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    Summary
    EudraCT Number:2006-004045-42
    Sponsor's Protocol Code Number:VPI-102-05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004045-42
    A.3Full title of the trial
    Randomized, Open-Label, Active Controlled, Two-Period Crossover Study To Evaluate Relative Efficacy And Safety of Investigational Captisol-Enabled Budesonide Inhalation Solution (CBIS) Delivered via eFlow Nebuliser and Conventional Budesonide Inhalation Suspension (Pulmicort Respules) Delivered via LC Plus Jet Nebuliser in Adult Patients with Mild To Moderate Persistent Asthma
    A.3.2Name or abbreviated title of the trial where available
    Cross-Over Safety Study with CBIS in Mild to Moderate Astmatic Adult Patients
    A.4.1Sponsor's protocol code numberVPI-102-05
    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 SponsorVerus Pharmaceuticals Inc
    B.1.3.4CountryUnited States
    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 nameCaptisol-Enabled Budesonide
    D.3.2Product code CBIS
    D.3.4Pharmaceutical form Nebuliser 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.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333223
    D.3.9.2Current sponsor codeCBIS
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 No
    D.3.11.8Extractive medicinal product No
    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 Pulmicort Respules
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca UK Ltd
    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.3.1Product namePulmicort Respules
    D.3.4Pharmaceutical form Nebuliser 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 INNBUDESONIDE
    D.3.9.1CAS number 51333223
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of Captisol-Enabled Budesonide Inhalation Solution (CBIS) delivered via an electronic nebuliser (eFlow, PARI, Munich, Germany) in asthmatic adults 16-60 years of age using clinical endpoints (heart rate, blood pressure), 12-hour overnight urinary cortisol, and adverse events after 2 weeks exposure.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of CBIS delivered via eFlow to conventional budesonide inhalation suspension (Pulmicort Respules) delivered via a general purpose nebuliser (LC Plus, PARI, Munich, Germany) using methacholine (MCH) challenge test, fractional exhaled nitric oxide (FeNO), clinical asthma symptoms and pulmonary function tests after twice daily treatments for 2 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age 16 to 60 years, inclusive, at the Screening Visit.
    2.Male or female (neither pregnant nor lactating). All female subjects must have a negative urine pregnancy test immediately prior to entry into the study and must be using an acceptable means of birth control.
    3.History of asthma for greater than or equivalent to 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms.
    4.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be less than or equal to 1000 mcg/day beclomethasone dipropionate or equivalent.
    5.History of FEV1 of > 60% of predicted normal values following appropriate withholding of inhaled beta-agonist and corticosteroid medication. Predicted FEV1 will be obtained by using the normal prediction equations of ERS
    6.Airway responsiveness to methacholine demonstrated by a provocation concentration causing 10% decrease in FEV1 (PC10) < 4 mg/mL at the Baseline Visit prior to entering Treatment Period 1.
    7.Demonstrate ability to use a peak flow meter.
    8.Meet two of the following criteria, as recorded by the subject during the Run-In Period on their Diary Cards, for 1 week immediately prior to the Baseline Visit/Treatment Period 1:
    a. Use of two or more puffs per day of rescue salbutamol for at least 3 days,
    b. One of the following asthma symptoms: at least one night with sleep disturbance, at least 3 days with asthma symptoms.
    9.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening.
    10.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent.
    11.Willing to discontinue current treatment and able to attend scheduled visits and complete the entire study.
    E.4Principal exclusion criteria
    1. History of life-threatening asthma. This category includes those subjects with a history of systemic corticosteroid treatment within 3 months of study entry or near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year.
    2. Current evidence or history of any clinically significant disease or abnormality. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
    3. History of concomitant lung disease.
    4. An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit.
    5. If more than 12 puffs of salbutamol, per day, are used.
    6. Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide or any medication.
    7. Receipt of an investigational drug within 30 days of the Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: The primary safety outcome is change in overnight urinary cortisol from baseline. The other safety variables will include the changes in vital signs, physical examination findings, and the incidence of treatment-emergent AEs during the Treatment Period.

    Efficacy: The primary efficacy outcome is change in PC10 from baseline (pooled value of post-Run-in and post-Washout Period values), following methacholine challenge. The other efficacy variables will include the changes in asthma symptom scores, pulmonary function tests, and airway and alveolar nitric oxide (FeNO).
    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 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 Yes
    E.7.1.3.1Other trial type description
    Proof of Concept
    E.7.2Therapeutic exploratory (Phase II) No
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    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.8.3 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 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
    The end of the trial will be the last visit of the last patient.
    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 months8
    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 months8
    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 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    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)
    Treatment or care after a subject has ended their participation in the trial will not be different from expected normal treatment of asthma
    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 Decision2006-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-22
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