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    Summary
    EudraCT Number:2014-000611-14
    Sponsor's Protocol Code Number:201314
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-000611-14
    A.3Full title of the trial
    A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD
    A.4.1Sponsor's protocol code number201314
    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 SponsorGlaxoSmithKline Research & Development 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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 4466
    B.5.5Fax number+44208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Incruse 55 micrograms inhalation powder, pre-dispensed
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUmeclidinium
    D.3.2Product code GSK573719
    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 INNUMECLIDINIUM BROMIDE
    D.3.9.1CAS number 869113-09-7
    D.3.9.2Current sponsor codeGSK573719
    D.3.9.3Other descriptive name1-[2-(Benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide
    D.3.9.4EV Substance CodeSUB119778
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    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 placeboInhalation powder, pre-dispensed
    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
    in subjects with Chronic Obstructive Pulmonary Disease COPD
    E.1.1.1Medical condition in easily understood language
    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 17.1
    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 is to evaluate the efficacy and safety of the addition of UMEC 62.5mcg once-daily to ICS/LABA therapy, compared with placebo once-daily plus ICS/LABA therapy over 12 weeks in subjects with COPD.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the addition of UMEC 62.5mcg once-daily to ICS/LABA therapy, compared with placebo once-daily plus ICS/LABA therapy on COPD-related health status assessments over 12 weeks in subjects with COPD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type of subject: Outpatient.
    2. Informed Consent: A signed and dated written informed consent prior to study participation.
    3. Age: Subjects 40 years of age or older at Visit 1.
    4. Gender: Male and female subjects are eligible to participate in the study.
    OR
    Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact):
    - Abstinence
    - Oral Contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
    - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.
    - Double barrier method: condom and an occlusive cap (diaphragm or
    cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
    5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].
    6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history.
    7. Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using reference values provided by Quanjer [Quanjer, 2012].
    8. Current clinically prescribed medication: The subject must be on the dose and frequency of one of the following ICS/LABA combinations approved for COPD at least 30 days prior screening
    - FSC at a dose of 500/50mcg twice-daily (i.e. Seretide Diskus or approved generic productsuch as AirFluSal Forspiro500/50mcg twice daily or Rolenium Elpenhaler 500/50mcg twice daily)
    - The combination of budesonide/formoterol (i.e., Symbicort Turbuhaler) at doses of 200/6 mcg twice-daily or 400/12mcg twice-daily .
    - ICS/LABA combinations (including generics) approved for COPD at approved doses and frequency not mentioned above but stipulated in the SPM.
    9. Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1.
    E.4Principal exclusion criteria
    1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
    2. Asthma: A current diagnosis of asthma.
    3. Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. Please view protocol for further information.
    4. Other Diseases/Abnormalities: The subject is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediately life-threatening illness e.g. cancer.
    5. Contraindications: Any history of allergy or hypersensitivity to any
    anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate. .
    6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
    7. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
    8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
    9. Unstable or life threatening cardiac disease: Umeclidinium should be used with caution in subjects with severe cardiovascular disease. Please view protocol for further information.
    10.12-Lead ECG: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Please view protocol for further information.
    11.Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk.
    12.Interactions: Concomitant administration with beta-blockers and strong CYP3A4 inhibitors is only permitted if, in the Investigator’s opinion, the likely benefit outweighs the potential risk.
    13.Severe Hepatic Impairment: Patients with severe hepatic impairment (Child- Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk.
    14.Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
    15.Medications Prior to Screening: please view table and further information within the protocol.
    16.Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., 12 hours per day) is not exclusionary.
    17.Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
    18.Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1, or who will enter the acute phase of a pulmonary rehabilitation program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
    19.Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
    20.Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator.
    21.Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.
    E.5 End points
    E.5.1Primary end point(s)
    Trough FEV1 on Day 85. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on treatment Day 84 (i.e., at Week 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 85
    E.5.2Secondary end point(s)
    Weighted mean (WM) 0-6 hour FEV1.
    Other(s)
    • Proportion of subjects achieving an increase of ≥100mL above baseline in trough FEV1
    • Trough FEV1 and weighted mean FEV1 over 0-6 hours post-dose at other time points
    • Proportion of subjects achieving an increase in FEV1 of ≥12% and ≥200mL above baseline at any time during 0-6 hour post-dose on Day 1
    • Serial FEV1 over 0 to 6 hours (at each time point)
    • Peak FEV1
    • Serial and trough forced vital capacity (FVC)
    • Rescue albuterol/salbutamol use (percentage of rescue-free days and puffs/day)
    • TDI focal score
    • Proportion of TDI responders as defined by a 1 unit or greater score

    Safety
    • Incidence of adverse events
    • Vital signs (pulse rate and systolic and diastolic pressure)
    • COPD Exacerbations

    Health-Related Quality of Life/Health Outcomes
    • St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) total score
    • COPD Assessment Test (CAT) score
    • Proportion of SGRQ responders as defined by a 4 unit or greater reduction in score over baseline
    • Proportion of CAT responders as defined by a 2 unit or greater improvement in score over baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    post-dose on Treatment Day 84 (Week 12)
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 days21
    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 days21
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 230
    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)
    The investigator is responsible for ensuring that consideration has been given to the post study care of the patient’s medical condition whether or not GSK is providing specific post study treatment.

    GSK will not provide post-study treatment. There are no plans to provide study medication for compassionate use following study completion. At the end of the treatment period (Visit 7 or Early Withdrawal), subjects can resume conventional COPD therapy as prescribed 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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-24
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