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Diffuse Fibrotic Lung Disease

Primary Purpose

Lung Diseases, Pulmonary Fibrosis, Sarcoidosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
prednisone
cyclophosphamide
dapsone
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    November 25, 2013
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000596
    Brief Title
    Diffuse Fibrotic Lung Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1978 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1983 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Pulmonary Fibrosis, Sarcoidosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    prednisone
    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    dapsone

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6849542
    Citation
    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. doi: 10.1164/arrd.1983.127.1.18.
    Results Reference
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    Diffuse Fibrotic Lung Disease

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