Seasonal Allergic RhinitisPhase 2NCT00552110

Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

A Phase 2 study testing OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY), mometasone furoate nasal spray (MFNS) once daily and oxymetazoline nasal spray (OXY) twice daily in people with Seasonal Allergic Rhinitis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Seasonal Allergic Rhinitis
What is being tested?: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY), mometasone furoate nasal spray (MFNS) once daily and oxymetazoline nasal spray (OXY) twice daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 707 participants
Where: No sites listed yet
Study dates: Jul 2007to Feb 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Must be 12 years of age or older, of either sex, and of any race.
Must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating.
Must have a documented (within the past 12 months) positive skin-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating.
Must be clinically symptomatic at the Screening and Baseline Visits.
Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram results.
Must be free of any clinically significant disease, other than SAR, which would interfere with the study evaluations.

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Must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and study requirements.
Female subjects of child-bearing potential must have a negative serum pregnancy test at screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control prior to screening and during the entire study.
Must have the ability to transmit electronic diary data on a regular basis.

Who cannot join

A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
A subject with rhinitis medicamentosa.
A subject with glaucoma and/or increased intraocular pressure.
A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.

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A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
A pregnant or nursing female.
A subject with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, pulmonary, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.

About this study

Official title: Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis

The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Conditions: Seasonal Allergic Rhinitis
Being tested: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY), mometasone furoate nasal spray (MFNS) once daily, oxymetazoline nasal spray (OXY) twice daily, Placebo
Medical subject headings: Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)Drug
Also called MFNS + OXY combination
MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).
OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)Drug
Also called MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1
MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.
mometasone furoate nasal spray (MFNS) once dailyDrug
Also called MFNS QD
MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.
oxymetazoline nasal spray (OXY) twice dailyDrug
Also called OXY BID
OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.
PlaceboDrug
Matching placebo to MFNS given every morning and every evening x 2 weeks.

Study groups in NCT00552110
Study group	Role	What they receive
Combination1	Experimental	Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily Receives: Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
Combination3	Experimental	MFNS with OXY 3 sprays once daily Receives: Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
Mometasone	Active comparator	MFNS once daily Receives: Drug: mometasone furoate nasal spray (MFNS) once daily
Oxymetazoline	Active comparator	OXY twice daily Receives: Drug: oxymetazoline nasal spray (OXY) twice daily
Placebo	Placebo comparator	Placebo nasal spray Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15
Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.
Measured: 15 days of treatment
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score
Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.
Measured: from baseline to hour 4 on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Feb 2008

First posted1 Nov 2007 (estimated)
Study startJul 2007
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 707 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552110
Sponsor's protocol ID: P04500
Status last verified: Feb 2022
First submitted: 30 Oct 2007
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.
PubMed 23562197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Seasonal Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT00552110
Acronym / sponsor ID: P04500
Conditions: Seasonal Allergic Rhinitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 707 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: Jul 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 1 Nov 2007 (estimated)
Results: Posted 8 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 5

Arm	Type	Receives
Combination1	Experimental	Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
Combination3	Experimental	Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)MFNS with OXY 3 sprays once daily
Mometasone	Active comparator	Drug: mometasone furoate nasal spray (MFNS) once dailyMFNS once daily
Oxymetazoline	Active comparator	Drug: oxymetazoline nasal spray (OXY) twice dailyOXY twice daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo nasal spray

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Must be 12 years of age or older, of either sex, and of any race.
Must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating.
Must have a documented (within the past 12 months) positive skin-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating.
Must be clinically symptomatic at the Screening and Baseline Visits.
Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram results.

Key exclusion criteria (9 listed)

A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
A subject with rhinitis medicamentosa.
A subject with glaucoma and/or increased intraocular pressure.

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
OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)Also: MFNS + OXY combinationMFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).	Drug	Combination1
OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)Also: MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.	Drug	Combination3
mometasone furoate nasal spray (MFNS) once dailyAlso: MFNS QDMFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.	Drug	Mometasone
oxymetazoline nasal spray (OXY) twice dailyAlso: OXY BIDOXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.	Drug	Oxymetazoline
PlaceboMatching placebo to MFNS given every morning and every evening x 2 weeks.	Drug	Placebo

Primary outcome

Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15
Time frame: 15 days of treatment
Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score
Time frame: from baseline to hour 4 on Day 1
Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.

Results and safety

Results posted to the registry on 8 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination1	146	142
Combination3	139	134
Mometasone	139	137
Oxymetazoline	141	133
Placebo	142	133

Primary outcome: Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15

Time frame: 15 days of treatment. Least squares mean (Standard Error). Unit: units on a scale

Measure	Combination1 n = 145	Combination3 n = 138	Mometasone n = 139	Oxymetazoline n = 139	Placebo n = 140
Value	-3.29 (0.209)	-3.36 (0.216)	-2.97 (0.213)	-2.44 (0.215)	-1.90 (0.209)

Combination1 vs Oxymetazoline: p = 0.002, ANCOVA
Combination3 vs Oxymetazoline: p <0.001, ANCOVA
Mometasone vs Placebo: p <0.001, ANCOVA

Population analysed: Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug

Primary outcome: Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score

Time frame: from baseline to hour 4 on Day 1. Least squares mean (Standard Error). Unit: units on a scale

Measure	Combination1 n = 144	Combination3 n = 138	Mometasone n = 139	Oxymetazoline n = 139	Placebo n = 140
Value	-0.80 (0.056)	-0.92 (0.057)	-0.63 (0.057)	-1.06 (0.057)	-0.57 (0.056)

Combination1 vs Mometasone: p = 0.021, ANCOVA
Combination3 vs Mometasone: p <0.001, ANCOVA
Oxymetazoline vs Placebo: p <0.001, ANCOVA

Population analysed: Intention to treat: all randomized subjects who had taken at least one dose of study drug

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination1	0 of 145 (0%)	7 of 145 (4.8%)	Not reported
Combination3	0 of 139 (0%)	5 of 139 (3.6%)	Not reported
Mometasone	1 of 139 (0.7%)	10 of 139 (7.2%)	Not reported
Oxymetazoline	0 of 140 (0%)	7 of 140 (5%)	Not reported
Placebo	1 of 142 (0.7%)	8 of 142 (5.6%)	Not reported

Limitations and caveats (from the sponsor): Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23562197Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.
Individual participant dataSharing planned: No

Related trials for Seasonal Allergic Rhinitis

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
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Active, not recruitingPhase 3
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Enrolling by invitationObservational study
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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.

Ariel A Teper, MD study director

Schering-Plough

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 9 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 (time frame: 15 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00552110, which also lists 1 linked publication.

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 14 May 2024.