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    Summary
    EudraCT Number:2014-003423-21
    Sponsor's Protocol Code Number:IK-7002-COPD-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-003423-21
    A.3Full title of the trial
    An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2).
    Een verkennend, tweedelige klinische studie om de effecten van gepulseerde, geïnhaleerde stikstofmonoxide (INO) te onderzoeken op functionele pulmonale beeldvorming parameters bij personen met Wereldgezonheidsorganisatie GROEP 3 pulmonale hypertensie (PH) geassocieerd met chronische obstructieve longziekte (COPD) die langdurige zuurstof therapie (LTOT) krijgen (Deel 1) en bij personen met Wereldgezonheidsorganisatie GROEP 3 pulmonale hypertensie (PH) geassocieerd met Idiopathische longfibrose (IPF) die langdurige zuurstof therapie (LTOT) krijgen (Deel 2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2).
    A.4.1Sponsor's protocol code numberIK-7002-COPD-006
    A.5.4Other Identifiers
    Name:CRO protocol code numberNumber:FLUI-2014-117
    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 SponsorBellerophon Pulse Technologies LLC
    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 supportBellerophon Pulse Technologies LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFluidda nv
    B.5.2Functional name of contact pointJan De Backer
    B.5.3 Address:
    B.5.3.1Street AddressGroeningenlei 132
    B.5.3.2Town/ cityKontich
    B.5.3.3Post code2550
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3234508720
    B.5.5Fax number+3234508729
    B.5.6E-mailjan.debacker@fluidda.com
    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 INOmax 400ppm mol/mol inhalation gas
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Healthcare AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameINO
    D.3.4Pharmaceutical form Pressurised inhalation
    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 INNNITRIC OXIDE
    D.3.9.1CAS number 10102-43-9
    D.3.9.2Current sponsor codeIK-7002
    D.3.9.4EV Substance CodeSUB12540MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.075
    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 Yes
    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 placeboPressurised inhalation
    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
    Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
    Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF)
    Deel 1: Pulmonale hypertensie (PH) geassocieerd met chronische obstructieve longziekte (COPD)
    Deel 2: Pulmonale hypertensie (PH) geassocieerd met Idiopathische longfibrose (IPF)
    E.1.1.1Medical condition in easily understood language
    Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
    Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF)
    Deel 1: Pulmonale hypertensie (PH) geassocieerd met chronische obstructieve longziekte (COPD)
    Deel 2: Pulmonale hypertensie (PH) geassocieerd met Idiopathische longfibrose (IPF)
    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 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10037401
    E.1.2Term Pulmonary hypertensions
    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
    The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of short term iNO administration using the medical device INOpulse® in subjects with WHO Group 3 PH associated with COPD (Part 1) and in subjects with WHO Group 3 PH associated with IPF (Part 2) on LTOT. In Part 1 iNO was administered by the investigational INOpulse® DS-C device. In Part 2 the INOpulse® device will be used.
    Het primaire doel van deze verkennende studie is het nut te onderzoeken van hoge resolutie computertomografie (HRCT) om veranderingen in de functionele pulmonale beeldvorming parameters te meten in functie van de op korte termijn iNO administratie met behulp van het medisch INOpulse® device bij patiënten met WHO groep 3 PH geassocieerd met COPD (Deel 2) en bij patiënten met WHO groep 3 PH geassocieerd met IPF (Deel 2) die LTOT krijgen. In deel 1 werd iNO toegediend door het te onderzoeken INOpulse® DS-C device. In deel 2 zal het INOpulse® device worden gebruikt.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1
    1. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
    2. Pulmonary hypertension determined by 1 of the following within the past 12 months
    a. A right heart catherization (not obtained within ± 7 days of an exacerbation) with an mPAP ≥ 25 mmHg, or
    b. An echocardiogram (not obtained within ± 7 days of an exacerbation) with a TRV ≥ 2.9 meters per second (m/s), or a systolic PAP ≥ 38 mmHg by 2-D echocardiogram.
