Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Rhinitis
Intervention: Oxymetazoline Hydrochloride (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of South Florida Official(s) and/or principal investigator(s): RICHARD F LOCKEY, MD, Principal Investigator, Affiliation: USF
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.
Clinical Details
Official title: Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: to evaluate the effectiveness through symptom scores of the addition of oxymetazoline to nasal GCS in subjects with resistant congestion despite .
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and female subjects 18 years of age and older
2. At least a one year history of perennial allergic or non-allergic rhinitis
3. 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.
4. 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.
5. Nasal Congestion Score of 2 or greater at screening visit (Day - 7)
6. 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)
7. Willingness to participate as indicated by signed informed consent
Exclusion Criteria:
1. Presence of hypersensitivity to oxymetazoline or mometasone
2. Women who are pregnant or lactating
3. Women of childbearing potential who are not abstinent or not practicing a medically
acceptable form of contraception
4. Other nasal diseases likely to affect deposition of oxymetazoline such as sinusitis,
nasal polyps, or nasal structural malformations
5. No respiratory tract infections in the last 14 days
6. Infections requiring antibiotics in the last 14 days
7. No oxymetazoline or other nasal sprays in the last 14 days
8. No cardiovascular disease, uncontrolled hypertension or hypertension requiring more
than two drugs to achieve control, or arrythmias
9. Subjects can not be on beta or alpha blockers
10. No diabetes mellitus
11. No presence or history of ocular herpes simplex, cataracts, or glaucoma
12. Subjects who are currently alcohol or drug abusers
13. Inability to cooperate, comply with study procedures or communicate with the
investigator as needed to successfully complete the study
14. No benign prostate hypertrophy
15. A history of psychosis
16. Patients with a planned hospitalization during the study
17. History of drug or alcohol abuse within the past five years
18. An infirmity, disability, or geographical location which seems likely to prevent
regular attendance for patient visits
19. No use of the following medicines or therapies within the time period specified below
prior to Day - 7:
Locations and Contacts
USF, Tampa, Florida 33613, United States
Additional Information
Starting date: January 2005
Last updated: June 27, 2012
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