rd, Schwartz LB. Activation of pulmonary mast cells by bronchoalveolar allergen challenge. In vivo release of histamine and tryptase in atopic subjects with and without asthma. Am Rev Respir Dis. 1988 May;137(5):1002-8. doi: 10.1164/ajrccm/137.5.1002.
- Bousquet J, Chanez P, Lacoste JY, Barneon G, Ghavanian N, Enander I, Venge P, Ahlstedt S, Simony-Lafontaine J, Godard P, et al. Eosinophilic inflammation in asthma. N Engl J Med. 1990 Oct 11;323(15):1033-9. doi: 10.1056/NEJM199010113231505.
- Vignola AM, Chanez P, Chiappara G, Siena L, Merendino A, Reina C, Gagliardo R, Profita M, Bousquet J, Bonsignore G. Evaluation of apoptosis of eosinophils, macrophages, and T lymphocytes in mucosal biopsy specimens of patients with asthma and chronic bronchitis. J Allergy Clin Immunol. 1999 Apr;103(4):563-73. doi: 10.1016/s0091-6749(99)70225-3.
- Woodman L, Sutcliffe A, Kaur D, Berry M, Bradding P, Pavord ID, Brightling CE. Chemokine concentrations and mast cell chemotactic activity in BAL fluid in patients with eosinophilic bronchitis and asthma, and in normal control subjects. Chest. 2006 Aug;130(2):371-8. doi: 10.1378/chest.130.2.371.
- Krawiec ME, Westcott JY, Chu HW, Balzar S, Trudeau JB, Schwartz LB, Wenzel SE. Persistent wheezing in very young children is associated with lower respiratory inflammation. Am J Respir Crit Care Med. 2001 May;163(6):1338-43. doi: 10.1164/ajrccm.163.6.2005116.
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 Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
June 21, 2018
Study Completion (Actual)
June 21, 2018
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 5, 2009
First Posted (Estimate)
February 6, 2009
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJ HS-2178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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