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    Summary
    EudraCT Number:2005-004543-57
    Sponsor's Protocol Code Number:D9618C00001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-004543-57
    A.3Full title of the trial
    A 6-month randomized, double-blind, parallel-group, multicentre, placebo-controlled Phase II study to compare anti-asthmatic effect and safety of esomeprazole (Nexium) 40 mg twice daily or 40 mg once daily with placebo in adults with asthma
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberD9618C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameEsomeprazole
    D.3.2Product code (Nexium)
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNesomeprazole magnesium trihydrate
    D.3.9.1CAS number 217087-09-7
    D.3.9.2Current sponsor codeH199_18
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboGastro-resistant capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD)
    MedDRA Classification
    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 of this study is to compare the anti-asthmatic effect of esomeprazole, given either as 40 mg twice daily or 40 mg once daily, with that of placebo in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease (GERD) by evaluation of change in morning Peak Expiratory Flow (mPEF) from baseline (mean ofthe last 7 days in the run-in period) to treatment period (mean of all available data during the treatment period) as the primary outcome variable.
    E.2.2Secondary objectives of the trial
    Investigate the effect on symptoms of GERD when treating adult patients having moderate to severe asthma and symptoms of GERD with esomeprazole 40 mg twice daily or 40 mg once daily or placebo by evaluation of change in symptoms of GERD as measured by Reflux Disease Questionnaire (RDQ) Assess the safety and tolerability of the treatments esomeprazole 40 mg twice daily and 40 mg once daily for 6 months.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    For inclusion in the study run-in period the patient must fulfil all of the following criteria at Visit 2:
    1. Provision of written informed consent.
    2. Female or male aged 18 to 70 years inclusive.
    3. Clinical diagnosis of asthma as defined by the ATS definition, for at least 6 months prior to Visit 2.
    4. A reversibility in FEV1 of at least 12% and ≥0.20 L from baseline after inhalation
    of 2 x 0.5 mg terbutaline (Bricanyl® Turbuhaler®) or 2 x 0.2 mg albuterol via a pressurized metered dose inhaler (pMDI).
    5. Daily use of inhaled GCS and LABA for ≥3 months prior to Visit 2.
    6. A history of at least one clinically important asthma exacerbation, as judged by the investigator, between 1 to 12 months prior to Visit 2.
    7. A history of at least 3 months of 1 or more of the 3 GERD symptoms listed in inclusion criterion no 8.
    8. Symptoms or history of GERD. According to scores in patient’s self-reported RDQ at least 1 of the following GERD symptoms must have a frequency of ≥ 2 days during the last week and at least 1 symptom must be of at least moderate severity:- a burning feeling behind the breastbone - pain behind the breastbone - an acid taste in the mouth - or patient must have a documented history of an abnormal esophageal 24-hourpH monitoring up to 3 years prior to Visit 2, measured by catheter basedor catheter free (BRAVO®) techniques according to the manufacturer’s instruction. The limit of percentage time of pH<4, assessed as pathological esophageal acid exposure, should be the same as the local references for respective technique.

    To be randomized to the treatment period, the following criteria must be fulfilled at Visit 3:

    1. Run-in diary data for at least 7 of the last 10 days of the run-in period.
    2. Mean mPEF during the last 7 days of the run-in period of 50-85% of postbronchodilatory PEF.
    3. Total intake of the supplied rescue medication must not exceed an acid-binding capacity of 100 mmol HCl/day during the run-in period.
    4. Total asthma symptom score (night-time plus daytime) of ≥ 1 on at least 4 of the last 7 days of the run-in period.
    5. Symptoms of GERD during run-in. According to scores in patient’s self-reported RDQ at least 1 of the symptoms must have a frequency of ≥ 2 of the last 7 days ofthe run-in period and at least 1 symptom must be of at least moderate severity:
    - a burning feeling behind the breastbone - pain behind the breastbone - an acid taste in the mouth.
    E.4Principal exclusion criteria
    1. Patients with clinically relevant abnormalities at Visit 2 (ECG, vital signs, physical examination, or laboratory values), as judged by the investigator.
    2. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or patient’s ability to participate in the study.
    3. Patients with alarm symptoms such as unintentional weight loss, haematemesis, jaundice, dysphagia, or any other sign indicating serious or malignant disease.
    4. Patients with a smoking history of ≥10 pack-year (ie, equivalent of smoking 20 cigarettes per day for 10 years).
    5. Use of oral, rectal, or parenteral GCS within 30 days prior to Visit 2.
    6. Patients > 50 years of age with GERD symptoms according to inclusion criterion
    no 8 who have not been investigated (x-ray of upper gastrointestinal tract or endoscopy) within 1 year prior to Visit 2 to exclude upper gastrointestinal tract malignant disease.
    7. Patients who have had previous surgery on the esophagus or the stomach.
    8. Patients with endoscopy-verified erosive esophagitis within the last 16 weeks priorto Visit 2 or Barrett’s esophagus with associated dysplasia.
    9. Pregnancy or breast-feeding. Fertile women without acceptable contraceptive measures, as judged by the investigator.
    10. Patients with a known hypersensitivity to any component of any PPI: esomeprazole,omeprazole, lansoprazole, rabeprazole, pantoprazole, or tenatoprazole.

    Any of the following is regarded as a criterion for exclusion from the study at Visit 3:
    17. A decrease in FEV1 >20% from Visit 2 and/or FEV1 <45% of the predicted normal value.
    18. A clinically important asthma exacerbation, as judged by the investigator, during the run-in period.
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary endpoint in this study

    The primary outcome variable: Change in mPEF from baseline to treatment period.
    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 Information not present in EudraCT
    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 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.8.3 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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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) Yes
    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 2006-02-06. 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 730
    F.4.2.2In the whole clinical trial 1100
    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 Decision2006-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-21
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