TracheomalaciaNCT00550602
Tracheobronchomalacia: Treatment Outcomes
An observational study of Tracheomalacia and Tracheobronchomalacia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tracheomalacia, Tracheobronchomalacia
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.
Who may be able to join
- Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study.
- Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse
Who cannot join
- inability to follow commands
- Focal extrinsic compression of the trachea/bronchi by mass or other
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology
Boston, Massachusetts, 02215
About this study
The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).
Read the detailed description
TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.
Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.
- Conditions
- Tracheomalacia, Tracheobronchomalacia
- Keywords
- Tracheomalacia, Tracheobronchomalacia, Airway Stabilization, Bronchoscopy, Stent Placement, Tracheobronchoplasty, COPD
- Medical subject headings
- Tracheomalacia, Tracheobronchomalacia, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
Measured: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
Secondary outcomes (1)
To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.
Measured: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJan 2002
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TracheomalaciaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Armin Ernst, M.D. FCCP, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550602
- Sponsor's protocol ID
- 2005P000112
- Status last verified
- Apr 2010
- First submitted
- 26 Oct 2007
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ernst A, Majid A, Feller-Kopman D, Guerrero J, Boiselle P, Loring SH, O'Donnell C, Decamp M, Herth FJ, Gangadharan S, Ashiku S. Airway stabilization with silicone stents for treating adult tracheobronchomalacia: a prospective observational study. Chest. 2007 Aug;132(2):609-16. doi: 10.1378/chest.06-2708.
PubMed 17699133Ernst A, Odell DD, Michaud G, Majid A, Herth FFJ, Gangadharan SP. Central airway stabilization for tracheobronchomalacia improves quality of life in patients with COPD. Chest. 2011 Nov;140(5):1162-1168. doi: 10.1378/chest.10-3051. Epub 2011 Aug 25.
PubMed 21868463Odell DD, Shah A, Gangadharan SP, Majid A, Michaud G, Herth F, Ernst A. Airway stenting and tracheobronchoplasty improve respiratory symptoms in Mounier-Kuhn syndrome. Chest. 2011 Oct;140(4):867-873. doi: 10.1378/chest.10-2010. Epub 2011 Apr 14.
PubMed 21493699Majid A, Guerrero J, Gangadharan S, Feller-Kopman D, Boiselle P, DeCamp M, Ashiku S, Michaud G, Herth F, Ernst A. Tracheobronchoplasty for severe tracheobronchomalacia: a prospective outcome analysis. Chest. 2008 Oct;134(4):801-807. doi: 10.1378/chest.08-0728.
PubMed 18842912
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheobronchomalacia: Treatment Outcomes
- ClinicalTrials.gov ID
- NCT00550602
- Acronym / sponsor ID
- 2005P000112
- Conditions
- Tracheomalacia, Tracheobronchomalacia
- Keywords
- Tracheomalacia, Tracheobronchomalacia, Airway Stabilization, Bronchoscopy, Stent Placement, Tracheobronchoplasty, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Oct 2007 (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 purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).
Detailed description
TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.
Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.
Key inclusion criteria (2 listed)
- Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study.
- Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse
Key exclusion criteria (2 listed)
- inability to follow commands
- Focal extrinsic compression of the trachea/bronchi by mass or other
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
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
Time frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
1 secondary outcome
To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.
Time frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
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 3 Feb 2017.
- Results publication: PubMed 17699133Ernst A, Majid A, Feller-Kopman D, Guerrero J, Boiselle P, Loring SH, O'Donnell C, Decamp M, Herth FJ, Gangadharan S, Ashiku S. Airway stabilization with silicone stents for treating adult tracheobronchomalacia: a prospective observational study. Chest. 2007 Aug;132(2):609-16. doi: 10.1378/chest.06-2708.
- Derived from this study: PubMed 21868463Ernst A, Odell DD, Michaud G, Majid A, Herth FFJ, Gangadharan SP. Central airway stabilization for tracheobronchomalacia improves quality of life in patients with COPD. Chest. 2011 Nov;140(5):1162-1168. doi: 10.1378/chest.10-3051. Epub 2011 Aug 25.
- Derived from this study: PubMed 21493699Odell DD, Shah A, Gangadharan SP, Majid A, Michaud G, Herth F, Ernst A. Airway stenting and tracheobronchoplasty improve respiratory symptoms in Mounier-Kuhn syndrome. Chest. 2011 Oct;140(4):867-873. doi: 10.1378/chest.10-2010. Epub 2011 Apr 14.
- Derived from this study: PubMed 18842912Majid A, Guerrero J, Gangadharan S, Feller-Kopman D, Boiselle P, DeCamp M, Ashiku S, Michaud G, Herth F, Ernst A. Tracheobronchoplasty for severe tracheobronchomalacia: a prospective outcome analysis. Chest. 2008 Oct;134(4):801-807. doi: 10.1378/chest.08-0728.
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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.
Armin Ernst, M.D. FCCP principal investigator
Beth Israel Deaconess Medical Center
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 Tracheomalacia and Tracheobronchomalacia, run by Beth Israel Deaconess Medical Center 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 2 inclusion and 2 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 3 Feb 2017. 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?
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia. (time frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty). 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 NCT00550602, which also lists 4 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 3 Feb 2017.