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    Summary
    EudraCT Number:2015-000463-13
    Sponsor's Protocol Code Number:MGR001-1010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000463-13
    A.3Full title of the trial
    AN OPEN STUDY TO ASSESS THE ROBUSTNESS OF THE CRC749 DEVICE BY PHARMACEUTICAL PERFORMANCE FOLLOWING TWICE DAILY DOSING OF MGR001 ADMINISTERED VIA ORAL INHALATION IN SUBJECTS WITH ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN STUDY TO ASSESS THE ROBUSTNESS OF THE CRC749 DEVICE BY PHARMACEUTICAL PERFORMANCE FOLLOWING TWICE DAILY DOSING OF MGR001 ADMINISTERED VIA ORAL INHALATION IN SUBJECTS WITH ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    A.4.1Sponsor's protocol code numberMGR001-1010
    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 SponsorMylan Pharma UK Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportMylan Pharma UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMylan Pharma UK Ltd
    B.5.2Functional name of contact pointRichard Allan
    B.5.3 Address:
    B.5.3.1Street AddressMylan Global Respiratory Group
    B.5.3.2Town/ citySandwich, Kent
    B.5.3.3Post codeCT13 9FF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441304 626255
    B.5.6E-mailrichard.allan@mylan.co.uk
    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.3.2Product code MGR001
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.2Current sponsor codePF-00345407
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.2Current sponsor codePF-00241939
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma or chronic obstructive
    pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Asthma or chronic obstructive
    pulmonary disease (COPD)
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the robustness of the CRC749 inhaler following 21 (±3) days BID dosing and one dose in the clinic on Day 22 (±3) via oral inhalation of MGR001 (250/50 μg).
    - The MGR001 product will be considered robust if inhalers returned in a testable condition meet the proposed commercial specification upon in vitro testing of pharmaceutical performance
    E.2.2Secondary objectives of the trial
    To confirm the safety of MGR001 (250/50 μg) following 21 (±3) days BID dosing and one dose in the clinic on Day 22 (±3) via oral inhalation.

    To confirm the number of confirmed CRC749 inhaler failures following 21 (±3) days BID dosing and one dose in the clinic on Day 22 (±3) via oral inhalation of MGR001 (250/50 μg).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Asthma

    1. Evidence of a personally signed and dated informed consent (and assent, if applicable) document indicating that the subject (and parent/legal guardian, if applicable) has been informed of all pertinent aspects of the study.

    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, and all other study procedures.

    3. Male or female subjects aged ≥12 years at the time of consent. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential (including adolescents) must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study.

    4. A physician diagnosed history of asthma for at least 12 weeks prior to Visit 1 - Screening.

    5. Stable treatment using an established maintenance therapy for asthma at a
    constant dosage or regular use of rescue medication (i.e. ≥2 doses of SABA
    per week) during the last 4 weeks prior to Visit 1 - Screening.

    6. Asthma subjects should have a Visit 1 - Screening pre-bronchodilator FEV1 ≥50% of predicted values according to age, height, race and sex.

    7. Subjects must be able to use the inhaler as assessed at Visit 2 - (Day 1) (according to the Instructions for Use).

    COPD

    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

    2. Subjects who are willing and able to comply with scheduled visits, treatment plan and all other study procedures

    3. Male or female subjects aged ≥40 years at the time of consent. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study

    4. A physician diagnosed history of COPD for at least 12 weeks prior to Visit 1 - Screening

    5. Stable treatment using an established maintenance therapy or regular rescue therapy (e.g. ≥2 doses of SABA and/or SAMA per day) for COPD at a constant dosage during the last 4 weeks prior to Visit 1 - Screening

    6. COPD subjects should have a Visit 1 - Screening post-bronchodilator FEV1 ≥40% predicted according to age, height, race and sex and FEV1/FVC ratio of <0.7

    7. Subjects must be able to use the inhaler as assessed at Visit 2 - (Day 1) (according to the Instructions for Use)
    E.4Principal exclusion criteria
    Asthma/COPD
    •Lower respiratory tract infection requiring treatment with antibiotics during 28 days preceding Visit1-Screening or prior to Visit2-Day1
    •History of malignancy of any organ system treated or untreated, within past 5 years whether or not there is evidence of local recurrence or metastases. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell or localized squamous carcinoma of the skin if the patient has been treated and is considered cured
    •If currently using ICS/LABA, LABA or ICS, an inability to stop medication the day prior Visit2-Day1 and switch to MGR001 for duration of study
    •Use of prescription or non-prescription drugs:
    -Medication contraindicated in Advair Diskus or salbutamol product labels or with potential to affect the course of asthma or interact with sympathomimetic amines are excluded within 28 days of first dose of study treatment and throughout study
    -Potent cytochrome P-450 3A4 inhibitors (eg ritonavir and ketoconazole)
    -Non-cardioselective beta-blockers
    -Tricyclic anti-depressants (regardless of indication)
    -Phenothiazines, eg chlorpromazine
    -Monoamine oxidase inhibitors
    -Herbal medicines
    •Suspected hypersensitivity to sympathomimetic drug (eg salmeterol or salbutamol) or orally inhaled, intranasal or systemic corticosteroid therapy or ingredients of study drug (eg lactose) or severe milk protein allergy
    •Subjects in whom Advair Diskus/Seretide Accuhaler are contraindicated
    •Known history of hypothalamic pituitary adrenal axis dysfunction eg hypo/hyper-adrenalism

