NCT01679808

Brief Summary

Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance). Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

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

August 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 3, 2012

Last Update Submit

September 3, 2012

Conditions

Tracheobronchomalacia

Keywords

copdairway obstructionTracheobronchomalacia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (both sexes) in a pulmonary rehabilitation clinic

You may qualify if:

  • copd

You may not qualify if:

  • clinical evidence of malignant disease
  • not able to be subjected to bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glittreklinikken

Hakadal, Akershus, 1485, Norway

Location

MeSH Terms

Conditions

TracheobronchomalaciaPulmonary Disease, Chronic ObstructiveAirway Obstruction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ivar Ellingsen, Dr med

    LHL Helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

August 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2011

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

NO(1)