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NCT00584662 · ClinicalTrials.gov registry record · NA
Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
A NA study, sponsored by University of South Florida.
- Terminated
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT00584662 is a NA study that was terminated before completion, run by University of South Florida. The registered enrollment target is 42 participants.
The verdict
NCT00584662, a NA study, was terminated before completion, sponsored by University of South Florida.
- TERMINATED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study 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 am
Interventions
- DRUG Oxymetazoline Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2005-01 |
| Est. Completion | 2010-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00584662
The ClinicalTrials.gov registry entry for NCT00584662 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxymetazoline Hydrochloride is the first listed.
NCT00584662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00584662 about?
NCT00584662 is a clinical study titled "Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion". 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 ...
What is the current status of trial NCT00584662?
This trial is currently terminated. It is a NA study. The enrollment target is 42 participants. The study started on 2005-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00584662?
The interventions under investigation include: Oxymetazoline Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00584662?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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