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    Summary
    EudraCT Number:2020-004951-34
    Sponsor's Protocol Code Number:RESP301-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-11-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-004951-34
    A.3Full title of the trial
    Community participants with COPD or bronchiectasis and at risk of Respiratory Viral Infections including SARS-CoV-2: An open-label, multicentre feasibility study of an inhaled nitric oxide generating solution (RESP301)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COmmunity patients at Risk of Viral Infections including SARS-CoV-2 (CORVIS)
    A.3.2Name or abbreviated title of the trial where available
    COmmunity patients at Risk of Viral Infections including SARS-CoV-2
    A.4.1Sponsor's protocol code numberRESP301-005
    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 SponsorThirty Respiratory Limited
    B.1.3.4CountryUnited Kingdom
    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 No
    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 nameRESP301
    D.3.2Product code RESP301
    D.3.4Pharmaceutical form Nebulisation 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 INNSodium nitrite
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15M
    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
    Chronic obstructive pulmonary disease (COPD) and bronchiectasis
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease (COPD) and bronchiectasis
    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 21.1
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    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 primary objective of this study is to assess the feasibility of recruiting and retaining patients with COPD or bronchiectasis who have viral infection symptoms and treating these patients with RESP301 in a community setting.
    E.2.2Secondary objectives of the trial
    The following secondary objectives will be considered in the study population as a whole, and separately in those patients who have confirmed SARS-CoV-2 infection:

    1) To assess the safety and tolerability of RESP301 in patients with COPD or bronchiectasis, who are at high risk of SARS-CoV-2 and other acute respiratory pathogens.
    2) To collect preliminary data on the efficacy of RESP301 in treating exacerbations in patients with COPD or bronchiectasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female of non-childbearing potential or male ≥35 years of age, at the time of signing the informed consent
    2. Able and willing to provide informed consent
    3. Spirometry-confirmed diagnosis of COPD or CT proven bronchiectasis
    E.4Principal exclusion criteria
    1. Unable to safely use a nebuliser as required by the study according to Investigator’s opinion
    2. Severe COPD or bronchiectasis (e.g. requiring hospitalisation), in the opinion of the investigator
    3. History of methaemoglobinaemia
    4. Baseline methaemoglobin concentration (using fingertip sensor) > 2%
    5. Uncontrolled or severe asthma or history of severe bronchospasm
    6. Presence of tracheostomy/inability to provide spirometry or contraindication for performing spirometry
    7. Anticipated transfer to another hospital/GP practice which is not a study site during the treatment period
    8. Allergy to any of the components of the study intervention
    9. Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives whichever is longer
    10. Deemed unlikely to be able to adhere to protocol in view of investigator
    11. Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
    12. Any unstable, uncontrolled or severe medical condition which in the opinion of the investigator would make the patient unsuitable for the trial
    13. Participant lives at home with no other adults in the household
    14. On long-term non-invasive ventilation and/or at higher risk of bronchospasm
    15. Prescribed Nitric Oxide donating agent
    16. Female of childbearing potential
    17. Clinical diagnosis of COPD but Screening Visit spirometry at study centre excludes COPD (i.e. FEV1/FVC ratio is not <0.7)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the feasibility of self-administering RESP301 treatment with nebuliser in terms of:
    - percentage of patients entered into the dormant phase who, having experienced and correctly reported an exacerbation, commence self-administration of the treatment at home
    - compliance with RESP301 administration schedule over the treatment period: for those participants commencing treatment, the percentage of total doses taken
    E.5.1.1Timepoint(s) of evaluation of this end point
    The percentage of patients who commence self-administration of the treatment at home will be evaluated over the study period of 52 weeks.

    Compliance with RESP301 administration schedule will be evaluated based on data collected over the 7-day treatment period.
    E.5.2Secondary end point(s)
    1) Safety and tolerability of RESP301 in terms of:

    - % of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following:
    a) troublesome cough, chest pain or tightness that is deemed unacceptable by the patient
    b) methaemoglobin >5% during or >3% 60 mins post dose
    c) any treatment-related AE that led to participant not being able to complete the test dose, and/or be suitable to be enrolled into the dormant phase in the Investigator’s opinion
    d) >20% reduction in FEV1 or FVC from pre test dose to post test dose and symptoms

    - Total counts and cumulative incidence of:
    a) Adverse Events (AEs)
    b) Serious Adverse Events (SAEs)
    c) Suspected Unexpected Serious Adverse Reactions (SUSARs)
    d) Severe AEs
    e) Treatment-related AEs/SAEs

    2) Efficacy of RESP301 in terms of:
    - % of participants recovered by Day 7 and Day 14 post starting treatment
    - preventing progression of symptoms, based on patient diary, during an exacerbation
    - reducing time to recovery (days until VAS = 0 and/or no exacerbation symptoms recorded)
    - preventing exacerbation-related hospitalisation and/or death
    - change in CCQ score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Percentage of participants able to tolerate the test dose will be evaluated at Screening Visit.

    Data on AEs will be collected at Screening Visit, during the 7-day treatment period and at 28 days following end of treatment (also at 14 days following end of treatment in those participants whose symptoms had not resolved by the end of treatment). AEs reported at these timepoints will be followed up as described in the protocol.

    Efficacy will be evaluated over the 7-day treatment period in all participants who start treatment. Participants whose symptoms had not resolved by the end of the treatment period, will be further evaluated until symptoms resolve to baseline level or until 14 days after the end of treatment, whichever is sooner.
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility of using the treatment in home setting during exacerbation
    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 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.8.6 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 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
    End of the study is defined as the last participant’s last follow up call.
    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 months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    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: 100
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 150
    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)
    Study intervention will not continue beyond this study.
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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