Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000565
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
1999-10-27
Brief Title:
Clinical Study of Intermittent Positive Pressure Breathing IPPB
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: