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

This study has been completed.
Information provided by (Responsible Party):
Zambon SpA Identifier:
First received: March 13, 2008
Last updated: March 4, 2015
Last verified: March 2008
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.

Condition Intervention Phase
Pulmonary Fibrosis Drug: n-acetylcysteine Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:

Further study details as provided by Zambon SpA:

Primary Outcome Measures:
  • Vital capacity (VC) and diffusion capacity for CO (DLCO) [ Time Frame: at 6 and 12 months ]

Secondary Outcome Measures:
  • clinical, radiologic and physiologic (CRP)-score [ Time Frame: at 6 and 12 months ]

Enrollment: 184
Study Start Date: March 2000
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients taking NAC 600 mg t.i.d.
Drug: n-acetylcysteine
600 mg x 3, for 12 months
Other Name: Flumucil
Placebo Comparator: 2 Drug: placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00639496

U.Z. Ghent
Gent, Belgium, B- 9000
Hôpital A. Calmette
Lille Cedex, France, F 59037
Klinikum Grosshadern
Munich, Germany, 81377
U.O. di Pneumologia-Ospedale
Arezzo, Italy, 52100
Stichting St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
United Kingdom
The University of Edinburgh-Medical School
Edinburgh, United Kingdom, EH8 9AG
Sponsors and Collaborators
Zambon SpA
Study Chair: M. Demedts, MD U.Z.-Gasthuisberg, Leuven, Belgium
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Zambon SpA Identifier: NCT00639496     History of Changes
Other Study ID Numbers: 7112LAMC01
Study First Received: March 13, 2008
Last Updated: March 4, 2015

Keywords provided by Zambon SpA:
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on August 18, 2017