AsthmaNCT00838552
Markers of Airway Inflammation in BAL Fluid From Children With Asthma
An observational study of Asthma, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Asthma
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 21 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients undergoing bronchoscopy at National Jewish Health
Who may be able to join
- 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].
Who cannot join
- Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Keywords
- asthma inflammation bronchoscopy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startOct 2007
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Pia Hauk, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838552
- Sponsor's protocol ID
- NJ HS-2178
- Status last verified
- Oct 2020
- First submitted
- 4 Feb 2009
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 2461667Bousquet 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.
PubMed 2215562Vignola 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.
PubMed 10200002Woodman 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.
PubMed 16899834Krawiec 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.
PubMed 11371398
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Markers of Airway Inflammation and Remodeling in Bronchoalveolar Lavage Fluid From Children With Asthma.
- ClinicalTrials.gov ID
- NCT00838552
- Acronym / sponsor ID
- NJ HS-2178
- Conditions
- Asthma
- Keywords
- asthma inflammation bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2007
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing bronchoscopy at National Jewish Health
Key inclusion criteria (3 listed)
- 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].
Key exclusion criteria (1 listed)
- Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 2461667Wenzel 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.
- Background: PubMed 2215562Bousquet 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.
- Background: PubMed 10200002Vignola 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.
- Background: PubMed 16899834Woodman 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.
- Background: PubMed 11371398Krawiec 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Hauk, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838552, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.