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    Summary
    EudraCT Number:2014-002590-10
    Sponsor's Protocol Code Number:P130906
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-002590-10
    A.3Full title of the trial
    Effect of bronchodilators on effort induced dyspnoea in patients suffering
    lung hypertension
    Effets des bronchodilatateurs sur la dyspnée induite par l’effort physique chez les patients atteints d’HyperTension Artérielle Pulmonaire (HTAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of bronchodilators on effort induced dyspnoea in lung hypertension patients
    Effet des bronchodilatateurs sur la dyspnée d'effort chez les patients présentant une hypertension pulmonaire
    A.3.2Name or abbreviated title of the trial where available
    BD-HTAP
    A.4.1Sponsor's protocol code numberP130906
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-maildidier.bouton@aphp.fr
    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 Bromure d'Ipratropium
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameBromure d'Ipratropium
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    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 INNBromure d'Ipratropium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5mg/2ml
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    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 No
    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 Salbutamol
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSalbutamol
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalbutamol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5mg/2.5ml
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    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 No
    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 placeboInhalation vapour, liquid
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic or heritable patients with pulmonary arterial hypertension (PAH).
    Idiopathic or heritable patients with pulmonary arterial hypertension (PAH).
    E.1.1.1Medical condition in easily understood language
    Lung arterial hypertension
    Hyper tension artérielle pulmonaire
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that administration of inhaled BDs (?2-agonist and/or anticholinergic), as add-ons to vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of onset of DH-induced critical ventilatory constraints, thus ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.
    To test the hypothesis that administration of inhaled BDs (?2-agonist and/or anticholinergic), as add-ons to vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of onset of DH-induced critical ventilatory constraints, thus ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.
    E.2.2Secondary objectives of the trial
    Difference (BD versus placebo) in CWR endurance time (60 seconds difference) will be also evaluated as potential index of improved exercise tolerance (secondary evaluation criterion).
    Difference (BD versus placebo) in CWR endurance time (60 seconds difference) will be also evaluated as potential index of improved exercise tolerance (secondary evaluation criterion).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Idiopathic or heritable PAH patients, clinically stable during the 3 preceding months, non/never smokers, with normal FEV1/VC ratio but FEF75% ? 60% predicted.
    Idiopathic or heritable PAH patients, clinically stable during the 3 preceding months, non/never smokers, with normal FEV1/VC ratio but FEF75% ? 60% predicted.
    E.4Principal exclusion criteria
    1. Pregnant women
    2. Past or current tobacco-smoking history,
    3. A spirometric evidence of an obstructive ventilatory defect as defined by a reduced FEV1/VC ratio below the 5th percentile of the predicted value [43],
    4. A FEF75% >60% of predicted normal values at spirometry,
    5. A TLC below the 5th percentile of the predicted value [43],
    6. A body mass index >30 kg.m-2,
    7. Use of supplemental oxygen,
    8. PAH induced by drugs and toxins,
    9. PAH associated with other conditions, including connective tissue diseases, congenital heart diseases, portal hypertension, and HIV infection [42],
    10. Chronic thromboembolic pulmonary hypertension [42],
    11. Other respiratory, cardiac and other diseases that could contribute to dyspnoea or exercise limitation,
    12. Contraindications to clinical exercise testing, such as NYHA functional class IV, syncope and others, as detailed page 28 elsewhere [26, 44].
    1. NYHA functional class IV
    2. Syncope
    3. Acute myocardial infarction (3-5 days)
    4. Unstable angina
    5. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
    6. Uncontrolled heart failure
    7. Active endocarditis
    8. Acute myocarditis or pericarditis
    9. Symptomatic severe aortic stenosis
    10. Suspected dissecting aneurysm
    11. Acute pulmonary embolus or pulmonary infarction
    12. Thrombosis of lower extremities
    13. Uncontrolled asthma
    14. Pulmonary edema
    15. Room air desaturation at rest <85%
    16. Respiratory failure
    17. Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
    18. Mental impairment leading to inability to cooperate

