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

Zambon

Status and phase

Completed

Phase 3

Conditions

Pulmonary Fibrosis

Treatments

Drug: placebo

Drug: n-acetylcysteine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00639496

7112LAMC01

Details and patient eligibility

About

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.

Enrollment

184 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.