Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI
Condition: Upper Respiratory Infections
MeSH terms: Infections; Respiratory Tract Infections
Intervention: IFF flavor 316 282, Paracetamol, Pseudoephedrine
Intervention description: Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Intervention MeSH terms: Acetaminophen; Pseudoephedrine; Ephedrine
Phase: Phase 3
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: paracetamol; pseudoephedrine; syrup; upper respiratory tract infection

Summary:

      This is an open label, in-use study to assess the warming sensation, acceptability and local
      tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in
      subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to
      evaluate the acceptability concerning a warming sensation effect and its potential benefit in
      the target population.

      The primary objective is to assess the warming sensation caused by the excipient IFF flavor
      316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup.
      The syrup contains (0.15% w/v) warming flavor.

      The Secondary Objectives are to assess subject acceptability of the syrup and the safety and
      tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from
      symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal
      congestion associated with colds and flu symptoms such as pain, headache and/or fever.
      Subjects must have one or more symptoms per category:

        1. mild to moderate body pain, headache, fever or sore throat

        2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
           Adolescents will be included in the study population
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have one or more symptoms per category (see also screening assessment of
             cold symptoms, section 6.1):

          -  mild to moderate body pain, headache, fever or sore throat

          -  nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing

        Exclusion Criteria:

          1. Baseline sore throat pain of severe intensity, e.g. rated as 3 on a 4-point ordinal
             scale (0=not present, 1= mild, 2=moderate, 3=severe)

          2. Baseline dry cough of severe intensity, e.g. rated as 3 on a 4-point ordinal scale
             (0=not present, 1= mild, 2=moderate, 3=severe)

          3. Subject has a productive cough.

          4. History of hypersensitivity to any of the study drugs and the listed excipients or to
             drugs of similar chemical classes

          5. Subjects with allergic asthma.

          6. Use of any inhaler, medicated confectionary, throat lozenges, throat pastilles,
             sprays, any products with demulcent properties such as chewing gums and boiled sweets
             or mints, in the 6 hours prior to dosing.

          7. Use of any medication for sore throat containing a local anaesthetic within the 6
             hours prior to dosing.

          8. Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to
             dosing.

          9. Use of substances of abuse or antihistamines within 24 hours of dosing.

         10. Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.

         11. Suffering from hepatic or severe renal impairment, hypertension, hyperthyroidism,
             diabetes, heart disease or other acute or chronic medical condition that, in the
             opinion of the investigator, would put the subject at a higher risk or affect the
             conduct and/or the results of the study.

         12. Use of any antidepressants, monoamine oxidase inhibitors or beta-blocking drugs in the
             28 days prior to dosing

         13. A history of alcohol abuse or subject admits to regular consumption of alcohol in
             excess of the recommended weekly limits of 21 units for females and 28 units for
             males.

         14. Subject is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking
             habits using other tobacco products).

         15. Subject has smoked or chewed tobacco products within 12 hours of dosing.

         16. History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.