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Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

NCT00639496 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2015-03-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6 and 12 months.

Conditions

Interventions

DRUG

n-acetylcysteine

600 mg x 3, for 12 months

DRUG

placebo

Placebo

Sponsors & Collaborators

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • M. Demedts, MD · U.Z.-Gasthuisberg, Leuven, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639496 on ClinicalTrials.gov