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

March 13, 2008
March 19, 2008
March 2000
July 2003   (final data collection date for primary outcome measure)
Vital capacity (VC) and diffusion capacity for CO (DLCO) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639496 on ClinicalTrials.gov Archive Site
clinical, radiologic and physiologic (CRP)-score [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Effects of High-Dose N-Acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Fibrosis
  • Drug: n-acetylcysteine
    600 mg x 3, for 12 months
    Other Name: Flumucil
  • Drug: placebo
    Placebo
  • Experimental: 1
    patients taking NAC 600 mg t.i.d.
    Intervention: Drug: n-acetylcysteine
  • Placebo Comparator: 2
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
July 2003
July 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00639496
7112LAMC01
Yes
Carlo Candiani, R&D Director, Zambon SpA
Zambon SpA
Not Provided
Study Chair: M. Demedts, MD U.Z.-Gasthuisberg, Leuven, Belgium
Zambon SpA
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP