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

Condition(s) targeted: Common Cold

Intervention: Xylometazoline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Investigative Site, Cardiff, Wales, UK, Principal Investigator

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.

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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 outcome:

To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction

and duration of relief of nasal obstruction

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Novartis Investigative Site, Cardiff, Wales, United Kingdom

Starting date: March 2007
Last updated: May 2, 2007