Tracheobronchomalacia: Treatment Outcomes

Completed

• Conditions: Tracheomalacia; Tracheobronchomalacia

• Registration Number: NCT00550602
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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).

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 Timeline

• Study Start: 2002-01
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-30
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.	At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.	At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology; 🇺🇸 Boston, Massachusetts, United States