Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000596
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Diffuse Fibrotic Lung Disease
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:
2002-02
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 determine the effects of cyclophosphamide compared with prednisone dapsone or high-dose intermittent pulse therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis Also to evaluate the use of intermittent short-term high-dose intravenous corticosteroids in patients with sarcoidosis There were actually four separate clinical trials
Detailed Description:
BACKGROUND
The fibrotic lung diseases represent 15 to 20 percent of the non-infectious disorders of the lung Idiopathic pulmonary fibrosis one of the 10 general groups of fibrotic lung disorders is a chronic and devastating illness resulting in death within an average of 4 to 5 years from the onset of symptoms Although 5 to 10 percent of these patients respond to corticosteroids there is no known treatment for the remainder
Sarcoidosis a generalized disorder characterized by epithelioid cell granuloma formation in affected organs especially the lung and lymphoid tissue has a clinical course that varies considerably from patient to patient and in some cases resolves spontaneously In other cases intermittent pneumonitis develops which may result in a permanent loss of lung function Large intermittent doses of corticosteroids might be superior to conventional high-dose corticosteroids in patients with pulmonary sarcoidosis which has not resolved spontaneously
DESIGN NARRATIVE
In the randomized non-blind cyclophosphamide versus prednisone trial 25 to 50 patients with idiopathic pulmonary fibrosis were assigned to treatment with prednisone or cyclophosphamide At the end of 52 weeks of drug therapy both groups were treated using conventional medical therapies In the non-randomized dapsone trial 10 fibrotic patients were treated with dapsone and prednisone for one year In the double-blind randomized methylprednisolone trial 25 to 50 patients were given low-dose methylprednisolone and in addition all patients were randomized to either high-dose methylprednisolone treatment or to placebo at weekly intervals for one year In the randomized double-blind high-dose corticosteroid trial 25 to 50 patients with pulmonary sarcoidosis were given a short intense course of high-dose methylprednisolone or a placebo for 6 weeks
The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record
The fibrotic lung diseases represent 15 to 20 percent of the non-infectious disorders of the lung Idiopathic pulmonary fibrosis one of the 10 general groups of fibrotic lung disorders is a chronic and devastating illness resulting in death within an average of 4 to 5 years from the onset of symptoms Although 5 to 10 percent of these patients respond to corticosteroids there is no known treatment for the remainder
Sarcoidosis a generalized disorder characterized by epithelioid cell granuloma formation in affected organs especially the lung and lymphoid tissue has a clinical course that varies considerably from patient to patient and in some cases resolves spontaneously In other cases intermittent pneumonitis develops which may result in a permanent loss of lung function Large intermittent doses of corticosteroids might be superior to conventional high-dose corticosteroids in patients with pulmonary sarcoidosis which has not resolved spontaneously
DESIGN NARRATIVE
In the randomized non-blind cyclophosphamide versus prednisone trial 25 to 50 patients with idiopathic pulmonary fibrosis were assigned to treatment with prednisone or cyclophosphamide At the end of 52 weeks of drug therapy both groups were treated using conventional medical therapies In the non-randomized dapsone trial 10 fibrotic patients were treated with dapsone and prednisone for one year In the double-blind randomized methylprednisolone trial 25 to 50 patients were given low-dose methylprednisolone and in addition all patients were randomized to either high-dose methylprednisolone treatment or to placebo at weekly intervals for one year In the randomized double-blind high-dose corticosteroid trial 25 to 50 patients with pulmonary sarcoidosis were given a short intense course of high-dose methylprednisolone or a placebo for 6 weeks
The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record
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?: