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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01507844
First received: November 2, 2009
Last updated: January 8, 2012
Last verified: November 2011
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Device: positive ventilation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • improved small airways obstruction [ Time Frame: 2-3 hrs ] [ Designated as safety issue: No ]
    Following CPAP ventilation measurement be repeated for 3 hrs


Secondary Outcome Measures:
  • improved respiratory symptoms [ Time Frame: 2-3 hrs ] [ Designated as safety issue: No ]
    CAT score


Enrollment: 24
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: ventilation Device: positive ventilation
10 minutes of increased 4,7,12 positive pressure ventilation
Other Name: CPAP

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • active ischemic heart disease
  • heart failure
  • peripheral vascular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507844

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

No publications provided

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01507844     History of Changes
Other Study ID Numbers: 86/09, 12
Study First Received: November 2, 2009
Last Updated: January 8, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
COPD
CPAP
Sham
FEV1
IC
RV/TLC

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

ClinicalTrials.gov processed this record on August 27, 2014