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    Summary
    EudraCT Number:2007-004277-26
    Sponsor's Protocol Code Number:GS-US-205-0110
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-02-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2007-004277-26
    A.3Full title of the trial
    An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis.
    A.4.1Sponsor's protocol code numberGS-US-205-0110
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/228/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences Inc
    B.1.3.4CountryUnited States
    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 supportGilead Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park, Abington
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897496
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    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 Cayston Aztreonam 75 mg powder and solvent for nebuliser solution
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/204
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZTREONAM
    D.3.9.1CAS number 78110-38-0
    D.3.9.2Current sponsor codeAZLI
    D.3.9.4EV Substance CodeSUB05664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 TOBI
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOBRAMYCIN
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis (CF) in adults and children with a lung infection caused by the bacteria Pseudomonas aeruginosa (PA).
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 comparative safety and efficacy of Aztreonam Lysine for Inhalation (AZLI) and Tobramycin
    Nebuliser Solution (TNS) in adult and pediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas
    aeruginosa (PA) infection.
    E.2.2Secondary objectives of the trial
    • Change from baseline in the Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale at
    Day 28
    • Relative change from baseline in FEV1 percent of predicted at Week 20 (end of last treatment course of AZLI
    or TNS)
    • Use of additional (non-protocol specified) antipseudomonal antibiotics during the course of the study
    • Hospitalizations during the course of the study
    • Change in PA CFUs in sputum at the end of each on-drug cycle
    • Changes from baseline in FEV1, FVC and FEF 25-75 at each study visit
    • Change from baseline in other domains as assessed by the CFQ-R at each visit
    • Changes from baseline in weight and Body Mass Index (BMI) at each visit
    • Missed school/work days during the course of the study
    Treatment Satisfaction Questionnaire for Medication (TSQM) at Day 28 and either Day 140 or ET
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males or females aged 6 years and older
    • Patients with CF as diagnosed by one of the following:
    • Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test, or
    • Documented sweat sodium ≥ 60 mmol/L, or
    • Two well characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator
    (CFTR) gene, or
    • Abnormal nasal potential difference with accompanying symptoms characteristic of CF
    • Documented PA in an expectorated sputum or throat swab culture within 3 months prior to Visit 1 or at Visit 1
    • Patients must be able to provide written informed consent/assent prior to any study related procedures; parent/
    guardian must be able to give written informed consent as necessary prior to any study related procedure
    • Patients must have received previous treatment with aerosolized antibiotics without demonstration of drug
    intolerance
    • FEV1 ≤ 75% predicted at Visit 1
    • Ability to perform reproducible pulmonary function tests
    • Chest radiograph at Visit 1 without significant acute findings (eg, infiltrates [lobar or diffuse interstitial], pleural
    effusion, pneumothorax); or chest radiograph or MRI obtained within the 180 days prior to Visit 1 without acute
    findings and no significant intercurrent illness; chronic, stable findings (eg, chronic scarring or atelectasis) are
    allowed.
    Inclusion criteria for extension phase:
    • Subjects must be able to provide written informed consent/assent prior to any study related procedures; parent/
    guardian must be able to give written informed consent as necessary prior to any study related procedures
    • Subjects must have received previous treatment with aerosolized antibiotics without demonstration of drug
    intolerance
    • Completed at least one course of AZLI or TNS during the randomized portion of the study
    E.4Principal exclusion criteria
    •• Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg
    prednisone every other day
    • History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
    • Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at
    night
    • Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the
    investigational drug (whichever is longer)
    • Known local or systemic hypersensitivity to monobactam antibiotics
    • Known allergies/intolerance to tobramycin
    • Inability to tolerate inhalation of a short acting β2 agonist
    • Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
    • Administration of antipseudomonal antibiotics by inhalation, intravenous or oral routes within the 14 days prior
    to Visit 1
    • Changes in antimicrobial, bronchodilator (BD), dornase alfa, or corticosteroid medications within 7 days prior
    to Visit 1
    • Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
    • History of lung transplantation
    • Abnormal renal or hepatic function or serum chemistry at Visit 1, defined as:
    - AST, ALT > 5 times upper limit of normal range (ULN)
    - Creatinine > 2 times ULN
    • Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
    • Female of childbearing potential who is lactating or is not (in the opinion of the investigator) practicing an
    acceptable method of birth control; female subjects who utilize hormonal contraceptives as one of their birth
    control methods must have used the same method for at least 3 months before study dosing
    • Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere
    with patient treatment, assessment, or compliance with the protocol
    Exclusion criteria for extension phase:
    • Known local or systemic hypersensitivity to monobactam antibiotics
    • Inability to tolerate inhalation of a short acting β2 agonist
    • Positive urine pregnancy test; all women of childbearing potential will be tested
    • Female of childbearing potential who is lactating or is not (in the opinion of the investigator) practicing an
    acceptable method of birth control
    • Concurrent participation in a study of another investigational medication or device
    • Use of another investigational product (with the exception of AZLI) within the last 28 days
    • Terminated early from the randomized portion of the study, but not yet reached the 6 month time point for entry
    into the AZLI extension phase
    E.5 End points
    E.5.1Primary end point(s)
    Relative change from baseline in FEV1 percent predicted at Day 28 (non-inferiority analysis) (Analysis EMEA)

    Relative change from baseline in FEV1 percent of predicted across 3 treatment courses (superiority analysis) (Analysis FDA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    See Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 59
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 46
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 209
    F.1.3Elderly (>=65 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 268
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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