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    Summary
    EudraCT Number:2013-004355-20
    Sponsor's Protocol Code Number:2013OE005B
    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:2014-03-31
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004355-20
    A.3Full title of the trial
    Randomised, controlled crossover trial to evaluate the Effects of Ambulatory Oxygen on health status in patients with Fibrotic Lung Disease (FLD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ambulatory Oxygen in Fibrotic Lung Disease
    A.3.2Name or abbreviated title of the trial where available
    Ambulatory oxygen and health status in patients with lung fibrosis
    A.4.1Sponsor's protocol code number2013OE005B
    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 SponsorRoyal Brompton and Harefield NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoyal Brompton and Harefield NHS Foundation Trust
    B.5.2Functional name of contact pointIra Jakupovic
    B.5.3 Address:
    B.5.3.1Street AddressResearch Office, Chelsea Wing, Level 2, Sydney Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW3 6NP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02073518109
    B.5.6E-maili.jakupovic@rbht.nhs.uk
    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 Medical Oxygen
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquide 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 nameMedical Oxygen
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxygen Ph. Eur. 100%
    D.3.9.4EV Substance CodeAS1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrotic Lung Diseases (FLDs) are chronic and progressive conditions resulting in substantial morbidity and mortality. The cardinal symptom of all fibrotic Interstitial Lung Diseases (ILDs) is shortness of breath. Although initially present only on strenuous activities, this unfortunately progresses until even routine activities of daily living become severely limited. This has a devastating impact on Quality of Life (QOL).
    E.1.1.1Medical condition in easily understood language
    Fibrotic Lung Disease is defined by the scarring of the lung.
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10022611
    E.1.2Term Interstitial lung disease
    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 main symptom that occurs in fibrotic lung disease (lung scarring) is breathlessness due to the progressive scarring of the lungs, with a profound impact on daily activities. During exercise, lung fibrosis is often associated with a drop in oxygen saturation which can be corrected by the use of supplemental oxygen. In patients with lung scarring, the main cause of overall worsening quality of life is breathlessness.
    The principal research question is the study of the impact of supplemental oxygen on health status.
    We strongly believe that attempts to improve or maintain health status are of crucial importance, especially in this group of respiratory diseases, characterized overall by a poor prognosis and progressive worsening in quality of life.

    E.2.2Secondary objectives of the trial
    The secondary research questions aim to better define the effects of supplemental oxygen on quality of life by evaluating global patient assessment, individual respiratory symptoms, symptoms of depression and anxiety, as well as the effect on monitored and patient-recorded activity parameters.
    In addition, in a subgroup of patients, patients' and carers' experiences regarding the use of ambulatory oxygen and trial participation will be investigated.
    This could be helpful for further studies, with the aim to strengthen the involvement of patients in respiratory research, and the links with researchers in this field.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Fibrotic Lung diseaseDisease (FLD) patients aged 18 – 99 yrs
    2. Desaturation ≤ 88% on a 6MWT on room air
    3. Stable respiratory symptoms in the 4 weeks preceding the trial
    E.4Principal exclusion criteria
    1. Patients meeting criteria for long term oxygen therapy, including hypercapnic patients
    2. Patients expected to change treatment during the course of the study
    3. Significant locomotor or communication difficulties
    4. Patients with sarcoidosis or connective tissue disease affecting the musculoskeletal system
    5. Current smokers
    6. Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The main aim of this project is to establish whether supplemental oxygen in patients with fibrotic ILD whose oxygen saturation falls on exertion during sub-massimal test, leads to a significant improvement in their health status.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.
    E.5.2Secondary end point(s)
    Secondary outcomes will include dyspnoea scores, global patient assessment, monitored and patient-recorded activity parameters, and Quality of Life (QOL) scores assessed by K-BILD questionnaire. We also aim to assess whether the improvement in 6MWT performance induced by portable oxygen can predict benefit of ambulatory oxygen in day to day living.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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
    The end of the trial will coincide with the Last Patient Last Visit (LPLV).
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 0
    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)
    At the end of the trial, all patients will be offered to continue on ambulatory oxygen, as they would have been if they had not taken part in the trial. Like other patients affected from lung fibrosis, they will remain under their regular follow-up clinical visits at the ILD Unit of the Brompton Hospital or of the other two colaborating centres of KIngs' College and Aintree University Hospitals.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-13
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