Back to resultsContinuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients (CPAP)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
positive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, CPAP, Sham, FEV1, IC, RV/TLC
Eligibility Criteria
Inclusion Criteria:
- chronic obstructive lung disease stage 2-3 GOLD
- FRC > 120%
Exclusion Criteria:
- active ischemic heart disease
- heart failure
- peripheral vascular disease
Sites / Locations
- Pulmonary Institute
Arms of the Study
Arm 1
Arm Type
Sham Comparator
Arm Label
ventilation
Arm Description
Outcomes
Primary Outcome Measures
improved small airways obstruction
Following CPAP ventilation measurement be repeated for 3 hrs
Secondary Outcome Measures
improved respiratory symptoms
CAT score
Full Information
NCT ID
NCT01507844
First Posted
November 2, 2009
Last Updated
January 8, 2012
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01507844
Brief Title
Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients
Acronym
CPAP
Official Title
Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, CPAP, Sham, FEV1, IC, RV/TLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
positive ventilation
Other Intervention Name(s)
CPAP
Intervention Description
10 minutes of increased 4,7,12 positive pressure ventilation
Primary Outcome Measure Information:
Title
improved small airways obstruction
Description
Following CPAP ventilation measurement be repeated for 3 hrs
Time Frame
2-3 hrs
Secondary Outcome Measure Information:
Title
improved respiratory symptoms
Description
CAT score
Time Frame
2-3 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic obstructive lung disease stage 2-3 GOLD
FRC > 120%
Exclusion Criteria:
active ischemic heart disease
heart failure
peripheral vascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David stav, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Institute
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
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Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients
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