Diffuse Fibrotic Lung Disease
Information source: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Diseases; Pulmonary Fibrosis; Sarcoidosis
Intervention: prednisone (Drug); cyclophosphamide (Drug); dapsone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
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.
Clinical Details
Study design: Allocation: Randomized, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
No eligibility criteria
Locations and Contacts
Additional Information
Related 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.
Starting date: June 1978
Last updated: November 25, 2013
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