Clinical Study of Intermittent Positive Pressure Breathing (IPPB)

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ClinicalTrials.gov Identifier: NCT00000565

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : April 14, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease	Procedure: intermittent positive-pressure breathing	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Primary Purpose:	Treatment
Study Start Date :	November 1976

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00000565

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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OverallOfficial:	Nicholas Anthonisen	University of Manitoba
OverallOfficial:	John Hodgkin	Loma Linda University Medical Center
OverallOfficial:	Philip Hopewell	San Francisco General Hospital
OverallOfficial:	David Levin	University of Oklahoma
OverallOfficial:	Paul Stevens	Baylor College of Medicine
OverallOfficial:	Elizabeth Wright	George Washington University

More Information

Study Data/Documents: Individual Participant Data Set This link exits the ClinicalTrials.gov site

Identifier: IPPB
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Study Protocol This link exits the ClinicalTrials.gov site

Study Forms This link exits the ClinicalTrials.gov site

Manual of Procedures This link exits the ClinicalTrials.gov site

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.

Intermittent positive pressure breathing therapy of chronic obstructive pulmonary disease. A clinical trial. Ann Intern Med. 1983 Nov;99(5):612-20. doi: 10.7326/0003-4819-99-5-612.

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. doi: 10.1037//0022-006x.51.1.108. 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. doi: 10.1164/arrd.1985.132.5.937.

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. doi: 10.1164/arrd.1985.132.5.946.

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. doi: 10.1164/arrd.1987.135.1.123.

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. doi: 10.1164/ajrccm/139.6.1435.

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. doi: 10.1164/ajrccm/139.6.1439.

Intermittent Positive Pressure Breathing Trial Group. (Letter). Ann Intern Med, 100:458, 1984.

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ClinicalTrials.gov Identifier:	NCT00000565
Other Study ID Numbers:	203
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	April 14, 2016
Last Verified:	May 2002

Additional relevant MeSH terms:

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

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