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

March 4, 2015 updated by: Zambon SpA

Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, B- 9000
        • U.Z. Ghent
  • France
      • Lille Cedex, France, F 59037
        • Hôpital A. Calmette
  • Germany
      • Munich, Germany, 81377
        • Klinikum Großhadern
  • Italy
      • Arezzo, Italy, 52100
        • U.O. di Pneumologia-Ospedale
  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
        • Stichting St. Antonius ziekenhuis
  • Spain
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
  • United Kingdom
      • Edinburgh, United Kingdom, EH8 9AG
        • The University of Edinburgh-Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IPF according to the International Consensus Statement
  • Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis.
  • Patients in whom it was possible to determine single breath DLco.
  • Patients with newly or previously diagnosed IPF, in whom it was clinically justified to use the standardised regimen azathioprine plus prednisone

Exclusion Criteria:

  • Known intolerance to N-Acetylcysteine.
  • Patients with respiratory infections at study entry should be excluded until the infections have been treated successfully (VC and Dlco comparable with the values before the infection).
  • Patients with pre-existing disease that interferes with the evaluation of IPF: extensive old TBC lesions, significant bronchiectasis, moderate or severe COPD.
  • Patients with malignancy in the last 5 years. If the patient had a malignancy in the past and is free of malignancy for more than five years, the patient is regarded as healed.
  • Patients with heart failure.
  • Patients with hepatic function abnormalities contraindicating the use of azathioprine (i.e. clinically significant abnormalities of PTT and/or GGT).
  • Patients with a renal clearance < 10ml/min and/or hematuria and/or proteinuria of collagen vascular disease origin. A renal clearance is only performed in the presence of an abnormal serum creatinine and/or serum urea level.
  • Patients who are artificially ventilated.
  • Prednisone at a dose > 0.5 mg/kg/day (or other glucocorticoids such as triamcinolone, dexamethasone or methylprednisolone at an equivalent dose) or azathioprine at a dose > 2 mg/kg/day during the last month prior to inclusion.
  • Use of other immunosuppressives (such as cyclophosphamide and colchicine) is not allowed in the last month and for the duration of the trial.
  • Any form of anticancer therapy or methotrexate are not allowed when used for more than 1 week in the past and for the duration of the trial.
  • Amiodarone or nitrofurantoin are not allowed in the last 5 years, when used for more than 1 week in the past and for the duration of the trial.
  • Allopurinol, oxypurinol, thiopurinol, anti-oxidants (e.g. vitamin E) or glutathione supplements are not allowed in the last month and during the trial.
  • The use of interferon or other antifibrotics (e.g. pirfenidone) is not allowed in the past and during the study.
  • The use of NAC therapy at a dosage of more than 600 mg/day is not allowed in the last 3 years for a total period of more than 3 months.
  • Patients suffering or having suffered from documented active ulcer within the last 3 years.
  • Patients in whom the standardised treatment regimen is contraindicated or not justified.
  • Pregnancy.
  • Known or suspected drug or alcohol abuse.
  • Patients on other investigational compounds or participating in clinical trials on investigational compounds within the last 3 months.
  • Patients expected to be non-compliant in taking the medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
Placebo
Experimental: 1
patients taking NAC 600 mg t.i.d.
Drug: n-acetylcysteine
600 mg x 3, for 12 months
Other Names:
  • Flumucil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vital capacity (VC) and diffusion capacity for CO (DLCO)
Time Frame: at 6 and 12 months
at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical, radiologic and physiologic (CRP)-score
Time Frame: at 6 and 12 months
at 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zambon SpA

Investigators

  • Study Chair: M. Demedts, MD, U.Z.-Gasthuisberg, Leuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

July 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7112LAMC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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