Tracheobronchomalacia: Treatment Outcomes

Tracheobronchomalacia Clinical Trial

Official title:

Tracheobronchomalacia: Treatment Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550602
• Other study ID #: 2005P000112
• Status: Completed
• Phase: N/A
• First received: October 26, 2007
• Last updated: February 2, 2017
• Start date: January 2002
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheobronchomalacia
• Tracheomalacia

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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