Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
Primary Purpose
Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
intermittent positive-pressure breathing
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases
Eligibility Criteria
Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000565
First Posted
October 27, 1999
Last Updated
April 13, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000565
Brief Title
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
November 1976 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
intermittent positive-pressure breathing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Anthonisen
Organizational Affiliation
University of Manitoba
First Name & Middle Initial & Last Name & Degree
John Hodgkin
Organizational Affiliation
Loma Linda University Medical Center
First Name & Middle Initial & Last Name & Degree
Philip Hopewell
Organizational Affiliation
San Francisco General Hospital
First Name & Middle Initial & Last Name & Degree
David Levin
Organizational Affiliation
University of Oklahoma
First Name & Middle Initial & Last Name & Degree
Paul Stevens
Organizational Affiliation
Baylor College of Medicine
First Name & Middle Initial & Last Name & Degree
Elizabeth Wright
Organizational Affiliation
George Washington University
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
6357018
Citation
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.
Results Reference
background
PubMed Identifier
6826857
Citation
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.
Results Reference
background
PubMed Identifier
6380440
Citation
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.
Results Reference
background
PubMed Identifier
3904548
Citation
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.
Results Reference
background
PubMed Identifier
3904549
Citation
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.
Results Reference
background
PubMed Identifier
3541712
Citation
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.
Results Reference
background
PubMed Identifier
2658702
Citation
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.
Results Reference
background
PubMed Identifier
2658703
Citation
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.
Results Reference
background
Citation
Intermittent Positive Pressure Breathing Trial Group. (Letter). Ann Intern Med, 100:458, 1984.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/ippb/
Available IPD/Information Identifier
IPPB
Available IPD/Information Comments
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.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/ippb/
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/ippb/
Available IPD/Information Type
Manual of Procedures
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/ippb/
Learn more about this trial
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
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