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Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
This study has been completed.
Study NCT00000565   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: October 27, 1999   Last Updated: June 23, 2005   History of Changes

October 27, 1999
June 23, 2005
November 1976
 
 
 
Complete list of historical versions of study NCT00000565 on ClinicalTrials.gov Archive Site
 
 
 
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
 

To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB) treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered nebulizer.

BACKGROUND:

Intermittent positive pressure breathing may be a useful adjunct therapy for patients with chronic obstructive pulmonary disease. It is, however, quite expensive; moreover, in 1976 its treatment efficacy had not been determined. Although the effectiveness of IPPB had been previously studied, the influence of long-term treatment was not known for the following reasons: The individuals studied had been too few and were not randomly assigned to treatment groups, the patient groups were not homogeneous and their clinical and functional status were not well-documented, and precise descriptions of the manner in which IPPB was administered were not recorded.

Based on these facts, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, issued a recommendation to develop a controlled clinical study of IPPB. Contracts were awarded to five clinical centers and a data center in November 1976. Planning of the trial ended in November 1977. Recruitment began in April 1978 for the 985 individuals who took part in this trial and ended in October 1980. Patients enrolled after March 31, 1980, were followed for 30 months instead of 36 months. Follow-up was completed in May 1983.

DESIGN NARRATIVE:

Randomized, fixed sample of 985 patients. Eligible patients were assigned to a treatment group using intermittent positive pressure breathing or to a control group using a powered nebulizer for treatment 3-4 times a day. Treatments continued for 3 years. Endpoints related to quality of life and respiratory function and capability.

Phase III
Interventional
Treatment, Randomized
  • Lung Diseases
  • Lung Diseases, Obstructive
  • Chronic Obstructive Pulmonary Disease
Procedure: intermittent positive-pressure breathing
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.

Both
30 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00000565
 
203
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Nicholas Anthonisen University of Manitoba
Investigator: John Hodgkin Loma Linda University Medical Center
Investigator: Philip Hopewell San Francisco General Hospital
Investigator: David Levin University of Oklahoma
Investigator: Paul Stevens Baylor College of Medicine
Investigator: Elizabeth Wright George Washington University
National Heart, Lung, and Blood Institute (NHLBI)
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP