Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000596 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Diseases Pulmonary Fibrosis Sarcoidosis |
Drug: prednisone Drug: cyclophosphamide Drug: dapsone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Study Start Date: | June 1978 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 402 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000596 |
Health Authority: | United States: Federal Government |
Prednisone Lymphatic Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis Lung Diseases |
Dapsone Cyclophosphamide Sarcoidosis Lymphoproliferative Disorders Pulmonary Fibrosis |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Immunosuppressive Agents |
Glucocorticoids Pharmacologic Actions Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |