NCT00536315

Brief Summary

The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 1999

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

March 1, 1999

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 10, 2017

Status Verified

February 1, 2010

Enrollment Period

9.3 years

First QC Date

September 26, 2007

Last Update Submit

March 8, 2017

Conditions

TracheomalaciaTracheobronchomalacia

Keywords

COPD

Study Arms (3)

COPD

Patients with cough and/or shortness of breath who may have windpipe collapse.

Healthy adults

Subjects without symptoms for comparison.

Tracheomalacia

Patients with cough and/or shortness of breath who may have windpipe collapse.

Eligibility Criteria

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

Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.

You may qualify if:

  • Suspicion of tracheal collapse undergoing bronchoscopy
  • Healthy control subject undergoing bronchoscopy for another purpose.

You may not qualify if:

  • Esophageal pathology
  • Tracheostomy
  • inability to follow commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24. doi: 10.1378/chest.06-2556.

    PMID: 17426218RESULT

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

  • Stephen H Loring, M.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anaesthesia

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

March 1, 1999

Primary Completion

July 1, 2008

Study Completion

June 1, 2009

Last Updated

March 10, 2017

Record last verified: 2010-02

Locations

US(1)