Tracheobronchomalacia: Treatment Outcomes

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Tracheobronchomalacia
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Brief Title

Tracheobronchomalacia: Treatment Outcomes

Official Title

Tracheobronchomalacia: Treatment Outcomes

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 Type

Observational

Primary Outcome

To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.

Secondary Outcome

 To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.

Condition

Tracheomalacia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

150

Start Date

January 2002

Completion Date

March 2010

Primary Completion Date

March 2010

Eligibility 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

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Armin Ernst, M.D. FCCP, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00550602

Organization ID

2005P000112

Study Sponsor

Beth Israel Deaconess Medical Center

Study Sponsor

Armin Ernst, M.D. FCCP, Principal Investigator, Beth Israel Deaconess Medical Center

Verification Date

April 2010