A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa

This study is currently recruiting participants.

Verified by University of Chicago, May 2009

First Received: December 21, 2007 Last Updated: May 6, 2009 History of Changes

Sponsor:	University of Chicago
Collaborator:	GlaxoSmithKline
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00584987

Purpose

We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: fluticasone furoate and/or oxymetazoline or placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa

Resource links provided by NLM:

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Fluticasone propionate Fluticasone Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

daily change in nasal congestion score [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean changes from baseline in RQLQ [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
mean changes from baseline in NPIF scores [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: fluticasone furoate and/or oxymetazoline or placebo 2 puffs in each nostril once daily in the evening
2: Active Comparator fluticasone furoate	Drug: fluticasone furoate and/or oxymetazoline or placebo 2 puffs in each nostril once daily in the evening
3: Active Comparator oxymetazoline	Drug: fluticasone furoate and/or oxymetazoline or placebo 2 puffs in each nostril once daily in the evening
4: Active Comparator fluticasone furoate and oxymetazoline	Drug: fluticasone furoate and/or oxymetazoline or placebo 2 puffs in each nostril once daily in the evening

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males and females between 18 and 55 years of age.
History of perennial allergic rhinitis.
Positive skin test to dust mite, dog, cat or indoor mold antigen.
And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Subjects treated with systemic steroids during the previous 30 days.
Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
Subjects treated with oral antihistamine/decongestants during the previous seven days.
Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
Subjects treated with immunotherapy and are escalating their dose.
Subjects on chronic anti-asthma medications.
Subjects with polyps in the nose or a significantly displaced septum.
Upper respiratory infection within 14 days of study start.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584987

Contacts

Contact: Marcy deTineo, BSN, CCRC

773-702-5889

mdetineo@surgery.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Robert M Naclerio, MD

Sponsors and Collaborators

University of Chicago

GlaxoSmithKline

Investigators

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

More Information

No publications provided

Responsible Party:	University ofChicago ( Robert Naclerio, MD )
Study ID Numbers:	15059B
Study First Received:	December 21, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00584987 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Physiological Effects of Drugs
Rhinitis
Adrenergic Agonists
Nasal Decongestants
Respiratory Tract Infections
Respiratory Tract Diseases
Phenylephrine
Therapeutic Uses
Vasoconstrictor Agents

Fluticasone
Dermatologic Agents
Adrenergic alpha-Agonists
Otorhinolaryngologic Diseases
Sympathomimetics
Anti-Asthmatic Agents
Anti-Allergic Agents
Cardiovascular Agents
Protective Agents
Nose Diseases
Pharmacologic Actions
Oxymetazoline
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009