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

Overview

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

Interventions

  • 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,

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