Tracheobronchomalacia: Treatment Outcomes - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00550602

Purpose

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).

Condition
Tracheomalacia Tracheobronchomalacia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Tracheobronchomalacia: Treatment Outcomes

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2010

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550602

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Arthur Dea 617-632-8353 adea@caregroup.harvard.edu
Contact: Adnan Majid, M.D. 617-632-8252 amajid@bidmc.harvard.edu
Principal Investigator: Armin Ernst, M.D. FCCP

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Armin Ernst, M.D. FCCP

Beth Israel Deaconess Medical Center

More Information

Publications of Results:

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.

Publications indexed to this study:

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):801-7.

Study ID Numbers:	2005P-000112
Study First Received:	October 26, 2007
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00550602
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Tracheomalacia
Tracheobronchomalacia
Airway Stabilization
Bronchoscopy

Stent Placement
Tracheobronchoplasty
COPD

Study placed in the following topic categories:

Tracheobronchomalacia

ClinicalTrials.gov processed this record on January 15, 2009