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

This study has been completed.
Sponsor:
Information provided by:
Zambon SpA
ClinicalTrials.gov Identifier:
NCT00639496
First received: March 13, 2008
Last updated: March 19, 2008
Last verified: March 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical, radiologic and physiologic (CRP)-score [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]

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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00639496

Locations
Belgium
U.Z. Ghent
Gent, Belgium, B- 9000
France
Hôpital A. Calmette
Lille Cedex, France, F 59037
Germany
Klinikum Grosshadern
Munich, Germany, 81377
Italy
U.O. di Pneumologia-Ospedale
Arezzo, Italy, 52100
Netherlands
Stichting St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Spain
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
Investigators
Study Chair: M. Demedts, MD U.Z.-Gasthuisberg, Leuven, Belgium
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Candiani, R&D Director, Zambon SpA
ClinicalTrials.gov Identifier: NCT00639496     History of Changes
Other Study ID Numbers: 7112LAMC01
Study First Received: March 13, 2008
Last Updated: March 19, 2008
Health Authority: Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Research Ethics Committee
Belgium: Institutional Review Board
Spain: Ethics Committee
Italy: Ethics Committee
France: Institutional Ethical Committee

Keywords provided by Zambon SpA:
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on October 01, 2014