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Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)

This study has been completed.
Information provided by:
Nycomed Identifier:
First received: May 24, 2007
Last updated: May 4, 2012
Last verified: February 2008
The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.

Condition Intervention
Common Cold
Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional, Non-controlled, Post-marketing Study to Obtain Knowledge of the Safety of ZyComb® (Xylometazoline Hydrochloride 0.5 mg/mL and Ipratropium Bromide 0.6 mg/mL) for Symptoms of Common Cold in a Real-life OTC Setting

Resource links provided by NLM:

Further study details as provided by Nycomed:

Estimated Enrollment: 1000
Study Start Date: December 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)
    Common cold in a real-life OTC setting

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day. Male or female patients over 18 years of age, visiting any of the participating pharmacies are eligible for inclusion.

Inclusion Criteria:

  • For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00480194

Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

Responsible Party: Nycomed Identifier: NCT00480194     History of Changes
Other Study ID Numbers: XY-005-IM
Study First Received: May 24, 2007
Last Updated: May 4, 2012

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Vasoconstrictor Agents processed this record on May 25, 2017