Markers of Airway Inflammation in BAL Fluid From Children With Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by National Jewish Health
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT00838552
First received: February 4, 2009
Last updated: April 14, 2015
Last verified: April 2015
  Purpose
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
Asthma

Study Type: Observational
Study Design: 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.

Further study details as provided by National Jewish Health:

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 [ Time Frame: Single time point ] [ Designated as safety issue: No ]

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. [ Time Frame: Single time point ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing bronchoscopy at National Jewish Health
Criteria

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
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 ClinicalTrials.gov identifier: NCT00838552

Contacts
Contact: Pia Hauk, MD 303-398-1734 haukp@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Sub-Investigator: Marzena Krawiec, MD         
Sub-Investigator: Elena Goleva, PhD         
Sub-Investigator: Andrew Liu, MD         
Sub-Investigator: Susan Brugman, MD         
Sub-Investigator: Gary Larson, MD         
Sub-Investigator: Carl White, MD         
Sub-Investigator: Donald Leung, MD, PhD         
Sponsors and Collaborators
National Jewish Health
Genentech, Inc.
Investigators
Principal Investigator: Pia Hauk, MD National Jewish Health
  More Information

Publications:
Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT00838552     History of Changes
Other Study ID Numbers: NJ HS-2178 
Study First Received: February 4, 2009
Last Updated: April 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
asthma inflammation bronchoscopy

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 27, 2016