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    Summary
    EudraCT Number:2006-006690-25
    Sponsor's Protocol Code Number:OTCS-CE-301
    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:2007-01-01
    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 number2006-006690-25
    A.3Full title of the trial
    A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-being of Otrivin F2 in Subjects with a Common Cold
    A.3.2Name or abbreviated title of the trial where available
    A study to evaluate the decongestant effect of Otrivin F2.
    A.4.1Sponsor's protocol code numberOTCS-CE-301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Consumer Health SA
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Otrivine
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Consumer Health UK 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.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNXYLOMETAZOLINE HYDROCHLORIDE
    D.3.9.1CAS number 1218355
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    nasal congestion associated with the common cold
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010106
    E.1.2Term Common cold
    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 is to evaluate the decongestant effect of Otrivin® F2 in subjects with common cold compared to placebo treatment by means of rhinomanometry.

    E.2.2Secondary objectives of the trial
    Secondary objectives are to measure the peak subjective effect, time to onset of subjective relief of nasal obstruction and duration of relief of nasal obstruction by objective measures of nasal obstruction.
    In addition, any effects on sleep, tiredness, general well-being and smell/taste will be studied as exploratory variables with a daily diary.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age or older
    2. provide written informed consent prior to any procedures being conducted.
    3. report a minimum score of 2 (moderate) nasal congestion associated with a natural cold, according to a 4 point scale (0= not present, 1 = mild, 2 = moderate, 3 = severe).
    4. report cold symptoms of a duration less than 36 hours prior to entry to the study.
    5. report a minimum of 2 common cold symptoms as present on entry to the study (runny nose, blocked nose, sore throat, cough).
    6. Be a male or non pregnant, non lactating female. Women of childbearing potential defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implant-table, patch, oral), and double barrier methods (any double combination of L IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may include total abstinence at the discretion of the Investigator in case where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study.
    7. be willing and able to comply with the requirements of the study; most particularly willing to undergo measurement of total nasal airway resistance using active posterior rhinomanometry and able to record sign/symptom scores.
    E.4Principal exclusion criteria
    1. inability to abstain from smoking for 1 hour before and the duration of each visit.
    2. NAR of < 0.2 Pa/cm3/sec at screening visit 1.
    3. a history of perennial allergic rhinitis (defined as congested/runny nose for more than 2 continuous weeks in the previous 12 months). (Subjects with a history of seasonal allergic rhinitis will not be excluded from participation in the study if recruited out of season.
    4. a clinically significant abnormality as determined by the investigator.
    5. participation in a trial of an investigational drug or device within 30 days.
    6. obstructive nasal polyps or significant nasal tract structural malformations including a deviated septum or a concha bullosa as documented by physical exam.
    7. a history of trans-sphenoidal hypophysectomy.
    8. a history of rhinitis medicamentosa.
    9. a bacterial sinusitis infection during the past 2 weeks prior to study entry;
    10. use of antibiotics or alpha adrenergic drugs (all forms) within the past 1 week, use of glucocorticosteroids (all forms) within the past month.
    11. use of any medication that may affect sleep as judged by the investigator
    12. a known hypersensitivity to or idiosyncratic reaction to xylometazoline or any of the excipients.
    13. regular intake of more than 6 units (as defined in UK medical practice) of alcohol daily.
    14. use of antidepressant drugs or monoamine oxidase inhibitors
    15. employment of the subject or their immediate family members at the clinical research centre.
    16. a diagnosis of arterial hypertension which is not well controlled.
    17. previous participation in this trial.
    18. considered unsuitable for entry into the study by the Clinical Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the upper airway conductance at 1 hour. Analyses of the primary efficacy parameter will be conducted for the ITT and PPS. The analysis of the ITT will be considered the primary efficacy analysis.

    Nasal airway resistance (NAR) values will be converted to nasal conductance by using the formula NAR = deltaP/V. The conductance values have a more normal distribution than resistance. Resistance tends towards a value of infinity in severely obstructed noses whereas conductance moves towards a value of zero. The use of conductance instead of resistance allows data from severely or completely obstructed patients to be used in the statistical analysis.
    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 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) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    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.8.3 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 Information not present in EudraCT
    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
    end of study is defined as last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    The treatment will be discontinued after a maximum of 10 days or after cessation of the symptoms, whichever is sooner. No further treatment is planned for subjects participating in this trial.
    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 Decision2007-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-30
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