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    Summary
    EudraCT Number:2005-005616-25
    Sponsor's Protocol Code Number:205.342
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-005616-25
    A.3Full title of the trial
    A 16-week randomised, placebo-controlled, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of tiotropium inhalation solution delivered by the Respimat inhaler 2 puffs of 2.5 mcg once daily with that of salmeterol from the hydrofluoroalkane metered dose inhaler 2 puffs of 25 mcg twice daily in moderate persistent asthma patients homozygous for B16-Arg/Arg.
    A.3.2Name or abbreviated title of the trial where available
    Tiotropium Salmeterol Study in asthma
    A.4.1Sponsor's protocol code number205.342
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBOEHRINGER ING.
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 bromide inhalation solution
    D.3.2Product code Ba 679 BR
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 136310-93-5
    D.3.9.2Current sponsor codeBa 679 Br
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Serevent Evohaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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
    D.3.9.1CAS number 136310-93-5
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboPressurised inhalation, solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, suspension
    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
    Patients with moderate persistent bronchial asthma and homozygous for arginine at the 16th position of the beta-2-adrenergic receptor
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy and safety of tiotropium inhalation solution 5 mcg 2 puffs of 2.5 mcg once daily delivered by the Respimat inhaler with that of salmeterol HFA MDI 50 mcg 2 puffs of 25 mcg twice daily in moderate persistent asthmatic patients homozygous for B16-Arg/Arg.
    E.2.2Secondary objectives of the trial
    Efficacy -Daily morning and evening peak expiratory flow pre-dose, weekly means -Peak expiratory flow variability the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values, weekly means -Daily morning and evening FEV1 pre-dose, weekly means -Daily diary on asthma control questionnaire on asthma symptoms and use of as needed rescue medication -Morning pre-dose FEV1 and morning pre-dose FVC on study visits -Mini-Asthma Quality of Life Questionnaire Mini AQLQ on study visits -Number of patients with at least one exacerbation of asthma Safety -Vital signs pulse, blood pressure on study visits -Laboratory investigations at visit 1 -Physical examination and 12-lead ECG at visit 1 and end of study -Adverse events
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Patients must be homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor B16 Arg/Arg . 2.All patients must sign and date an Informed Consent Form for the study consistent with ICH-GCP guidelines and local legislation prior to participation in the trial 3.Male or female outpatients with at least 18 years of age, but not older than 60 years 4.Patients must have a documented history of asthma 5.Patients must be current non-smokers or ex-smokers with a cigarette smoking history of 10 pack-years and smoking cessation at least one year prior to study enrolment 6.All patients must be on a maintenance treatment with inhaled corticosteroids alone or in a fixed combination with a LABA or a SABA with a total daily dose of 400 - 1000 mcg budesonide or equivalent within the last 3 months and with a stable dose within the last 3 weeks prior to visit 1 7.Two groups of patients are eligible for this study depending on their LABA pre-treatment Patients who are on a maintenance treatment with LABAs with a total daily dose of at least 100 mcg salmeterol or at least 18 mcg formoterol within the last 3 months and a stable dose within the last 3 weeks prior to visit 1 are eligible if they meet the following spirometric criterion Pre-bronchodilator FEV1 90 of predicted normal at visit 1 Patients who have not been treated with LABAs within the last year before visit 1 are eligible if they meet the following spirometric criterion Pre-bronchodilator FEV1 80 of predicted normal at visit 1 Predicted normal values will be calculated according to ECSC 8.Reversibility of airways obstruction must be demonstrated by a reversibility test with ipratropium and salbutamol at visit 1. Patients inhale 4 puffs 80 mcg ipratropium from the MDI, PFT by spirometry is performed pre-dose first PFT and 45 minutes after ipratropium administration second PFT , then patients inhale 4 puffs 400 mcg from the salbutamol MDI and PFT is performed again 30 minutes after salbutamol administration third PFT . Patients must demonstrate an increase in FEV1 of at least 12 and 200 mL from the pre-dose PFT to the second PFT or from the pre-dose PFT to the third PFT. 9.Patients must be able to perform technically acceptable pulmonary function tests and Peak flow measurements with the electronic peak flow meter and must be able to perform all necessary recordings in the electronic diary as part of the electronic peak flow meter Asthma Monitor . 10.Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler MDI .
    E.4Principal exclusion criteria
    1.Patients with a significant disease other than asthma. 2.Patients with recent history i.e., six months or less of myocardial infarction 3.Patients who have been hospitalized for heart failure NYHA class III or IV within the past year 4.Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 5.Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 6.Patients with a diagnosis of chronic obstructive pulmonary disease COPD 7.Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis 8.Patients with known active tuberculosis 9.Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1. 10.Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study. 11.Patients who are being treated with beta-blocker medication. Cardio-selective beta-blocker eye medication for treatment of non-narrow angle glaucoma are allowed. 12.Patients who have been treated with the long-acting anticholinergic tiotropium Spiriva within 4 weeks prior to visit 1 13.Patients who were treated with cromolyn sodium or nedocromil sodium within 2 weeks prior to visit 1 14.Patients who were treated with oral betamimetics within 2 weeks prior to visit 1 15.Patients who were treated with oral corticosteroids within 4 weeks prior to visit 1 16.Patients who were treated with theophylline within 2 weeks prior to visit 1 17.Patients who were treated with leucotriene modifiers within 4 weeks prior to visit 1 18.Patients who were treated with omalizumab within 4 weeks prior to visit 1 19.Patients with known hypersensitivity to anticholinergic drugs or any other components of the inhalation solution used in the Respimat inhaler 20.Patients with known hypersensitivity to salmeterol xinafoate or any other components of the salmeterol MDI 21.Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are of child-bearing potential and are not practicing acceptable means of birth control mechanical and/or chemical . 22.Patients who have taken an investigational drug within one month or six half lives whichever is greater prior to visit 1 23.Patients with previous participation receipt of randomised treatment in this study 24.Patients who are currently participating in another study 25.Patients with significant alcohol or drug abuse within the past two years 26.Patients with any respiratory tract infection or exacerbation in the four weeks prior to visit 1 or during the run-in period. 27.Patients requiring more than 12 puffs of rescue medication salbutamol MDI per 24 hours on 3 consecutive days during the run-in period should not be randomised
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of this study is the change in mean weekly morning peak expiratory flow from baseline to the last week of treatment. Baseline is defined as the last week prior to randomisation visit.
    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 Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-08-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1750
    F.4.2.2In the whole clinical trial 2500
    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 Decision2006-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-01
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