Status:
COMPLETED
Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Zambon SpA
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00639496
Start Date
March 1 2000
End Date
July 1 2003
Last Update
March 5 2015
Active Locations (7)
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1
U.Z. Ghent
Ghent, Belgium, B- 9000
2
Hôpital A. Calmette
Lille, France, F 59037
3
Klinikum Grosshadern
Munich, Germany, 81377
4
U.O. di Pneumologia-Ospedale
Arezzo, Italy, 52100