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    Summary
    EudraCT Number:2005-004543-57
    Sponsor's Protocol Code Number:D9618C00001
    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:2006-03-08
    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 number2005-004543-57
    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 NexiumTR 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
    RELAX STUDY
    A.4.1Sponsor's protocol code numberD9618C00001
    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 SponsorASTRAZENECA
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NEXIUM 40MG14CPR GASTR.BL
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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
    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
    Sub-optimally controlled moderate to severe asthma and symptoms of GERD.
    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 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 of the 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
    - To 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 - To 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
    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 Expert Panel Report 2 1997 for at least 6 months prior to Visit 2. 4. A reversibility in FEV1 of at least 12 and 8805;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 8805;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 ie, not within the last 30 days 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 8805; 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-hour pH monitoring up to 3 years prior to Visit 2, measured by catheter based or catheter free BRAVO techniques according to the manufacturer s instruction. The limit of percentage esophageal acid exposure, should be the same as the local references for respective technique.
    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 eg, cardiovascular, pulmonary other than asthma , gastrointestinal other than GERD , liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment 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 8805;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 prior to 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. Fertile women are defined as women of child-bearing potential from first menstruation to 1 year after last menstruation. Acceptable methods of birth control include contraceptive patch, intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive started at least 1 month prior to Visit 2 and continuing for the duration of the study , or condoms with spermicide, tubal ligation, and double-barrier methods. Single-barrier methods alone and rhythm methods are not acceptable methods of birth control. 10. Patients with a known hypersensitivity to any component of any PPI esomeprazole,omeprazole,lansoprazole, rabeprazole, pantoprazole, or tenatoprazole. 11. Planned donation of blood during the study. 12. Planned hospitalisation during the study. 13. Suspected poor capability, as judged by the investigator, of following instructions of the study, eg, because of alcohol or drug abuse, or any other reason. 14. Participation in another clinical study of any investigational drug within 30 days prior to Visit 2 or during the study. 15. Previous randomization in the present study. 16. Involvement in the planning and conduct of the study applies to both AstraZeneca staff and staff at the study site .
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Primary outcome variable Change in mPEF from baseline mean of the last 7 days during the run-in period to treatment period mean of all available data during the 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 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 Yes
    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 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 years2
    E.8.9.1In the Member State concerned months1
    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 2006-03-08. 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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 685
    F.4.2.2In the whole clinical trial 1015
    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 Decision2006-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-21
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