Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00705848

Purpose

It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small pieces of tissue) and brushings (to collect the cells that form the lining of the airway) from the airways of patients with these diseases and analyze these samples in a laboratory to try and determine the mechanism of disease. We will compare the results with that of patients with normal airways.

Condition
Tracheobronchomalacia Tracheal Stenosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Airway biopsies and brushings are to be used for staining and culture, respectively

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 10 patients with tracheobronchomalacia
2 10 patients with tracheal stenosis
3 10 patients with normal airways (no known airway diseases)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients with tracheobronchomalacia or tracheal stenosis referred to this tertiary care facility

Criteria

Inclusion Criteria:

(study group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.
(control group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.

Exclusion Criteria:

(study group): pre-existing airway disorders other than tracheobronchomalacia or subglottic stenosis, etiology of subglottic stenosis other than idiopathic or post-intubation, pulmonary vascular disease, inability to tolerate intravenous conscious sedation.
(control group): any pre-existing airway disorder, pulmonary vascular disease, and inability to tolerate intravenous conscious sedation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705848

Contacts

Contact: Dilip Nataraj, M.D.	617-632-8353	dnataraj@bidmc.harvard.edu
Contact: Armin Ernst, M.D.	617-632-8353	aernst@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Armin Ernst, M.D.
Sub-Investigator: Dilip Nataraj, M.D.
Sub-Investigator: Adnan Majid, M.D.
Sub-Investigator: Raghu Kalluri, M.D.

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Armin Ernst, M.D.

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Beth Israel Deaconess Medical Center ( Armin Ernst M.D. )
Study ID Numbers:	2007P-000336
Study First Received:	June 24, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00705848
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

trachea
malacia
stenosis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Respiratory Tract Diseases
Tracheal Stenosis
Tracheobronchomalacia
Constriction, Pathologic

Additional relevant MeSH terms:

Tracheal Diseases

ClinicalTrials.gov processed this record on January 16, 2009