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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-001387-39
    Sponsor's Protocol Code Number:1.4
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-001387-39
    A.3Full title of the trial
    A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
    Der Einfluss der langzeitigen Sauerstoff-Therapie auf den 6-Min-Gehtest, die hämodynamischen und klinischen Parametern bei Patienten mit pulmonal-arterieller Hypertonie (PAH) / chronisch-thromboembolischer pulmonaler Hypertonie (CTEPH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of oxygen therapy in patients with pulmonary Hypertension.
    Effekt von Sauerstofftherapie bei Patienten mit Lungenhochdruck
    A.3.2Name or abbreviated title of the trial where available
    SOPHA
    A.4.1Sponsor's protocol code number1.4
    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 SponsorThoraxklinik-Heidelberg gGmbH
    B.1.3.4CountryGermany
    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 supportVitalAire GmbH and OMT GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThoraxklinik Heidelberg gGmbH
    B.5.2Functional name of contact pointCentre for pulmonary hypertension
    B.5.3 Address:
    B.5.3.1Street AddressRöntgenstr. 1
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69126
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962213968076
    B.5.5Fax number+4962213961209
    B.5.6E-mailPH-Studies.THOR@med.uni-heidelberg.de
    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 Oxygen, liquid
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 vapour, liquid
    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 INNOXYGEN
    D.3.9.3Other descriptive nameSauerstoff
    D.3.9.4EV Substance CodeSUB14733MIG
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pulmonary arterial hypertension (PAH) and chronic thromboembolic
    pulmonary hypertension (CTEPH)
    pulmonal-arterielle Hypertonie (PAH) chronisch-thromboembolische
    pulmonale Hypertonie (CTEPH)
    E.1.1.1Medical condition in easily understood language
    Patients with pulmonary Hypertension
    Patienten mit Lungenhochdruck
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during ≥16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD)
    E.2.2Secondary objectives of the trial
    1) To investigate effects of oxygen treatment on QoL, measured with SF-36 questionnaire 2) To determine the hemodynamic and functional responses during long term oxygen treatment by echocardiography and right heart catheterisation 3) To investigate the change of clinical parameters such as blood gas analysis, laboratory (NT-proBNP), WHO functional class (WHO-FC) 4) To assess time to worsening of oxygen saturation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients in both groups (n = 40) with precapillary PH, WHO class I -IV (mPAP ≥ 25 mm Hg, pulmonary arterial occlusion pressure ≤15 mm Hg), who are stable on optimized pharmacological treatment for at least six weeks and who do not suffer from other cardio-pulmonary disease will be recruited if arterial or capillary O2 partial pressure is repeatedly (<60 mmHg; alternatively, 90% of O2 saturation) at rest and during physical activity hypoxemia still persist (O2 partial pressure <60 mmHg SpO2 90 % ). - men and women 18 years of age or older - patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1-3 (by the WHO Clinical classification system)), including Idiopathic (IPAH), Heritable PAH (HPAH, Familial PAH), and CTEPH, with exceptions as noted in exclusion criteria - patient (or patient's legally authorized representative) is willing and able to provide written informed consent - patient is willing and able to comply with the protocol, including required follow-up visits - Patient experiences oxygen desaturations below 90% (or pO2 below 60 mmHg) at rest with oxygen desaturations below 90% (or pO2 below 60 mmHg) during physical activity - patient has a stable functional class of PAH with no changes of medication during the last six weeks before inclusion
    E.4Principal exclusion criteria
    - Patient is a female who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control - patient has already been treated with long-term oxygen therapy within the last 3 weeks. - patient with pulmonary venous hypertension - significant functional limitation in lung function tests (FEV1>60%,TLC <60%) and CT morphological signs of pulmonary disease - significant left heart disease, requires acute pharmacological or interventional treatment - unstable conditions requiring pharmacological or other treatment, intensive care or relevant severe concomitant disease - patient is enrolled, has participated within the last thirty days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrolment in concurrent trials is only allowed with documented pre-approval from the study manager that there is not a concern that co-enrolment could confound the results of this trial. - patient has been initiated on a new oral or parenteral PAH therapy in the last two months - patient has had a recent (within three months) or otherwise unresolved infection requiring antibiotic treatment - patient with a cardiac index (CI) <1.8L/min/m2 - patient is Functional Class IV (New York Heart Association (NYHA)) active smoking status - patient with severe resting desaturation (repeatedly SpO2 ≤85%) or severe exercise-induced desaturation (SpO2 <80% for ≥10 minutes)
    E.5 End points
    E.5.1Primary end point(s)
    To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during ≥16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after treatment start with or without oxygen
    E.5.2Secondary end point(s)
    - To investigate effects of oxygen treatment on QoL, measured with SF-36 questionnaire - To determine the hemodynamic and functional responses during long term oxygen treatment by echocardiography and right heart catheterisation - To investigate the change of clinical parameters such as blood gas analysis, laboratory (NT-proBNP), WHO functional class (WHO-FC) - To assess time to worsening of oxygen saturation and time to clinical worsening
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks after treatment start with or without oxygen
    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 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 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 No
    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
    treatment without oxygen
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 state40
    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)
    After the end of the study it is up to the judgment of the investigator to prescribe oxygen to all patients who might benefit from the treatment.
    This decision will be based on the physician's and the patient's
    estimation taking into account the observed individual treatment
    effect, progression of disease, patient view and any comments from the Ethics Committee, if applicable. Patient care and monitoring will be performed in the patients' specialized Centers.
    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 Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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