    Relative Contraindications to clinical exercise testing:
    Specific precision for exclusion criteria n°12: Absolute Contraindications to clinical exercise testing:
    1. Left main coronary stenosis or its equivalent
    2. Moderate stenotic valvular heart disease
    3. Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
    4. Tachyarrhythmias or bradyarrhythmias
    5. High-degree atrioventricular block
    6. Hypertrophic cardiomyopathy
    7. Electrolyte abnormalities
    8. Orthopedic impairment that compromises exercise performance
    13. Specific contraindications (precautions and drug interactions) to the administration of IB or IB+SALB (please refer to section 7).
    1. Pregnant women
    2. Past or current tobacco-smoking history,
    3. A spirometric evidence of an obstructive ventilatory defect as defined by a reduced FEV1/VC ratio below the 5th percentile of the predicted value [43],
    4. A FEF75% >60% of predicted normal values at spirometry,
    5. A TLC below the 5th percentile of the predicted value [43],
    6. A body mass index >30 kg.m-2,
    7. Use of supplemental oxygen,
    8. PAH induced by drugs and toxins,
    9. PAH associated with other conditions, including connective tissue diseases, congenital heart diseases, portal hypertension, and HIV infection [42],
    10. Chronic thromboembolic pulmonary hypertension [42],
    11. Other respiratory, cardiac and other diseases that could contribute to dyspnoea or exercise limitation,
    12. Contraindications to clinical exercise testing, such as NYHA functional class IV, syncope and others, as detailed page 28 elsewhere [26, 44].
    1. NYHA functional class IV
    2. Syncope
    3. Acute myocardial infarction (3-5 days)
    4. Unstable angina
    5. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
    6. Uncontrolled heart failure
    7. Active endocarditis
    8. Acute myocarditis or pericarditis
    9. Symptomatic severe aortic stenosis
    10. Suspected dissecting aneurysm
    11. Acute pulmonary embolus or pulmonary infarction
    12. Thrombosis of lower extremities
    13. Uncontrolled asthma
    14. Pulmonary edema
    15. Room air desaturation at rest <85%
    16. Respiratory failure
    17. Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
    18. Mental impairment leading to inability to cooperate

    Relative Contraindications to clinical exercise testing:
    Specific precision for exclusion criteria n°12: Absolute Contraindications to clinical exercise testing:
    1. Left main coronary stenosis or its equivalent
    2. Moderate stenotic valvular heart disease
    3. Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
    4. Tachyarrhythmias or bradyarrhythmias
    5. High-degree atrioventricular block
    6. Hypertrophic cardiomyopathy
    7. Electrolyte abnormalities
    8. Orthopedic impairment that compromises exercise performance
    13. Specific contraindications (precautions and drug interactions) to the administration of IB or IB+SALB (please refer to section 7).
    E.5 End points
    E.5.1Primary end point(s)
    primary endpoint: ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.

    secondary endpoint: potential index of improved exercise tolerance (secondary evaluation criterion).
    primary endpoint: ameliorating the exertional symptoms in patients with stable PAH undergoing high-intensity constant work-rate (CWR) cycle endurance test.

    secondary endpoint: potential index of improved exercise tolerance (secondary evaluation criterion).
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    dernier visite du dernier patient
    E.5.2Secondary end point(s)
    Change (increase) of at least 60 seconds in CWR-CPET endurance time between pre-dose and post-dose BD measured at the end of CWR bouts. This criterion will be used to evaluate the potential improvement in exercise tolerance.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSLV
    dernière visite du dernier patient
    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 No
    E.6.5Efficacy No
    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.6.13.1Other scope of the trial description
    NA
    NA
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sérum physiologique
    Physiological serum
    E.8.2.4Number of treatment arms in the trial3
    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
    LSLV
    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 months4
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 2016-03-02. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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)
    NA
    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 Decision2016-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-24
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