NCT01507844

Brief Summary

Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

November 2, 2009

Last Update Submit

January 8, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDCPAPShamFEV1ICRV/TLC

Outcome Measures

Primary Outcomes (1)

  • improved small airways obstruction

    Following CPAP ventilation measurement be repeated for 3 hrs

    2-3 hrs

Secondary Outcomes (1)

  • improved respiratory symptoms

    2-3 hrs

Study Arms (1)

ventilation

SHAM COMPARATOR
Device: positive ventilation

Interventions

positive ventilationDEVICE

10 minutes of increased 4,7,12 positive pressure ventilation

Also known as: CPAP
ventilation

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive lung disease stage 2-3 GOLD
  • FRC \> 120%

You may not qualify if:

  • active ischemic heart disease
  • heart failure
  • peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Institute

Beer Yaakov, 70300, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David stav, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2009

First Posted

January 11, 2012

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

January 11, 2012

Record last verified: 2011-11

Locations

IL(1)