    (Note: a subject with a TRV < 2.9 m/s will meet this inclusion criteria if there is an acceptable mPAP ≥ 25 mmHg determined by right heart catherization)
    3. Current or former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry
    4. Age ≥ 40 years, ≤ 80 years
    5. A post-bronchodilatory FEV1/FVC < 0.7 and a FEV1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ± 7 days of an exacerbation; otherwise, the test must be performed during screening)
    6. Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history
    7. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
    8. Signed informed consent prior to the initiation of any study mandated procedures or assessments
    Part 2:
    1. Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on;
    • HCRT: usual interstitial pneumonia
    • FVC: 50-90% of predicted FVC
    2. PH defined as sPAP ≥ 50 mm Hg by echocardiogram
    3. Age ≥ 40 years
    4. Receiving LTOT for ≥ 3 months
    5. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
    6. Signed informed consent prior to the initiation of any study mandated procedures or assessments
    Deel 1:
    1. Een bevestigde diagnose van COPD door de Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
    2. Pulmonale hypertensie bepaald in de afgelopen 12 maanden door 1 van de volgende :
    a. Een rechter hart catheterisatie (niet binnen ± 7 dagen van een exacerbatie) met een mPAP ≥ 25 mmHg of
    b. Een echocardiogram (niet binnen ± 7 dagen van een exacerbatie) met een TRV ≥ 2,9 meter per seconde (m /s), of een systolische PAP ≥ 38 mmHg door een 2-D echocardiogram.
    (Opmerking: een patiënt met een TRV <2,9 m / s zal voldoen aan deze criteria als er een aanvaardbaar mPAP ≥ 25 mmHg bepaald wordt door een rechter hart catheterisatie)
    3. Huidige of ex-rokers met minstens 10 pack-jaren rookgeschiedenis vóór de studie
    4. Leeftijd ≥ 40 jaar, ≤ 80 jaar
    5. Een post-bronchusdilatoire FEV1 / FVC <0,7 en een FEV1 <60% predicted (waarden verkregen binnen de 6 maanden vóór de screening kunnen worden gebruikt, tenzij verkregen binnen ± 7 dagen van een exacerbatie, anders moet de test bij screening worden uitgevoerd)
    6. Het ontvangen van LTOT gedurende ≥ 3 maanden en ≥ 10 uur per dag, zoals bepaald door de geschiedenis
    7. Vruchtbare vrouwen moeten een negatieve urine zwangerschapstest hebben vóór de behandeling
    8. Ondertekend geïnformeerde toestemming voorafgaand aan alle procedures of beoordelingen in opdracht van de studie
    Deel 2:
    1. Een bevestigde diagnose van IPF door een verantwoordelijke en ervaren longarts en op basis van;
    • HCRT: gebruikelijke interstitiële pneumonie
    • FVC: 50-90% van de voorspelde FVC
    2. PH bepaald als SPAP ≥ 50 mm Hg door een echocardiogram
    3. Leeftijd ≥ 40 jaar
    4. Het ontvangen van LTOT gedurende ≥ 3 maanden
    5. Vruchtbare vrouwen moeten een negatieve urine zwangerschapstest hebben vóór de behandeling
    6. Ondertekend geïnformeerde toestemming voorafgaand aan alle procedures of beoordelingen in opdracht van de studie

    E.4Principal exclusion criteria
    Part 1:
    1. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
    2. Lack of patency of nares upon physical examination
    3. Experienced during the last month an exacerbation requiring:
    a) start of or increase in systemic oral corticosteroid therapy, and/or
    b) hospitalization
    4. Left ventricular dysfunction as measured by:
    Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or
    Screening echocardiographic evidence of left ventricular diastolic dysfunction greater than moderate (i.e., > Grade 2), or
    Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mm Hg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
    5. Renal impairment (i.e., an estimated GFRMDRD < 30 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007):
    estimated GFRMDRD = 175×Scr-1.154×Age-0.203 ×1.212 (if black) ×0.742 (if female)
    where Scr = Standardized serum creatinine
    Subjects with possible compromised kidney function (eGFRMDRD between 30 and 60 ml/min/1.73 m2) may be enrolled provided the Radiology Department and Principal Investigator review the medical records of subjects with an eGFRMDRD between 30 and 60 ml/min/1.73 m2 in order to confirm the contrast agent can be safely administered to these subjects and approval by both the Radiology Department and Principal Investigator must be obtained before enrolling these subjects.
    6. Known allergy to contrast media.
    7. Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
    8. Use within 30 days of screening or current use of approved PH medications such as sildenafil or bosentan (use of Cialis® or Viagra® for erectile dysfunction is permitted)
    9. Use of investigational drugs or devices within 30 days prior to enrollment into the study
    10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
    Part 2:
    1. Patients with a current IPF exacerbation or exacerbation within the past 30 days.
    2. Lack of patency of nares upon physical examination
    3. Left ventricular dysfunction as measured by:
    a) Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or
    b) Screening echocardiographic evidence of left ventricular diastolic dysfunction > moderate (i.e., > Grade 3), or
    c) Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mmHg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
    4. Renal impairment (i.e., an estimated GFRMDRD < 30 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007): estimated GFRMDRD = 175 × Scr -1.154 × Age-0.203 × 1.212 (if black) × 0.742 (if female) where Scr = Standardized serum creatinine
    Subjects with possible compromised kidney function (eGFRMDRD between 30 and 60 ml/min/1.73 m2) may be enrolled provided the Radiology Department and Principal Investigator review the medical records of subjects with an eGFRMDRD between 30 and 60 ml/min/1.73 m2 in order to confirm the contrast agent can be safely administered to these subjects and approval by both the Radiology Department and Principal Investigator must be obtained before enrolling these subjects.
