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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: March 26, 2007
Last updated: May 2, 2007
Last verified: May 2007
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.

Condition Intervention Phase
Common Cold
Drug: Xylometazoline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary 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.

Secondary Outcome Measures:
  • To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
  • and duration of relief of nasal obstruction

Estimated Enrollment: 60
Study Start Date: March 2007
Study Completion Date: April 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00452270

United Kingdom
Novartis Investigative Site
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
Principal Investigator: Novartis Investigative Site, Cardiff, Wales, UK
  More Information Identifier: NCT00452270     History of Changes
Other Study ID Numbers: OTCS-CE-301 
Study First Received: March 26, 2007
Last Updated: May 2, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Common cold, xylometazoline

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Cardiovascular Agents
Nasal Decongestants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on May 04, 2016