    Asthma
    1.Presence or recent history, based on complete medical history, full physical examination or 12-lead ECG of any other active, severe, progressive, and/or uncontrolled clinical disease (eg renal, hepatic, gastrointestinal, metabolic, endocrine, cardiac, pulmonary, or neurological) other than asthma: Poorly controlled Type1 or Type2 diabetes, Seizure disorder or epilepsy, Cerebrovascular accident, Significant cardiac conduction abnormalities
    Stable, well-controlled conditions such as allergic rhinitis, controlled hypertension, thyroid disease, controlled Type1 and Type2 diabetes, hypercholesterolemia or gastroesophageal reflux are acceptable provided symptoms and medication would not compromise safety or interfere with tests and interpretation of the study would be allowed

    2.Evidence of significant respiratory conditions other than asthma and allergic rhinitis, inc. but not limited to: severe nasal polyposis or chronic rhinosinusitis, COPD, clinically significant bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis

    3.Significant (determined by Investigator) disease instability/uncontrolled asthma, necessitating exclusion from study following Investigator review

    4.History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)

    5.In-patient hospitalization (not inc. ER visits) for an asthma exacerbation within past Year

    6.An asthma exacerbation in the month prior to Visit1-Screening or prior to Visit2-Day1 (defined as worsening asthma symptoms requiring change in regular asthma maintenance medication or short course of systemic corticosteroid therapy)

    7.History of seasonally unstable asthma where the season will coincide with subject’s participation in the study

    11. Use of prescription or non-prescription drugs: Systemic corticosteroids for treatment of asthma

    COPD
    1.Alpha-1 anti-trypsin deficiency

    2.Other chronic or active respiratory disorder (eg clinically significant bronchiectasis, pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis)

    3.Symptoms of or treatment for an AECOPD requiring antibiotics and/or oral/systemic
    corticosteroids or in-patient hospitalization during the 28 days preceding Visit1-Screening or prior to Visit2-Day1. An AECOPD is defined as an acute event in the natural course of the disease warranting a change in the patient’s regular medication specifically to address the exacerbation event, characterized by:
    a.worsening, beyond normal day-to-day variation, of two or more of the following major symptoms for at least two consecutive days: Dyspnea, Sputum volume, Sputum purulence, OR
    b.worsening, beyond normal day-to-day variation, of any one major symptom outlined above plus any one of the following minor symptoms for at least two consecutive days: Sore throat, Colds (nasal discharge and/or nasal congestion), Fever without other cause, Increased cough or wheeze

    5.History or presence of pulmonary hypertension (diagnosed via cardiac catheterization), respiratory failure, cor pulmonale or right ventricular failure

    6.History of pulmonary lobectomy, lung volume reduction surgery (within prior 12 months) or lung transplantation
    E.5 End points
    E.5.1Primary end point(s)
    Post use in vitro testing of pharmaceutical performance:
    - Microbiology
    - Emitted Dose Content Uniformity
    - Aerodynamic Particle Size Distribution
    - Assay
    - Degradation Products
    - Water content
    E.5.1.1Timepoint(s) of evaluation of this end point
    Device robustness in vitro testing will be conducted post use, that is after Day 22 +/- 3 days
    E.5.2Secondary end point(s)
    Safety
    - Adverse Events

    Inhaler Use
    - Number of returned inhalers compared with issued inhalers
    - Number of returned inhalers that are suitable for in vitro testing
    - Number of confirmed inhaler failures following investigation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events will be collected from the time of consent to 30 days after the last dose of study medication

    To confirm the number of confirmed CRC749 inhaler failures testing will be conducted post use, that is after Day 22 +/- 3 days
    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
    Device robustness
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Device Robustness
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned2
    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 years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    Subjects will be allowed to return to their previous maintenance therapy if deemed appropriate by the Investigator
    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 Decision2015-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-12
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