Lung DiseasesPhase 3NCT00000565
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
A Phase 3 study testing intermittent positive-pressure breathing in people with Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- What is being tested?
- intermittent positive-pressure breathing
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 1976to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
About this study
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.
Read the 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.
- Being tested
- intermittent positive-pressure breathing
- Medical subject headings
- Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent positive-pressure breathingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startNov 1976
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Nicholas Anthonisen, University of ManitobaJohn Hodgkin, Loma Linda University Medical CenterPhilip Hopewell, San Francisco General HospitalDavid Levin, University of OklahomaPaul Stevens, Baylor College of MedicineElizabeth Wright, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000565
- Sponsor's protocol ID
- 203
- Status last verified
- May 2002
- First submitted
- 27 Oct 1999
- Last updated
- 14 Apr 2016
- Results posted
- No
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.
PubMed 6357018Prigatano 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.
PubMed 6826857Prigatano 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.
PubMed 6380440Nagai 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.
PubMed 3904548Nagai 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.
PubMed 3904549West 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.
PubMed 3541712Wilson 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.
PubMed 2658702Matsuba 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.
PubMed 2658703Intermittent Positive Pressure Breathing Trial Group. (Letter). Ann Intern Med, 100:458, 1984.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
- ClinicalTrials.gov ID
- NCT00000565
- Acronym / sponsor ID
- 203
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Nov 1976
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent positive-pressure breathing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- BackgroundNational Heart, Lung, and Blood Institute, Division of Lung Diseases: Protocol for Intermittent Positive Pressure Breathing Collaborative Program. Bethesda, Maryland: National Institutes of Health, 1978.
- BackgroundHodgkin 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.
- Background: PubMed 6357018Intermittent 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.
- Background: PubMed 6826857Prigatano 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.
- Background: PubMed 6380440Prigatano 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.
- Background: PubMed 3904548Nagai 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.
- Background: PubMed 3904549Nagai 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.
- Background: PubMed 3541712West 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.
- Background: PubMed 2658702Wilson 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.
- Background: PubMed 2658703Matsuba 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.
- BackgroundIntermittent Positive Pressure Breathing Trial Group. (Letter). Ann Intern Med, 100:458, 1984.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Anthonisen
University of Manitoba
John Hodgkin
Loma Linda University Medical Center
Philip Hopewell
San Francisco General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intermittent positive-pressure breathing in people with Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000565, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.