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    Summary
    EudraCT Number:2014-004680-21
    Sponsor's Protocol Code Number:CQVA149ADE05
    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:2015-02-26
    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 number2014-004680-21
    A.3Full title of the trial
    A randomized, double-blinded, single-center, placebo controlled, cross-over study to assess the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) on cardiac function in patients with chronic obstructive pulmonary disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the effect of QVA149 on cardiac functions in COPD patients
    A.4.1Sponsor's protocol code numberCQVA149ADE05
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.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 Ultibro Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.2Product code QVA149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNIndacaterol maleate
    D.3.9.1CAS number 753498-25-8
    D.3.9.2Current sponsor codeQAB149
    D.3.9.3Other descriptive nameINDACATEROL MALEATE
    D.3.9.4EV Substance CodeSUB30300
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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.3.9.2Current sponsor codeNVA237
    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 number50
    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.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, hard capsule
    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
    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 19.0
    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
    To determine the effect of once-daily QVA149 (110/50 µg o.d.) compared with placebo on left ventricular enddiastolic volume as measured by MRI after 2 weeks of treatment in hyperinflated COPD patients.

    E.2.2Secondary objectives of the trial
    • To evaluate the effects of QVA149 compared to placebo on lung function parameters after 14 days of treatment, as measured by:
    o Forced spirometry (75 min post-dose)
    - FEV1 and FVC
    o Bodyplethysmography (60 min post-dose):
    - inspiratory capacity (IC)
    - total lung capacity (TLC)
    - residual volume (RVol)
    - specific airway resistance (sRaw)
    - functional residual capacity (FRC)

    To evaluate the effects of QVA149 compared to placebo on cardiac parameters, as measured by MRI after 14 days of treatment:
    o right and left ventricular ejection fraction
    o right and left ventricular endsystolic volumes
    o right ventricular enddiastolic volume
    o cardiac output
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male or female subjects, aged ≥ 40 years, giving written Informed Consent and who are willing and capable to comply with all study procedures.
    3. Patients with stable COPD according to the current GOLD guidelines (GOLD 2014).
    4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FC<0.7 at Visit 3. Post-bronchodilator refers to within 10-15 min after inhalation of 400 µg (4x100 µg) of salbutamol.
    5. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
    6. Hyperinflated patients with RVol>135% predicted as measured at Visit 3, before intake of salbutamol.
    E.4Principal exclusion criteria
    1. Pat. with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof
    • anticholinergics
    • long and short acting beta-2 agonists
    • sympathomimetic amines
    • lactose or any of the other excipients
    2. Pat. with a history of long QT syndrome or whose QTcF (Fredericia method) measured at Visit 3 is prolonged (>450 ms for males and >470 ms for females). These patients should not be re-screened.
    3. Pat. who have a clinically significant abnormality on the ECG at Visit 3, who in the judgment of the investigator would be at potential risk if enrolled into the study. These patients should not be re-screened.
    4. Pat. who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment
    5. Pat. with a known history or current atrial fibrillation to be confirmed by ECG at Visit 3.
    6. Pat. with pacemaker or bypass.
    7. Pat. with a mean sitting systolic blood pressure >160 mmHg and/or mean sitting diastolic blood pressure >90 mmHg at Visit 3. These pats. will be permitted to be rescreened after having achieved controlled disease status following initiation or intensification of antihypertensive therapy. Re-screening can start at Visit 2, 4 weeks after change of antihypertensive medication.
    8. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to history of hepatic disease, renal disease, hematological disease, neurological and psychiatric disease, endocrine disease or pulmonary disease other than COPD (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
    9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    10. Pat. with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or severe renal impairment (GFR<30 mL/min/1.73 m2) including those with end-stage renal disease requiring dialysis or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered.
    11. Pat. with Type I or uncontrolled Type II diabetes.
    12. Pat. with active/ clinical history of asthma.
    13. Pat. unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan. A separate MRI patient informed consent form including MRI safety will be signed by the patient before each MRI exam.
    14. History of lower respiratory tract infection within four weeks prior to Visit 2 and between Visit 2 and Visit 4. These patients will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection and can re-start at Visit 2.
    15. History of one COPD exacerbation that required treatment with antibiotics, systemic steroids or hospitalization within 3 months prior to Visit 2.
    16. More than one COPD exacerbation that required treatment with antibiotics, systemic steroids or hospitalization within 6 months prior Visit 2.
    17. Pat. who develop a COPD exacerbation between Visit 2 and Visit 4 will not be eligible but will be permitted to be re-screened after a minimum of 3 months after the resolution of the COPD exacerbation and can re-start at Visit 2.
    18. Pat. requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
    19. Pat. with active pulmonary tuberculosis, unless confirmed by imaging in the last year to be no longer active.
    20. Pat. with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
    21. Pat. with a diagnosis of alpha 1 anti-trypsin deficiency.
    22. Pat. with a body mass index of more than 40 kg/m2.
    23. Pat. participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study
    24. Pat. who are, in the opinion of the investigator known to be unreliable or non-compliant.
    25. Relevant history of drug or alcohol abuse as judged by the investigator.
    26. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
    27. Use of other investigational drug at the time of enrollment, or within 30 days or 5 half-lives of Visit 1, whichever is longer.
    28. Pat. receiving any medication in the classes listed in Table 5-1 and Table 5-2.
    29. Pat. receiving medication in the classes listed in Table 5-3 should be excluded unless the medication has been stable for the specified period and the stated conditions have been met.
    30. Women who are pregnant or breast feeding
    31. Women of child-bearing potential
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the left ventricular enddiastolic volume assessed by MRI after 2 weeks of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    E.5.2Secondary end point(s)
    All secondary endpoints (lung function- and other cardiac function parameters) will be analyzed analogous to the primary endpoint. Exploratory endpoints and Qol-measurements will be analyzed descriptively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 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 Yes
    E.6.4Safety No
    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) 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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state62
    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)
    After participation in the trial, patients will be treated with a COPD-therapy at the discretion of the investigator and in line with currently valid treatment guidelines.
    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 Decision2015-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-15
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