Chronic RhinitisNCT00584662
Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
A study testing Oxymetazoline Hydrochloride in people with Chronic Rhinitis, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- Oxymetazoline Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Patients with a planned hospitalization during the study
- History of drug or alcohol abuse within the past five years
- An infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visits
- No use of the following medicines or therapies within the time period specified below prior to Day -7:
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Oxymetazoline Hydrochloride
- Keywords
- Rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline HydrochlorideDrug
Also called AFRIN
Oxymetazoline Hydrochloride TWO SPRAYS BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oxymetazoline Hydrochloride Receives: Drug: Oxymetazoline Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effectiveness through symptom scores of the addition of oxymetazoline to nasal GCS in subjects with resistant congestion despite .
Measured: 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
Measured: 9 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJan 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lockey, University of South Florida
- Investigators
- RICHARD F LOCKEY, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584662
- Sponsor's protocol ID
- AFRIN STUDY
- Status last verified
- Jul 2008
- First submitted
- 21 Dec 2007
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
- ClinicalTrials.gov ID
- NCT00584662
- Acronym / sponsor ID
- AFRIN STUDY
- Conditions
- Chronic Rhinitis
- Keywords
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Oxymetazoline HydrochlorideOxymetazoline Hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymetazoline HydrochlorideAlso: AFRINOxymetazoline Hydrochloride TWO SPRAYS BID | Drug | 1 |
Primary outcome
to evaluate the effectiveness through symptom scores of the addition of oxymetazoline to nasal GCS in subjects with resistant congestion despite .
Time frame: 9 WEEKS
1 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
Time frame: 9 WEEKS
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RICHARD F LOCKEY, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymetazoline Hydrochloride in people with Chronic Rhinitis, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the effectiveness through symptom scores of the addition of oxymetazoline to nasal GCS in subjects with resistant congestion despite . (time frame: 9 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.