NCT00550602

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 3, 2017

Status Verified

April 1, 2010

Enrollment Period

8.2 years

First QC Date

October 26, 2007

Last Update Submit

February 2, 2017

Conditions

TracheomalaciaTracheobronchomalacia

Keywords

TracheomalaciaTracheobronchomalaciaAirway StabilizationBronchoscopyStent PlacementTracheobronchoplastyCOPD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • inability to follow commands
  • Focal extrinsic compression of the trachea/bronchi by mass or other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

  • 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.

    PMID: 17699133RESULT

  • 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.

    PMID: 21868463DERIVED

  • 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.

    PMID: 21493699DERIVED

  • 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.

    PMID: 18842912DERIVED

MeSH Terms

Conditions

TracheomalaciaTracheobronchomalaciaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesTracheal DiseasesRespiratory Tract DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Armin Ernst, M.D. FCCP

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2007

First Posted

October 30, 2007

Study Start

January 1, 2002

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 3, 2017

Record last verified: 2010-04

Locations

US(1)