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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-001996-39
    Sponsor's Protocol Code Number:A2171069
    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:2006-05-24
    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 number2006-001996-39
    A.3Full title of the trial
    AN INTERNATIONAL, MULTICENTER, LARGE SIMPLE TRIAL (LST) TO EVALUATE THE LONG-TERM PULMONARY AND CARDIOVASCULAR SAFETY OF EXUBERA® IN PATIENTS WITH DIABETES MELLITUS
    A.3.2Name or abbreviated title of the trial where available
    Large Simple Trial (LST)
    A.4.1Sponsor's protocol code numberA2171069
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    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 SponsorPfizer Pharma GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Exubera®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNInsulin Human
    D.3.9.2Current sponsor codeCP-464-005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 Yes
    D.2.1.1.1Trade name Exubera®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNInsulin Human
    D.3.9.2Current sponsor codeCP-464-005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Diabetes Mellitus Type I and Type II
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Original Protocol:
    The primary objective of this study is to estimate the relative risk of a persistent decline in forced expiratory volume in one second (FEV1) exceeding 20% from baseline among subjects with diabetes randomized to Exubera as compared with those not randomized to Exubera. For both treatment groups, a persistent decline in FEV1 exceeding 20% from baseline is defined as an observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline in FEV1 exceeding 20% from baseline.

    Amendment April 2008:
    Unless unanticipated large effects emerge, the study will be underpowered to address the primary endpoint. However, the study data will still provide important descriptive information. Assuming the primary and secondary endpoints are underpowered, the risk of each endpoint will be estimated (and have corresponding 95% confidence intervals provided) among subjects randomized to Exubera® and subjects randomized to non-Exubera®.
    E.2.2Secondary objectives of the trial
    Original Protocol:
    The secondary objectives are to compare subjects randomized to Exubera to those not randomized to Exubera to estimate the relative: (1) risk of pulmonary serious adverse event (SAE) composite, including: SAEs of asthma, chronic obstructive pulmonary disease (COPD), pneumonia, or acute bronchitis, (2) risk of all-cause mortality, (3) risk of cardiovascular SAE composite, including: SAEs of cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke, (4) risk of allergic response SAE composite, including: SAEs of anaphylaxis, angioedema, generalized allergic reaction, and allergic bronchospasm, and (5) change in HbA1c from baseline at month 6, and years 1, 2, 3, 4 and 5.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Eligible for receiving Exubera treatment based on the approved local label.
    2. 18 years or older
    3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial has been obtained by the enrolling physician
    4. The subject is willing to provide information on at least one alternate contact person for study staff to contact regarding subjects whereabouts, should the subject be lost-to-follow- up over the course of the study
    5. The subject is willing and able to comply with scheduled visits, pulmonary function
    testing, and laboratory tests
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Pregnant or lactating
    2. Have a progressive fatal disease or a life expectancy that prohibits them from
    participating in a five-year research study
    3. Have a medical or psychological condition that would prevent completion of a five-year study
    4. Have participated in any other studies involving study drugs within 30 days prior to entry in the study
    5. Previously enrolled in this study
    E.5 End points
    E.5.1Primary end point(s)
    For this study, all subjects are required to undergo spirometric tests to measure pulmonary function according to the approved local label; at baseline, 6 months, 1 year and then yearly thereafter for a total duration of 5 years. If during any follow-up visit known to the enrolling physician a FEV1 decline from baseline exceeding 20% is observed, a confirmatory spirometry test must be performed 3-4 weeks later. If the confirmatory spirometry verifies a decline in FEV1 from baseline exceeding 20%, Exubera therapy must be discontinued in subjects treated with Exubera (per the SmPC/USPI), and the subject should undergo another follow-up spirometry in 3 months.

    A persistent decline in FEV1 exceeding 20% at the 3-month follow-up spirometry, deems the subject to have reached the primary endpoint (see Study Design Flowchart in Appendix 1.2 of the protocol). When a subject reaches the primary endpoint, he/she should be referred to a pulmonologist.

    Several secondary endpoints will also be evaluated: (1) pulmonary serious adverse event (SAE) composite, including: SAEs of asthma, COPD, pneumonia, or acute bronchitis, (2) all-cause mortality, (3) cardiovascular SAE composite, including: SAEs of cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke, (4) allergic response SAE composite, including: SAEs of anaphylaxis, angioedema, generalized allergic reaction, and allergic bronchospasm, and (5) change in HbA1c from baseline at month 6, and years 1, 2, 3, 4 and 5 (see Appendix 1.3 of the protocol).
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Usual diabetes care
    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.8.4.1Number of sites anticipated in Member State concerned44
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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 Yes
    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 months8
    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 months8
    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 Yes
    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 2006-05-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject' incapable of giving consent may participate - consent may be given by a
    legally acceptably representative (see protocol).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2740
    F.4.2.2In the whole clinical trial 5300
    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)
    While there are no plans to treat or care for subjects after their participation ends, under the amended protocol, subjects will be followed for 6 months for serious adverse events after the last required visit. During the last visit, the last scheduled spirometry and transition to usual care will take place.
    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 Decision2006-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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