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    Summary
    EudraCT Number:2013-004223-37
    Sponsor's Protocol Code Number:CQVA149ADE04
    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:2014-02-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004223-37
    A.3Full title of the trial
    A randomized, multicenter, open-label, cross-over study to assess lung function and patient preference after a 4 week treatment each with QVA149 vs. tiotropium in patients with stable chronic obstructive pulmonary disease (COPD) and moderate to severe airflow limitation who are on a tiotropium therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess lung function and patient preference after a 4 week treatment each with QVA149 vs. tiotropium in patients with stable chronic obstructive pulmonary disease (COPD) and moderate to severe airflow limitation who are on a tiotropium therapy
    A.3.2Name or abbreviated title of the trial where available
    FAVOR
    A.4.1Sponsor's protocol code numberCQVA149ADE04
    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 85 microgramms/43 microgramms, inhalation powder hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameUltibro Breezhaler 85 microgramms/43 microgramms, inhalation powder hard capsule
    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.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 Spiriva 18 Mikrogramm Kapsel mit Inhalationspulver
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSpiriva 18 Mikrogramm Kapsel mit Inhalationspulver
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 139404-48-1
    D.3.9.4EV Substance CodeSUB11095MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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
    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 16.1
    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
    To demonstrate superiority of QVA149 (100/50 µg o.d.) as compared to tiotropium (18 µg o.d.) in terms of FEV1 1 h post-inhalation after 4 weeks of treatment in patients with stable COPD and moderate to severe airflow limitation still having symptoms (CAT score of at least 10) despite treatment with tiotropium.
    E.2.2Secondary objectives of the trial
    • To evaluate patient preference for a QVA149 or tiotropium treatment after experiencing both treatment regimens
    • To evaluate investigator preference for the future treatment suggestion of the patient after experiencing both treatment regimens
    • To evaluate safety parameters of both treatment regimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adults aged ≥40 years.
    2. Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure.
    3. Patients with stable COPD according to current guidelines (GOLD 2013).
    4. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit 2.
    5. Current or ex-smokers who have a smoking history of at least 10 pack years (10 pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at Visit 1 (Screening).
    6. Patients on stable tiotropium (18 µg/d) monotherapy (tiotropium monotherapy + ICS is allowed) administered via HandiHaler® and adherent, with good device technique for at least 8 weeks before Visit 1 (Screening).
    7. Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding mothers (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/ml)).
    2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception (Pearl Index <1) during the study and up to at least 4 weeks after the end of treatment. UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea OR 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy).
    3. Patients 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
    • anticholinergic agents
    • long and short acting beta-2 agonists
    • sympathomimetic amines
    • lactose or any of the other excipients
    4. Patients with a history of clinically significant diseases that, in the opinion of the investigator, would put the safety of the patients at risk through study participation, or would compromise patient compliance or preclude completion of the study.
    5. Patients who have a clinically significant renal disease (moderate to severe renal impairment GFR < 50 ml/min/1.73 m2).
    6. Patients with myocardial infarctions less than 6 months prior to study entry.
    7. Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
    8. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention. (Patients with a transurethral resection of prostate (TURP) are excluded from the study. Patients who have undergone full re-section of the prostate may be considered for the study, as well as patients who are asymptomatic and stable on pharmacological treatment for the condition).
    9. Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
    10. Patients with neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which, in the opinion of the investigator, could interfere with the assessment of the efficacy and safety of the study treatment.
    11. Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
    12. Patients with a body mass index (BMI) of more than 40 kg/m2.
    13. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
    14. Patients, who have already been randomized into this trial earlier must not be included a second time.
    15. Study personnel or first degree relatives of investigator(s) must not be included in the study.
    16. Patients incapable of giving full informed consent.
    COPD specific exclusion
    17. Patients who are receiving LABA or a PDE-4 inhibitor less than 8 weeks prior to Visit 1.
    18. Patients requiring long term oxygen therapy (>12 h a day) on a daily basis for chronic hypoxia.
    19. Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids and/or hospitalization in the 6 weeks prior to Visit 1.
    20. Patients who develop a COPD exacerbation between screening and prior to treatment will not be eligible but will be permitted to be re-enrolled after a minimum of 6 weeks after the resolution of the COPD exacerbation.
    21. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
    22. Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-enrolled 6 weeks after the resolution of the respiratory tract infection.
    23. Patients with a negative reversibility test at Visit 2.
    24. Patients with any history of asthma.
    25. Patients with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
    26. Patients with a blood eosinophil count > 600/mm3 at Screening.
    27. Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently.
    28. Patients with concomitant pulmonary disease.
    29. Patients with clinically significant bronchiectasis.
    30. Patients with a diagnosis of α-1 anti-trypsin deficiency.
    31. Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.
    32. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
    33. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Demonstration of superiority of QVA149 (100/50 µg o.d.) as compared to tiotropium (18 µg o.d.) in terms of FEV1 1 h post-inhalation after 4 weeks of treatment in patients with stable COPD and moderate to severe airflow limitation still having symptoms despite treatment with tiotropium.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 4 and 8 weeks
    E.5.2Secondary end point(s)
    Evaluation of patient preference for a QVA149 or tiotropium treatment after experiencing both treatment regimens.
    Evaluation of investigator preference for the future treatment suggestion of the patient after experiencing both treatment regimens.
    Evaluation of safety parameters of both treatment regimens.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 4 and 8 weeks
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned16
    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
    LPLV
    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 months6
    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: 68
    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 state88
    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 Decision2014-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-12
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