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    Summary
    EudraCT Number:2019-004095-19
    Sponsor's Protocol Code Number:TIO-II-19-1
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-19
    Trial 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-004095-19
    A.3Full title of the trial
    A pharmacodynamic, randomised, single dose, cross-over study to compare the bronchodilator effect of a new formulation of Tiotropium DPI versus Spiriva® 18 μg Handihaler®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single dose study to compare the effect of bronchodilatation of two formulations of SMB tiotropium products versus the marketed product Spiriva® 18 μg Handihaler®
    A.4.1Sponsor's protocol code numberTIO-II-19-1
    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 SponsorLaboratoires SMB S.A.
    B.1.3.4CountryBelgium
    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 supportLaboratoires SMB S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires SMB S.A.
    B.5.2Functional name of contact pointClinical Trial Department
    B.5.3 Address:
    B.5.3.1Street AddressRue de la Pastorale 26-28
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1080
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3224114828
    B.5.5Fax number+3224112828
    B.5.6E-mailDptClinique@smb.be
    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 nameTIOTROPIUM 8.8 µg DPI
    D.3.4Pharmaceutical form Capsule, hard
    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 ANHYDROUS
    D.3.9.3Other descriptive nameANHYDROUS TIOTROPIUM BROMIDE
    D.3.9.4EV Substance CodeSUB25692
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.8
    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 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 nameTIOTROPIUM 2.2 µg DPI
    D.3.4Pharmaceutical form Capsule, hard
    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 ANHYDROUS
    D.3.9.3Other descriptive nameANHYDROUS TIOTROPIUM BROMIDE
    D.3.9.4EV Substance CodeSUB25692
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    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 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: 3
    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(r) Handihaler(r) 18μg inhalation powder
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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.3.4Pharmaceutical form Capsule, hard
    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 MONOHYDRATE
    D.3.9.1CAS number 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    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 (bronchodilating effect)
    E.1.1.1Medical condition in easily understood language
    This is a progressive lung diseases including emphysema, chronic bronchitis, and non-reversible asthma. This disease is characterized by increasing breathlessness.
    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 21.1
    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
    Primary Objective
    - To assess the non-inferiority between Tiotropium DPI capsule 8.8μg and Spiriva® 18μg Handihaler® by measurement of the bronchodilating effect
    E.2.2Secondary objectives of the trial
    • Secondary Objectives
    - To assess and compare the safety of both products.
    - To demonstrate a difference between the two dosages of SMB tiotropium
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    nclusion criteria

    Patients must satisfy the following criteria before entering the study:
    1. Male and non-pregnant female aged over 40 years old
    2. Documented history of stable COPD with moderate to severe airflow obstruction diagnosed for more than six months according to the GOLD standard prior to the screening visit
    3. FEV1 more than or equal to 30% and inferior to 80% of predicted at screening.
    4. FEV1/FVC following 200 µg salbutamol treatment intake < 0.7 at screening.
    5. Reversibility of at least 12% and 100 ml in FEV1 30-45 minutes after maximum 400 µg of salbutamol
    6. Current smokers or history of ex-smokers (≥10 pack-year smoking history).
    7. Able to comply with all study procedures, including the use of study inhalers and spirometer
    8. Provide written informed consent to participate in the study, indicated by a personal signature and date on the patient consent form
    E.4Principal exclusion criteria
    Exclusion criteria

    Patients who meet any of the following criteria will be excluded from participating in the study:
    1. Evidence of any unstable or untreated clinically significant immunological, cardiac, cardiovascular, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormality or disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk during her/his participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study
    2. Respiratory tract infection or COPD exacerbation not completely resolved within the last 2 weeks prior to the screening visit or between the screening and the randomization
    3. Abnormality of inspiratory function (e.g. laryngeal obstruction, neuromuscular disease)
    4. Need for daily oxygen therapy
    5. Asthma, allergic rhinitis, cystic fibrosis, bronchiolitis obliterans, fibrosis, active or latent tuberculosis, α1-antitrypsin deficiency or any other causes of chronic airflow limitation apart from COPD
    6. Use of any of the prohibited medications as detailed in the concomitant medication section
    7. Patients with any sensitivity or allergy to any of the products used within this clinical trial
    8. Female pregnant, breast-feeding or of childbearing potential age without efficient means of birth control (IUD, OCS, implants, hormonal patch, vaginal ring or spermicide and condom)
    9. Patients with human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV)
    10. Participation in any investigational medical studies within 2 month prior the screening visit
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:

    -Trough FEV1 response defined as change in FEV1 from baseline to FEV1 24h post-dose measurement
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2-Visit 3-Visit 4
    E.5.2Secondary end point(s)
    Secondary parameters:

    Efficacy endpoint:
    - Peak bronchodilatory effect (FEV1 max)
    - Tmax of FEV1
    - Baseline-adjusted area under the curve (AUC) for FEV1 over 24 hours post dosing
    - PEF max
    - Baseline adjusted AUC of PEF from 0 to 24 hours post dosing
    - Change in PEF at 24 hours post dose from baseline
    - FEV1 % max
    - Baseline adjusted AUC of FEV1% from 0 to 24 hours post dosing
    - Change in FEV1% at 24 hours post dose from baseline
    - FVC max
    - Baseline adjusted AUC of FVC from 0 to 24 hours post dosing
    - Change in FVC at 24 hours post dose from baseline
    - Partial baseline adjusted AUC for FEV1 from 0 to 4 hours post dose
    - Partial baseline adjusted AUC for FEV1 from 4 to 8 hours post dose
    - Partial baseline adjusted AUC for FEV1 from 8 to 12 hours post dose
    - Partial baseline adjusted AUC for FEV1 from 12 to 24 hours post dose
    Safety endpoints:
    - Adverse events
    - Physical examination
    - Vital signs
    - 12-lead ECG data
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1-Visit 2-Visit 3-Visit 4
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Partially blinded
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    North Macedonia
    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 months6
    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 months6
    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 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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 66
    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)
    NONE
    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 Decision2020-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-21
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