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    Summary
    EudraCT Number:2006-002289-21
    Sponsor's Protocol Code Number:CQAE397A2202
    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:2006-05-31
    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 number2006-002289-21
    A.3Full title of the trial
    An open label study to assess the utility of measuring markers of inflammation, to detect transition from optimal to sub-optimal Inhaled corticosteroid therapy in moderatesevere bronchial asthma
    A.4.1Sponsor's protocol code numberCQAE397A2202
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 nameFlutide® 250 Diskus®
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate severe bronchial asthma
    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
    To assess the change in inflammatory parameters in response to a decrease in inhaled ICS compared to no change in therapy after 2 and 4 weeks
    E.2.2Secondary objectives of the trial
    • To identify which parameter/combination of parameters is most sensitive to the steroid reduction
    • To provide sufficient data to assess sample size calculations for subsequent studies
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.

    2. Diagnosis of Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months. No concomitant lung disease or significant medical conditions that would affect the subjects’ safety from participating in the study, or that would be expected to impact on the result from the study.

    3. Fluticasone propionate 500mcg daily or greater, or equivalent (Mometasone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg,
    Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg)

    4. FEV1 at screening will be ≥ 70% of the normal predicted FEV1.

    5. Evidence of asthma, demonstrated by one of the following:
    Historical evidence confirmed by their treating physician.
    or
    Demonstration of ≥ 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes. This criterion for FEV1 will have to be demonstrated
    after a washout period of at least 6 h during which no short-acting β2-agonist has been inhaled, or longer as required for long-acting β2-agonist.
    or
    Documented bronchial hyper-reactivity to (≤8 mg/mL) metacholine or histamine
    challenge.

    6. Female subjects of child bearing potential must be using two forms of contraception,
    either double-barrier local contraception, i.e. intra-uterine device plus condom, or
    spermicidal gel plus condom, or the contraceptive pill plus condom.
    or:
    Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior
    to inclusion. Menopause will be confirmed by laboratory tests.

    7. Body Mass Index between 18 and 30. Body weight should be less than 100 kg.

    8. Able to provide written informed consent prior to study participation.
    9. Able to communicate well with the investigator and comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. Smokers with a history of tobacco use greater than 10 pack years (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports cigarette use.

    2. Concomitant medications:
    • Except for short acting β2-agonists for symptom relief and long acting β-agonists (in
    case this was part of patients usually prescribed medication) medication associated
    with study procedures and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. A washout period of 3 months is required for previous administration of any biologic therapy. The following wash-out periods should be adhered to for asthma treatments:
    • Increase in Inhaled steroid use: 6 weeks before study start and during study.
    • Oral steroids: 8 weeks before study and during study.
    • Topical steroids: 4 weeks before study and during study (of if not possible, dose
    should remain constant for the two weeks before and during the study).
    • Antileukotrienes: 4 weeks before study start and during study.
    • Antihistamines/cromoglycates: 4 weeks and during study.
    • Theophyllin: 4 weeks before and during study.

    3. Medical conditions:
    • history of clinically significant drug allergy;
    • any significant medical condition that in the opinion of the Investigator may
    compromise subject safety, subject compliance, interfere with evaluations, or
    preclude completion of the trial. For example, a history of any pulmonary disorder
    other than asthma.

    4. Any surgical or medical condition which might significantly alter the distribution,
    metabolism or excretion of the drug.
    5. Participation in any clinical investigation within 4 weeks prior to dosing or longer if
    required by local regulation.
    6. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
    7. Significant illness within the two weeks prior to dosing.
    8. A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
    9. History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus
    arrhythmia).
    10. A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone
    propionate.
    11. History of immunocompromise, including a positive HIV test result.
    12. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    13. History of drug or alcohol abuse within the 12 months prior to dosing
    E.5 End points
    E.5.1Primary end point(s)
    FEV1 is measured at screening (Visit 1), Baseline (Visit 2), Visit 3 and Study Completion (Visit 4).

    Peak Expiratory Flow Rate (PEF):
    Morning PEF will be measured daily during the whole study period.

    Exhaled nitric oxide [ppb] will be assessed by using the Nioxx - analyzer (Aerocrine, Sweden) at a flow rate of 50 ml/sec. This measurement will be performed Visits 2, 3 & 4.

    Bronchial Hyperreactivity (PC20)

    Differential cell counts in blood samples (eosinophils) and sputum (see protocol for details)
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Monitoring of markers (inflammation)
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Continuation of previously prescribed therapy (SABA, ICS +/- LABA)
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Last Patient Last Visit
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2006-05-31. 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 26
    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 Decision2006-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-08
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