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

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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:	October 2010
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

GlaxoSmithKline

Investigators

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Robert Naclerio, MD, University ofChicago
ClinicalTrials.gov Identifier:	NCT00584987 History of Changes
Other Study ID Numbers:	15059B
Study First Received:	December 21, 2007
Last Updated:	June 15, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Oxymetazoline
Phenylephrine
Fluticasone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012