Markers of Airway Inflammation in BAL Fluid From Children With Asthma
Sponsor
National Jewish Health (Other)
Overall Status
Completed
CT.gov ID
NCT00838552
Collaborator
Genentech, Inc. (Industry)
103
1
128.7
0.8
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
103 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Prospective Analysis of Markers of Airway Inflammation and Remodeling in Bronchoalveolar Lavage Fluid From Children With Asthma.
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Jun 21, 2018
Actual Study Completion Date
:
Jun 21, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Asthma subjects Children with asthma undergoing clinically indicated bronchoscopy at National Jewish Health. |
|
| 2 Non-asthma subjects Children with other respiratory diseases than asthma undergoing clinically indicated bronchoscopy at National Jewish Health. |
Outcome Measures
Primary Outcome Measures
- 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 [Single time point]
Secondary Outcome Measures
- 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. [Single time point]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Jewish Health | Denver | Colorado | United States | 80206 |
Sponsors and Collaborators
- National Jewish Health
- Genentech, Inc.
Investigators
- Principal Investigator: Pia Hauk, MD, National Jewish Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Bousquet J, Chanez P, Lacoste JY, Barnéon 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00838552
Other Study ID Numbers:
- NJ HS-2178
First Posted:
Feb 6, 2009
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Keywords provided by National Jewish Health
Additional relevant MeSH terms: