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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 March 2015
Main ID:  NCT00639496
Date of registration: 13/03/2008
Prospective Registration: No
Primary sponsor: Zambon SpA
Public title: Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) IFIGENIA
Scientific 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)
Date of first enrolment: March 2000
Target sample size: 184
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00639496
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  
Phase:  Phase 3
Countries of recruitment
Belgium France Germany Italy Netherlands Spain United Kingdom
Contacts
Name:     M. Demedts, MD
Address: 
Telephone:
Email:
Affiliation:  U.Z.-Gasthuisberg, Leuven, Belgium
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Pulmonary Fibrosis
Intervention(s)
Drug: n-acetylcysteine
Drug: placebo
Primary Outcome(s)
Vital capacity (VC) and diffusion capacity for CO (DLCO) [Time Frame: at 6 and 12 months]
Secondary Outcome(s)
clinical, radiologic and physiologic (CRP)-score [Time Frame: at 6 and 12 months]
Secondary ID(s)
7112LAMC01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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