Pulmonary FibrosisPhase 3IFIGENIANCT00639496
Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study testing n-acetylcysteine in people with Pulmonary Fibrosis, run by Zambon SpA at 7 sites in 7 countries.
Trial 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 combination with azathioprine after 6 and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- n-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Mar 2000to Jul 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United Kingdom1 site
The University of Edinburgh-Medical School
Edinburgh, EH8 9AG
About this study
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)
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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- n-acetylcysteine, placebo
- Keywords
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-acetylcysteineDrug
Also called Flumucil
600 mg x 3, for 12 months
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients taking NAC 600 mg t.i.d. Receives: Drug: n-acetylcysteine |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital capacity (VC) and diffusion capacity for CO (DLCO)
Measured: at 6 and 12 months
Secondary outcomes (1)
clinical, radiologic and physiologic (CRP)-score
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2000
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zambon SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Demedts, MD, Study chair, U.Z.-Gasthuisberg, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639496
- Sponsor's protocol ID
- 7112LAMC01
- Acronym
- IFIGENIA
- Status last verified
- Mar 2008
- First submitted
- 13 Mar 2008
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M; IFIGENIA Study Group. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2005 Nov 24;353(21):2229-42. doi: 10.1056/NEJMoa042976.
PubMed 16306520Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G; IFIGENIA study group. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial. Respir Res. 2009 Oct 27;10(1):101. doi: 10.1186/1465-9921-10-101.
PubMed 19860915
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00639496
- Acronym / sponsor ID
- IFIGENIA / 7112LAMC01
- Conditions
- Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Zambon SpAIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: n-acetylcysteinepatients taking NAC 600 mg t.i.d. |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-acetylcysteineAlso: Flumucil600 mg x 3, for 12 months | Drug | 1 |
| placeboPlacebo | Drug | 2 |
Primary outcome
Vital capacity (VC) and diffusion capacity for CO (DLCO)
Time frame: at 6 and 12 months
1 secondary outcome
clinical, radiologic and physiologic (CRP)-score
Time frame: at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Results publication: PubMed 16306520Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M; IFIGENIA Study Group. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2005 Nov 24;353(21):2229-42. doi: 10.1056/NEJMoa042976.
- Derived from this study: PubMed 19860915Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G; IFIGENIA study group. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial. Respir Res. 2009 Oct 27;10(1):101. doi: 10.1186/1465-9921-10-101.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Demedts, MD study chair
U.Z.-Gasthuisberg, Leuven, Belgium
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing n-acetylcysteine in people with Pulmonary Fibrosis, run by Zambon SpA at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Germany, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital capacity (VC) and diffusion capacity for CO (DLCO) (time frame: at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639496, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.