Tracheobronchomalacia: Treatment Outcomes

NCT ID: NCT00550602

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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

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Tracheomalacia Tracheobronchomalacia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* inability to follow commands
* Focal extrinsic compression of the trachea/bronchi by mass or other
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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BIDMC

Principal Investigators

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Armin Ernst, M.D. FCCP

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17699133 (View on PubMed)

Ernst 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.

Reference Type DERIVED
PMID: 21868463 (View on PubMed)

Odell 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.

Reference Type DERIVED
PMID: 21493699 (View on PubMed)

Majid 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.

Reference Type DERIVED
PMID: 18842912 (View on PubMed)

Other Identifiers

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2005P000112

Identifier Type: -

Identifier Source: org_study_id

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