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    Summary
    EudraCT Number:2012-000564-14
    Sponsor's Protocol Code Number:PIPF-023
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000564-14
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone
    A.3.2Name or abbreviated title of the trial where available
    PANORAMA
    A.4.1Sponsor's protocol code numberPIPF-023
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInterMune International AG.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInterMune International AG.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheorem Clinical Research GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressKönigsteiner Str. 10
    B.5.3.2Town/ cityBad Soden
    B.5.3.3Post code65812
    B.5.3.4CountryGermany
    B.5.4Telephone number+49619652280
    B.5.5Fax number+4961965228403
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fluimucil® 600 mg effervescent tablets
    D.2.1.1.2Name of the Marketing Authorisation holderZAMBON ITALIA s.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Effervescent tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLCYSTEINE
    D.3.9.3Other descriptive nameN-Acetylcysteine, (NAC)
    D.3.9.4EV Substance CodeSUB05229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEffervescent tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Idiopathic Pulmonary Fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of treatment with NAC (1800 mg/d) in patients with mild to moderate IPF on the background of pirfenidone therapy.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinical symptoms consistent with IPF of ≥3 months duration (relative to Day 1)
    2. Diagnosis of IPF ≥3 months before Day 1 (and no more than 4 years ago). Diagnosis date is defined as the first instance in which a patient was informed of having IPF or there is documented evidence of UIP diagnosed by HRCT
    3. Age ≥40 and 80 years inclusive, on Day 1
    4. Diagnosis of UIP or IPF by HRCT and surgical lung biopsy (SLB). Previous HRCT scans, typically and if available, one at the point of time of diagnosis and one more recent, made during the last year before study inclusion) will be used and assessed by a central Reading Committee.
    5. Extent of fibrotic changes (honeycombing, reticular changes) greater than the extent of emphysema on the HRCT scan
    6. No features supporting an alternative diagnosis on SLB, transbronchial biopsy (TBB), or bronchoalveolar lavage (BAL), if available. (SLB, TBB and BAL are not required for entry into the study.)
    7. Percent predicted FVC ≥50% and ≤90% at Screening, confirmed by central review
    8. Percent predicted DLCO ≥30% and ≤90% corrected by hemoglobin, at Screening, confirmed by central review.
    9. Forced expiratory volume in 1 second (FEV1)/FVC ratio ≥0.75 confirmed by central review

    Must be on a dose of pirfenidone not less than 1602 mg/day for at least 8 weeks prior to randomization at Day 1.

    10. Able to understand and sign a written informed consent form
    11. Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
    12. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide).
    E.4Principal exclusion criteria
    1. Significant clinical worsening of IPF between Screen. and Day 1, in the opinion of the Inv.
    2. Unlikely to comply with the requirements of this study, in the opinion of the Inv.
    3. Patient-reported cigarette smoking within 3 months of Screen. or unwilling to avoid use of tobacco products throughout the study
    4. Hist. of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds
    5. Known cause of interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, cryptogenic organizing pneumonia
    6. Human immunodeficiency virus (HIV), viral hepatitis B or C
    7. Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
    8. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis (as a diffuse inflammation of connective tissue and or skin)
    9. In list for lung transplantation: expected to receive a lung transplant within 6 months from Day 1
    10. Any hist. of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months (relative to Day 1). This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma, squamous skin carcinoma)
    11. Any condition other than IPF that, in the opinion of the Inv., is likely to result in the death of the patient within the next 12 months
    12. Hist. of severe hepatic impairment or end-stage liver disease
    13. Hist. of end-stage renal disease requiring dialysis
    14. Hist. of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months (relative to Day 1), including but not limited to the following:
    a. Unstable angina pectoris or myocardial infarction
    b. Congestive heart failure requiring hospitalization
    c. Uncontrolled clinically significant arrhythmias
    15. Any condition that, in the opinion of the Inv., might be significantly exacerbated by the known side effects associated with the administration of NAC taken as a single medication
    16. Known or suspected presence of a peptic ulcer
    17. Pregnancy or lactation
    18. Hist. of alcohol or substance abuse in the past 2 years
    19. Family or personal hist. of long QT syndrome
    20. Any contraindications according to the current NAC-product SPC
    21. Any of the following liver chemistry criteria above specified limits:
    a. Total bilirubin above the upper limit of normal (ULN)
    b. Aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >2 x ULN
    c. Alkaline phosphatase >2.5 x ULN
    22. Creatinine clearance (CrCl) <30 mL/min, calculated using the Cockcroft-Gault formula
    23. ECG with a heart-rate–corrected QT interval using Bazett’s formula (QTcB) >500 ms at Screening
    24. Suspected intolerance, allergy, or hypersensitivity to NAC or any of its components
    25. Known intolerance, allergy, or hypersensitivity to NAC or any of its components
    26. Use of any of the following therapies within 28 days before randomization:
    a. Any investigational therapy, defined as any drug that has not MA for any indication in the country of the participating site
    b. Corticosteroids when used for the treatment of IPF (except for durations of up to 21 days for acute IPF exacerbation). No restrictions apply to corticosteroids used for reasons other than IPF therapy (e.g., allergic reactions, sepsis); however, the specific reason for use must be recorded
    c. Any cytotoxic, immunosuppressive, cytokine-modulating, or receptor-antagonist agent, including but not limited to azathioprine, bosentan, ambrisentan, cyclophosphamide, cyclosporine, prostaglandin analogues such as iloprost, TNF-α inhibitors such as infliximab and etanercept, tyrosine kinase inhibitors such as imatinib, leukotriene receptor antagonists such as montelukast, methotrexate, mycophenolate mofetil, tacrolimus, interferon gamma-1b (IFN-y 1b)
    d. The following medications (or class) may be used during the study only if given for a non-IPF indication:
    - Antithrombotic agents: heparin group
    - Lipid-modifying agents: 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors
    - Angiotension-coverting enzyme (ACE) inhibitors and ACE receptor blockers
    - Prior treatment of NAC for the indication IPF within the last 3 months. Periodic treatment up to 28 days with NAC for approved indications within the last 6 months is allowed
    - Anti-gout preparations: colchicine
    e. Strong inhibitors or inducers of CYP1A2 such as fluvoxamine, tobacco, rifampicin
    f. Phosphodiesterase type 5 (PDE-5) inhibitors such as sildenafil, tadalafil, vardenafil (intermittent use for non-IPF indication [e.g., for erectile dysfunction] is permitted
    E.5 End points
    E.5.1Primary end point(s)
    • Tolerability assessment and safety: Review of AEs/SAEs, dose reductions and discontinuations, changes in clinical laboratory findings, and deaths
    • Worsening of the disease: Spirometry, 6MWT procedure and DLCO
    • IPF exacerbations
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Telephone interviews: W2, W8, W16, W20
    • Review of AEs/SAEs, concomitant meds, supplemental O2 use: Screening and washout, D1, W2, W4, W8, W12, W16, W20, W24, Follow-up
    • Changes in clinical laboratory findings: Screening and washout, D1, W4, W12, W24, follow-up
    • Spirometry and 6MWT procedure and Borg scale, UCSD SOBQ, DLCO: screening (DLCO only), D1, W12, W24
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
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