Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000564
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-27
Brief Title:
Nocturnal Oxygen Therapy
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 compare the efficacy of long-term use of nocturnal oxygen therapy 12 hours with that of continuous low-flow oxygen therapy 24 hours in patients with chronic hypoxic lung disease
Detailed Description:
BACKGROUND
Chronic obstructive pulmonary disease is a major health problem in the United States In 1975 it was the sixth leading cause of death The economic impact of the disease in 1972 amounted to 803 million in the direct costs of disability treatment 305 billion in disability costs and 645 million in lost earnings due to premature death
Motivated in part by the significant toll of this disease a conference on the Scientific Basis of Respiratory Therapy co-sponsored by the American Thoracic Society and the Division of Lung Diseases examined the current status of the use of oxygen therapy in chronic lung disease The proceedings of the conference published in the American Review of Respiratory Disease Vol 110 No 6 December 1974 included a recommendation for clinical studies that would provide a critical assessment of the role of nocturnal oxygen therapy in the treatment of patients with chronic obstructive pulmonary disease Low-flow oxygen administered continuously was known to benefit some patients with chronic hypoxic lung disease However low-flow oxygen administration for long periods of time is cumbersome confining and expensive If nocturnal oxygen administration could be unequivocally demonstrated to be efficacious then the advantages of convenience and cost would have a favorable impact on treatment of patients and a rationale could be developed for testing this therapy in a larger group of patients
The Planning Phase of the trial was initiated in September 1976 Patient recruitment began in May 1977 The Recruitment Phase lasted 24 months The 203 patients in the trial were assigned randomly to nocturnal oxygen therapy home or continuous low-flow oxygen therapy
DESIGN NARRATIVE
Randomized fixed sample Two hundred and three patients were randomly assigned to at-home treatments of continuous oxygen therapy or nocturnal oxygen therapy Endpoints related to quality of life neuropsychological function and respiratory function and capacity Intervention lasted for 6 months to 3 years with an average intervention of 193 months
Chronic obstructive pulmonary disease is a major health problem in the United States In 1975 it was the sixth leading cause of death The economic impact of the disease in 1972 amounted to 803 million in the direct costs of disability treatment 305 billion in disability costs and 645 million in lost earnings due to premature death
Motivated in part by the significant toll of this disease a conference on the Scientific Basis of Respiratory Therapy co-sponsored by the American Thoracic Society and the Division of Lung Diseases examined the current status of the use of oxygen therapy in chronic lung disease The proceedings of the conference published in the American Review of Respiratory Disease Vol 110 No 6 December 1974 included a recommendation for clinical studies that would provide a critical assessment of the role of nocturnal oxygen therapy in the treatment of patients with chronic obstructive pulmonary disease Low-flow oxygen administered continuously was known to benefit some patients with chronic hypoxic lung disease However low-flow oxygen administration for long periods of time is cumbersome confining and expensive If nocturnal oxygen administration could be unequivocally demonstrated to be efficacious then the advantages of convenience and cost would have a favorable impact on treatment of patients and a rationale could be developed for testing this therapy in a larger group of patients
The Planning Phase of the trial was initiated in September 1976 Patient recruitment began in May 1977 The Recruitment Phase lasted 24 months The 203 patients in the trial were assigned randomly to nocturnal oxygen therapy home or continuous low-flow oxygen therapy
DESIGN NARRATIVE
Randomized fixed sample Two hundred and three patients were randomly assigned to at-home treatments of continuous oxygen therapy or nocturnal oxygen therapy Endpoints related to quality of life neuropsychological function and respiratory function and capacity Intervention lasted for 6 months to 3 years with an average intervention of 193 months
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?: