Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
| Status: | Terminated |
|---|---|
| Conditions: | Allergy, Sinusitis, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 2005 |
| End Date: | March 2010 |
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.
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.
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:
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