Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients (CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507844
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: positive ventilation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: ventilation Device: positive ventilation
10 minutes of increased 4,7,12 positive pressure ventilation
Other Name: CPAP

Primary Outcome Measures :
  1. improved small airways obstruction [ Time Frame: 2-3 hrs ]
    Following CPAP ventilation measurement be repeated for 3 hrs

Secondary Outcome Measures :
  1. improved respiratory symptoms [ Time Frame: 2-3 hrs ]
    CAT score

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01507844

Pulmonary Institute
Beer Yaakov, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: David stav, MD Assaf-Harofeh Medical Center

Responsible Party: Assaf-Harofeh Medical Center Identifier: NCT01507844     History of Changes
Other Study ID Numbers: 86/09
12 ( Other Identifier: Israel lung Association )
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: November 2011

Keywords provided by Assaf-Harofeh Medical Center:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases