Clinical Study of Intermittent Positive Pressure Breathing (IPPB) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease	Procedure: intermittent positive-pressure breathing	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

November 1976

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	30 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000565

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

More Information

Publications:

National Heart, Lung, and Blood Institute, Division of Lung Diseases: Protocol for Intermittent Positive Pressure Breathing Collaborative Program. Bethesda, Maryland: National Institutes of Health, 1978.

Hodgkin JE and Zorn EG: Intermittent Positive Pressure Breathing (IPPB) in the Outpatient Management of Chronic Obstructive Pulmonary Disease (COPD): Description of the NIH Clinical Trial. Respiratory Care, 26:1095-1104, 1981.

[No authors listed] Intermittent positive pressure breathing therapy of chronic obstructive pulmonary disease. A clinical trial. Ann Intern Med. 1983 Nov;99(5):612-20.

Prigatano GP, Parsons O, Wright E, Levin DC, Hawryluk G. Neuropsychological test performance in mildly hypoxemic patients with chronic obstructive pulmonary disease. J Consult Clin Psychol. 1983 Feb;51(1):108-16. No abstract available.

Vacek JL. Nifedipine and primary pulmonary hypertension. Ann Intern Med. 1984 Mar;100(3):458-9. No abstract available.

Prigatano GP, Wright EC, Levin D. Quality of life and its predictors in patients with mild hypoxemia and chronic obstructive pulmonary disease. Arch Intern Med. 1984 Aug;144(8):1613-9.

Nagai A, West WW, Paul JL, Thurlbeck WM. The National Institutes of Health Intermittent Positive-Pressure Breathing trial: pathology studies. I. Interrelationship between morphologic lesions. Am Rev Respir Dis. 1985 Nov;132(5):937-45.

Nagai A, West WW, Thurlbeck WM. The National Institutes of Health Intermittent Positive-Pressure Breathing trial: pathology studies. II. Correlation between morphologic findings, clinical findings, and evidence of expiratory air-flow obstruction. Am Rev Respir Dis. 1985 Nov;132(5):946-53.

West WW, Nagai A, Hodgkin JE, Thurlbeck WM. The National Institutes of Health Intermittent Positive Pressure Breathing trial--pathology studies. III. The diagnosis of emphysema. Am Rev Respir Dis. 1987 Jan;135(1):123-9.

Wilson DO, Rogers RM, Wright EC, Anthonisen NR. Body weight in chronic obstructive pulmonary disease. The National Institutes of Health Intermittent Positive-Pressure Breathing Trial. Am Rev Respir Dis. 1989 Jun;139(6):1435-8.

Matsuba K, Ikeda T, Nagai A, Thurlbeck WM. The National Institutes of Health Intermittent Positive-Pressure Breathing Trial: pathology studies. IV. The Destructive index. Am Rev Respir Dis. 1989 Jun;139(6):1439-45.

ClinicalTrials.gov Identifier:	NCT00000565 History of Changes
Other Study ID Numbers:	203
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013