Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold


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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double


  • Drug: Xylometazoline

Clinical Trial Outcome Measures

Primary 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.

Secondary Measures

  • 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

Inclusion Criteria

  • Over 18 years
  • Have had moderate common cold symptoms for less than 36 hours.

Exclusion Criteria

  • 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

Investigator Details

  • Lead Sponsor
    • Novartis
  • Overall Official(s)
    • Novartis Investigative Site, Cardiff, Wales, UK, Principal Investigator,

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.