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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 1999
    Last Updated
    April 13, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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/

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    Clinical Study of Intermittent Positive Pressure Breathing (IPPB)

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