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

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

Drug Information available for:

Fluticasone Fluticasone propionate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

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

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:	September 2009
Estimated Primary Completion Date:	April 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

Responsible Party:	University ofChicago ( Robert Naclerio, MD )
Study ID Numbers:	15059B
First Received:	December 21, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00584987
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine

Otorhinolaryngologic Diseases

Salicylsalicylic acid

Sodium Salicylate

Rhinitis

Naphazoline

Oxymetazoline

Respiratory Tract Diseases

Respiratory Tract Infections

Phenylephrine

Guaifenesin

Fluticasone

Ephedrine

Phenylpropanolamine

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

Adrenergic Agonists

Nasal Decongestants

Therapeutic Uses

Vasoconstrictor Agents

Appetite Depressants

Dermatologic Agents

Adrenergic alpha-Agonists

Sympathomimetics

Anti-Asthmatic Agents

Anti-Allergic Agents

Cardiovascular Agents

Protective Agents

Pharmacologic Actions

Nose Diseases

Anti-Obesity Agents

Mydriatics

Autonomic Agents

Expectorants

Peripheral Nervous System Agents

Central Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	University of Chicago GlaxoSmithKline
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00584987