Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion

NCT00584662 | Terminated

• 1 other identifier: AFRIN STUDY
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion. For example, antihistamines are not effective in relieving congestion.1 Oral decongestants are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may also be beneficial in patients with persistent nighttime congestion despite maximum dosages of nasal GCS. Oxymetazoline is currently recommended for three days use because of the proposed risk of rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal decongestant sprays.5-8 The term RM was coined early in the twentieth century after several case reports described patients developing rebound congestion after using first generation intranasal decongestants such as privine hydrochloride and ephedrine for prolonged periods6,7. The histopathology and mechanism of RM has been based on animal models which may not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant, in individuals without rhinitis have shown conflicting evidence for the development of RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times daily for four weeks did not develop RM.17 Also, it is unknown the frequency of administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as privine hydrochloride and ephedrine rather than oxymetazoline. Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema, recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal mediators.19-21 They may offer a protective benefit from the risk of developing RM. Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better adsorption of the nasal GCS. Hypothesis The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of congestion in subjects with allergic or non-allergic rhinitis with persistent congestion despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS protect against the development of RM secondary to oxymetazoline.

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (1)

• to evaluate the effectiveness through symptom scores of the addition of oxymetazoline to nasal GCS in subjects with resistant congestion despite .

  9 WEEKS

Secondary Outcomes (1)

• To evaluate the need for rescue medicine for persistent or worsening congestion.To evaluate evidence of rebound congestion in subjects treated with both nasal GCS and oxymetazoline.To evaluate improvement in the total nasal

  9 WEEKS

Study Arms (1)

1

ACTIVE COMPARATOR

Oxymetazoline Hydrochloride

Drug: Oxymetazoline Hydrochloride

Interventions

Oxymetazoline Hydrochloride DRUG

Oxymetazoline Hydrochloride TWO SPRAYS BID

Also known as: AFRIN

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 years of age and older
• At least a one year history of perennial allergic or non-allergic rhinitis
• Subjects receiving allergen immunotherapy must be on a stable maintenance regimen for at least 30 days before the first study visit and remain on this dosage during the study.
• Subjects must be on the maximum doses of one of the following nasal GCS for at least one month: beclomethasone, flunisolide, fluticasone, mometasone, or triamcinolone.
• Nasal Congestion Score of 2 or greater at screening visit (Day -7)
• Average Nasal Congestion Score of 1.5 or greater at baseline visit (Day 1). Average Nasal Congestion Score is calculated from over the last three days prior to baseline and the morning of the baseline visit (i.e. total of seven scores)
• Willingness to participate as indicated by signed informed consent

You may not qualify if:

• Presence of hypersensitivity to oxymetazoline or mometasone
• Women who are pregnant or lactating
• Women of childbearing potential who are not abstinent or not practicing a medically acceptable form of contraception
• Other nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or nasal structural malformations
• No respiratory tract infections in the last 14 days
• Infections requiring antibiotics in the last 14 days
• No oxymetazoline or other nasal sprays in the last 14 days
• No cardiovascular disease, uncontrolled hypertension or hypertension requiring more than two drugs to achieve control, or arrythmias
• Subjects can not be on beta or alpha blockers
• No diabetes mellitus
• No presence or history of ocular herpes simplex, cataracts, or glaucoma
• Subjects who are currently alcohol or drug abusers
• Inability to cooperate, comply with study procedures or communicate with the investigator as needed to successfully complete the study
• No benign prostate hypertrophy
• A history of psychosis

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• RICHARD F LOCKEY, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: January 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2008-07

Locations

US (1)