NCT00838552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

10.7 years

First QC Date

February 4, 2009

Last Update Submit

October 19, 2020

Conditions

Keywords

asthma inflammation bronchoscopy

Outcome Measures

Primary Outcomes (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

    Single time point

Secondary Outcomes (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.

    Single time point

Study Arms (2)

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 Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing bronchoscopy at National Jewish Health

You may qualify if:

  • 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 \[if appropriate\].

You may not qualify if:

  • Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (5)

  • 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.

    PMID: 2461667BACKGROUND
  • 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.

    PMID: 2215562BACKGROUND
  • 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.

    PMID: 10200002BACKGROUND
  • 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.

    PMID: 16899834BACKGROUND
  • 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.

    PMID: 11371398BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Pia Hauk, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 6, 2009

Study Start

October 1, 2007

Primary Completion

June 21, 2018

Study Completion

June 21, 2018

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations