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| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | October 27, 1999 | ||||||||||||||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||||||||||||||
| Start Date ICMJE | November 1976 | ||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00000565 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Clinical Study of Intermittent Positive Pressure Breathing (IPPB) | ||||||||||||||||||||||||
| Official Title ICMJE | |||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized | ||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: intermittent positive-pressure breathing | ||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema. |
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 30 Years to 74 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | |||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT ID ICMJE | NCT00000565 | ||||||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||||||
| Study ID Numbers ICMJE | 203 | ||||||||||||||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||
| Verification Date | May 2002 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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