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    Summary
    EudraCT Number:2018-000065-37
    Sponsor's Protocol Code Number:DOSA_Protocol
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-12-07
    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 number2018-000065-37
    A.3Full title of the trial
    Randomised controlled trial of nasal decongestants versus placebo to prolong treatment free periods from continuous positive airway pressure therapy in mild to moderate obstructive sleep apnoea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Decongestants in Obstructive Sleep Apnoea
    A.3.2Name or abbreviated title of the trial where available
    Decongestants in Obstructive Sleep Apnoea (DOSA)
    A.4.1Sponsor's protocol code numberDOSA_Protocol
    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 SponsorUniversity of Oxford
    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 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 Yes
    D.2.1.1.1Trade name Sudafed Congestion Relief 10ml
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Products Limited
    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 nameSudafed Congestion Relief 10ml
    D.3.2Product code PL 15513/0368
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    Oromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNxylometazoline
    D.3.9.1CAS number 526-36-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obstructive Sleep Apnoea Syndrome
    E.1.1.1Medical condition in easily understood language
    Collapse of the upper parts of the airway and throat during sleep leading to poor quality and disrupted sleep
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029983
    E.1.2Term Obstructive sleep apnoea syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028735
    E.1.2Term Nasal congestion
    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 compare the effect of Xylometazoline versus placebo on the time to return of Obstructive Sleep Apnoea (OSA) in patients with mild to moderate OSA following withdrawal of CPAP therapy
    E.2.2Secondary objectives of the trial
    To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy.

    To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is willing and able to give informed consent for participation in the trial.
    2. Male or Female, aged 18 years or above.
    3. Diagnosed with proven obstructive sleep apnoea, with an ODI > 15 and < 30 on original diagnostic sleep study.
    4. Established on CPAP treatment for > 3 months with mean usage of > 4 hours/ night for last 3 months
    5. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
    6. Willing to withdraw from CPAP treatment for 28 days
    7. Good mobile phone reception
    8. Use of Wi-Fi at home
    E.4Principal exclusion criteria
    1. Significant renal or hepatic impairment.
    2. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
    3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
    4. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
    5. Professional driver or, as assessed by the local investigator, any other vigilance critical activity.
    6. Daytime SaO2 <93%, or any prior arterial blood gas performed on air showing PaO2 <8.0 kPa or PaCO2 > 6.0,
    significant hypoventilation on diagnostic sleep study mean saturation <92%
    7. Previous or current history of central sleep apnoea or Cheyne-Stokes respiration.
    8. Previous history of a sleepiness-related accident.
    9. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
    10. Participants with a fructose intolerance
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the number of days to return of obstructive sleep apnoea on overnight pulse oximetry (oxygen desaturation index >15 on 3 consecutive nights) or until patient is unwilling to continue without CPAP and restarts their device.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum treatment duration 28 days, or sooner if overnight oximetry shows return of obstructive sleep apnoea (oxygen desaturation index >15 on 3 consecutive nights).
    E.5.2Secondary end point(s)
    1. To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy

    2. To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Patient reported sleepiness on Epworth Sleepiness Score at baseline, and weekly (day 0, 7, 14, 21 and 28) until 35 days

    2. Overnight pulse oximetry during withdrawal of CPAP, (maximum 28 days) to assess pulse rate variability
    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.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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    The end of trial is the date the last participant’s seven day e-diary card has been returned.
    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 months7
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 state232
    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)
    Once the participants trial period has finished (28 days of treatment) the participant will return to their usual care of CPAP treatment and no further intervention will be provided.
    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 Decision2019-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-30
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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