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    Summary
    EudraCT Number:2015-001743-36
    Sponsor's Protocol Code Number:PT003018-00
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-001743-36
    A.3Full title of the trial
    A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effects of PT003 and Placebo MDI on specific image based parameters in subjects with moderate to severe COPD.
    A.4.1Sponsor's protocol code numberPT003018-00
    A.5.4Other Identifiers
    Name:FLUIDDA identifierNumber:FLUI-2015-139
    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 SponsorPearl Therapeutics, 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 supportPearl Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFLUIDDA nv
    B.5.2Functional name of contact pointCaroline Beckers
    B.5.3 Address:
    B.5.3.1Street AddressGroeningenlei 132
    B.5.3.2Town/ cityKontich
    B.5.3.3Post code2550
    B.5.3.4CountryBelgium
    B.5.4Telephone number00323450 87 26
    B.5.6E-mailcaroline.beckers@fluidda.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 No
    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.3.1Product nameGlycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI)
    D.3.2Product code PT003
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.3Other descriptive nameglycopyrrolate
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.2
    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 placeboPressurised inhalation, suspension
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD includes chronic bronchitis and emphysema (= less elastic lungs, shortness of breath may occur) and is characterized by airway narrowing that is not fully reversible.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to assess the effect of treatment with GFF MDI, twice daily (BID) compared with Placebo MDI on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after two weeks treatment
    E.2.2Secondary objectives of the trial
    The secondary study objective is to compare the effects of GFF MDI on various Functional Respiratory Imaging (FRI) parameters and to compare the effects of GFF MDI and Placebo MDI on pulmonary function test (PFT) parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Give their signed written informed consent to participate.
    2. Are at least 40 years of age and no older than 80 at Visit 1.
    3. A female is eligible to enter and participate in the study if she is of:
    − Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or
    − Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (ie, in accordance with the approved product label and the instructions of the physician for the duration of the study) from Visit 1 (Screening) until 14 days after Visit 5.:
    - Complete abstinence from intercourse; or
    - Implants of levonorgestrel inserted for at least 1 month prior to the study drug administration but not beyond the third successive year following insertion; or
    - Injectable progestogen administered for at least 1 month prior to study drug administration; or
    - Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study drug administration; or
    - Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
    - An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
    - Estrogenic vaginal ring; or
    - Percutaneous contraceptive patches.
    4. A Male is eligible to enter and participate in the study if he is willing not to father a child during the study.
    5. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) (Celli, 2004) characterized by:
    − Airflow limitation that is not fully reversible. Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
    6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
    7. Severity of Disease: Subjects with an established clinical history of COPD and severity defined as:
    − At Visit 1 pre-bronchodilator FEV1/FVC ratio of <0.70.
    − At Visit 1 post-bronchodilator FEV1 must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
    8. Stability criteria: At Visit 4 if the pre-dose FEV1 value is outside of the ±20% range compared to the pre-dose FEV1 value of Visit 2, the visit may be rescheduled at the Investigator’s discretion, or the subject may be discontinued.
    9. Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
    10. Screening clinical laboratory tests must be acceptable to the Investigator.
    11. Screening ECG must be acceptable to the Investigator.
    12. Chest X-ray or CT-scan of the chest/lungs within 6 months prior to Visit 1 must be acceptable to the Investigator. Subjects who have a chest X-ray (or CT scan) that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest X-ray must be conducted at Visit 1 if the most recent chest X-ray or CT scan is more than 6 months old at the time of Visit 1.
    13. Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments.
    E.4Principal exclusion criteria
    Due to the extended exclusion criteria in this study the provided characters in this box are not sufficient. Please refer to protocol section 5: STUDY POPULATION SELECTION AND WITHDRAWAL CRITERIA for the full list of the exclusion criteria (page 31, section 5.2: Exclusion Criteria)
    E.5 End points
    E.5.1Primary end point(s)
    FRI Parameters:
    - Specific airway volume (siVaw)
    - Specific airway resistance (siRaw)

    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2, 3, 4, and visit 5.
    E.5.2Secondary end point(s)
    FRI parameters:
    - Airway volume (iVaw)
    - Airway resistance (iRaw)
    - Lobe volumes (iVlobes)
    - Air trapping
    - Internal lobar airflow distribution
    - Low attenuation or emphysema score
    - Blood vessel density or fibrosis score
    - Airway wall thickness
    - Mass of deposited particles per pre-defined airway section

    Spirometry parameters:
    - Forced expiratory volume in one second (FEV1)
    - Forced vital capacity (FVC)
    - Forced expiratory flow 25%-75% (FEF 25-75)
    - Tiffeneau index (FEV1/FVC ratio)
    - Inspiratory capacity (IC)

    Body plethysmography Parameters:
    - Residual volume (RV)
    - Total lung capacity (TLC)
    - Functional residual capacity (FRC)
    - Airway resistance (Raw)
    - Specific airway resistance (SRaw)
    - Specific airway conductance (SGaw)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2, 3, 4, and visit 5.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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)
    Normal treatment of COPD patients
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
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