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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452270

Enrollment

Registered

2007-03-27

Start date

2007-03-31

Completion date

2007-04-30

Last updated

2007-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold

Keywords

Common cold, xylometazoline

Brief summary

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.

Interventions

DRUGXylometazoline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction	—
and duration of relief of nasal obstruction	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026