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

This study has been completed.

First Received on May 24, 2007. Last Updated on February 26, 2008 History of Changes

Sponsor:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00480194

Purpose

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:

MedlinePlus related topics: Common Cold

Drug Information available for: Ipratropium bromide Ipratropium Xylometazoline Xylometazoline hydrochloride

U.S. FDA Resources

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:

Common cold in a real-life OTC setting

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480194

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

No publications provided

Responsible Party:	Nycomed
ClinicalTrials.gov Identifier:	NCT00480194 History of Changes
Other Study ID Numbers:	XY-005-IM
Study First Received:	May 24, 2007
Last Updated:	February 26, 2008
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Bromides
Ipratropium
Xylometazoline
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

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
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012