    5. Known allergy to contrast media.
    6. Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
    7. Use within 30 days of screening or current use of approved specific PH medications (ERA or PDE-5 inhibitor, or oral, inhaled, subcutaneous, or intravenous prostacyclin or a prostacyclin analog)
    8. Use of investigational drugs or devices within 30 days prior to enrollment into the study
    9. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this exploratory study is the change from baseline in lobar blood volume at total lung capacity (TLC) after dosing with pulsed iNO (Part 1) and iNO or Placebo (Part 2a) as measured by HRCT.
    Het primaire eindpunt in deze verkennende studie is de verandering ten opzichte van baseline in lobaire bloedvolume op de totale longcapaciteit (TLC) na toediening van gepulste iNO (Deel 1) en iNO of Placebo (Deel 2) gemeten door HRCT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Treatment Visit: at Baseline and after administration of iNO
    Part 2a: Treatment Visit A: at Baseline and after administration of iNO/Placebo and Treatment Visit B (at least 5 Days after Treatment Visit A): at Baseline and after administration of iNO/Placebo
    E.5.2Secondary end point(s)
    Secondary endpoints in this exploratory study are the changes from baseline measured by HRCT after dosing with pulsed iNO (Part 1) and iNO or Placebo (Part 2a) in:
    • Blood vessel % and density on lobar level
    • Total lung volume at TLC
    • Lobar volumes at TLC
    • Internal airflow distribution based on lobar expansion
    • Airway volume down to generation 8-10 at TLC
    • Computational Fluid Dynamics (CFD)-based resistance on lobar level
    • Ventilation/perfusion (V/Q) matching
    Part 2a only (Acute; Placebo vs. iNO 75 mcg/kg IBW/hr)
    • Change in Borg Dyspnea Score (LTOT, iNO/Placebo + LTOT, LTOT post iNO/Placebo exposure, and 24 hrs post iNO/Placebo exposure)
    • Changes in breathing questionnaire (LTOT, LTOT post iNO/Placebo exposure, and 24 hrs post iNO/Placebo exposure)
    • Changes in RV and LV function (LTOT, iNO/Placebo + LTOT, post iNO/Placebo LTOT alone) by echocardiogram
    Part 2b Only (Chronic dosing)
    • Change in 6MWT with Borg Dyspnea Score and SpO2, at the beginning and end of the 6MWT and symptoms evaluated using a questionnaire after 4 weeks use of iNO 75 mcg/kg IBW/hr and 2 weeks post discontinuation of iNO
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1: Treatment Visit: at Baseline and after administration of iNO
    Part 2a only:
    - HRCT: Treatment Visit A and B: at Baseline and after administration of iNO/Placebo
    - Borg Dyspnea Score: at Treatment Visit A, B and follow-up: LTOT, iNO/Placebo + LTOT, LTOT post iNO/Placebo exposure, and 24 hrs post iNO/Placebo exposure
    - breathing questionnaire: at Treatment Visit A, B and follow-up: LTOT, LTOT post iNO/Placebo exposure, and 24 hrs post iNO/Placebo exposure
    - echocardiogram: at screening, Treatment Visit A and B
    Part 2b only:
    - Change in 6MWT with Borg Dyspnea Score and SpO2, at the beginning and end of 6MWT: Visit 1, 2, 3, and 4
    - Borg Dyspnea Score: Visit 1, 2, 3, and 4
    - breathing questionnaire: Visit 1, 2, 3, and 4
    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 Yes
    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) Yes
    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
    Exploratory human pharmacol. study with the intent of determining the utility of proposed biomarker
    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 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 Yes
    E.8.1.7.1Other trial design description
    An Exploratory, Two-Part, Clinical Study. Part 2b is a chronic open label design.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 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 years1
    E.8.9.1In the Member State concerned months10
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    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)
    Part 1: Normal treatment of COPD patients
    Part 2: Normal treatment of IPF patients
    Deel 1: Normale behandeling van COPD patiënten.
    Deel 2: Normale behandeling van IPF patiënten
    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 Decision2014-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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