NCT00000596

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1978

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1978

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1983

Completed
16.8 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

February 1, 2002

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Lung DiseasesPulmonary FibrosisSarcoidosis

Interventions

prednisoneDRUG
cyclophosphamideDRUG
dapsoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
No eligibility criteria

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Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 6849542BACKGROUND

MeSH Terms

Conditions

Lung DiseasesPulmonary FibrosisSarcoidosis

Interventions

PrednisoneCyclophosphamideDapsone

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

June 1, 1978

Study Completion

January 1, 1983

Last Updated

November 26, 2013

Record last verified: 2002-02