The aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.
Full Title of Study: “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 Xylometazoline in Subjects With a Common Cold”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Drug: Xylometazoline
Clinical Trial Outcome Measures
- To evaluate the decongestant effect of xylometazoline in subjects with
- common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
- To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
- and duration of relief of nasal obstruction
Participating in This Clinical Trial
- Over 18 years
- Have had moderate common cold symptoms for less than 36 hours.
- Congested/runny nose for more than two continuous weeks in the previous 12 months
- Deviated septum or nasal polyps
- Recent use of antibiotics
- Recent sinusitis
Other protocol-defined inclusion/exclusion criteria may apply.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Overall Official(s)
- Novartis Investigative Site, Cardiff, Wales, UK, Principal Investigator,
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