ClinicalTrials.gov
ClinicalTrials.gov Menu

Markers of Airway Inflammation in BAL Fluid From Children With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838552
Recruitment Status : Enrolling by invitation
First Posted : February 6, 2009
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

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
Asthma

Study Type : Observational
Estimated Enrollment : 40 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 : October 2007
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838552


Locations
United States, Colorado
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

Publications:
Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT00838552     History of Changes
Other Study ID Numbers: NJ HS-2178
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by Jennifer Brandorff, 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