Diffuse Fibrotic Lung Disease

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ClinicalTrials.gov Identifier: NCT00000596

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : November 26, 2013

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Diseases Pulmonary Fibrosis Sarcoidosis	Drug: prednisone Drug: cyclophosphamide Drug: dapsone	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Primary Purpose:	Treatment
Study Start Date :	June 1978
Actual Study Completion Date :	January 1983

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases Steroids

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

No eligibility criteria

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Keogh BA, Bernardo J, Hunninghake GW, Line BR, Price DL, Crystal RG. Effect of intermittent high dose parenteral corticosteroids on the alveolitis of idiopathic pulmonary fibrosis. Am Rev Respir Dis. 1983 Jan;127(1):18-22.

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ClinicalTrials.gov Identifier:	NCT00000596
Other Study ID Numbers:	402
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	November 26, 2013
Last Verified:	February 2002

Additional relevant MeSH terms:

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Sarcoidosis Lung Diseases Pulmonary Fibrosis Respiratory Tract Diseases Lymphoproliferative Disorders Lymphatic Diseases Dapsone Prednisone Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents	Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Leprostatic Agents

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