nasal congestion associated with the common cold MedDRA version: 9.1 Level: LLT Classification code 10010106 Term: Common cold
Conditions
Interventions
Trade Name: Otrivine
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: XYLOMETAZOLINE HYDROCHLORIDE
CAS Number: 1218355
Co
Sponsors
Novartis Consumer Health SA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ; Secondary Objective: 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. ; Primary 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. | — |
Countries
United Kingdom
Outcome results
None listed