Intranasal Steroids and Oxymetazoline in Allergic Rhinitis

NCT00584987 | Completed Phase 4 Results DMC

• 1 other identifier: 15059B
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Total Nasal Congestion Symptom Score

  The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).

  28 days of treatment

Secondary Outcomes (5)

• RQLQ Score [Baseline]

  assessed at baseline

• RQLQ Score [2 Weeks]

  assessed 2 weeks after initiation of treatment regimen

• RQLQ Score [4 Weeks]

  assessed 4 weeks after initiation of treatment regimen

• RQLQ Score [6 Weeks]

  assessed 6 weeks after initiation of treatment regimen

• Total NPIF

  days 2 through 28 of the treatment cycle

Study Arms (4)

Placebo FF + Placebo OXY

PLACEBO COMPARATOR

Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm

Drug: Placebo Fluticasone furoate; Drug: Placebo Oxymetazoline

FF + Placebo OXY

ACTIVE COMPARATOR

Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm

Drug: Fluticasone furoate; Drug: Placebo Oxymetazoline

Placebo FF + OXY

ACTIVE COMPARATOR

Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm

Drug: Placebo Fluticasone furoate; Drug: Oxymetazoline

FF + OXY

ACTIVE COMPARATOR

Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm

Drug: Fluticasone furoate; Drug: Oxymetazoline

Interventions

Fluticasone furoate DRUG

2 puffs of each nasal spray in each nostril in the pm

Also known as: Veramyst

FF + OXY; FF + Placebo OXY

Placebo Fluticasone furoate DRUG

2 puffs of each nasal spray in each nostril in the pm

Placebo FF + OXY; Placebo FF + Placebo OXY

Oxymetazoline DRUG

2 puffs of each nasal spray in each nostril in the pm

Also known as: Oxymetazoline hydrochloride

FF + OXY; Placebo FF + OXY

Placebo Oxymetazoline DRUG

2 puffs of each nasal spray in each nostril in the pm

FF + Placebo OXY; Placebo FF + Placebo OXY

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 morning and evening score of ≥4 for nasal congestion in the day preceding entry

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Baroody FM, Brown D, Gavanescu L, DeTineo M, Naclerio RM. Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2011 Apr;127(4):927-34. doi: 10.1016/j.jaci.2011.01.037. Epub 2011 Mar 5.

  PMID: 21377716 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

fluticasone furoate; Fluticasone; Oxymetazoline

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Robert M. Naclerio, MD
• Organization: The University of Chicago

rnacleri@surgery.bsd.uchicago.edu

(773) 702-1865

Study Officials

• Robert M Naclerio, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 17, 2013
• Results First Posted: December 17, 2013

Record last verified: 2013-10

Locations

US (1)