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CompletedNCT00468312Updated Feb 9, 2022Results posted

Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)

A Phase 3 interventional study of Mometasone furoate nasal spray and Placebo in Seasonal Allergic Rhinitis, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
429
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.

02

Conditions studied

03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 429 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 study season.
  • Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
  • Must be clinically symptomatic at the Screening Visit.
  • Must be clinically symptomatic at the Baseline Visit.
  • Must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory test (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
  • Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
  • A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.
  • A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.

Exclusion criteria

Exclusion Criteria:

  • A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
  • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • A subject with rhinitis medicamentosa.
  • A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
  • A subject who have had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who have had a viral upper respiratory infection within 7 days before the Screening Visit.
  • A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
  • A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
  • Use of any drug in an investigational protocol in the 30 days before the Screening Visit.
  • A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit.
  • Pregnant or nursing females.
  • Family member of the investigation study staff.
  • Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, 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.
  • Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
  • A subject whose ability to provide informed consent is compromised.
  • A subject with a history of noncompliance with medications or treatment

protocols.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
429 participants (actual)

Study arms

  • Experimental
    Mometasone Furoate Nasal Spray (MFNS)

    200 mcg daily

    Drug: Mometasone furoate nasal spray

  • Placebo comparator
    Placebo

    Two sprays in each nostril in the morning

    Drug: Placebo

Interventions

  • DrugMometasone furoate nasal spray

    Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning

    Also known as: Nasonex

  • DrugPlacebo

    Two sprays in each nostril in the morning

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15

    TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.

    Time frame: Screening through 15 days daily

  2. Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15

    TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.

    Time frame: Screening through 15 days daily

Secondary outcomes

  1. Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15

    Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.

    Time frame: Screening through 15 days daily

  2. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)

    The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.

    Time frame: Baseline and 15 days

  3. Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15

    Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.

    Time frame: Screening through 15 days daily

07

Results

Posted Jun 22, 2010

Participant flow

Participant flow — Overall Study
MilestoneMometasone Furoate Nasal Spray (MFNS)Placebo
Started220209
Completed216204
Not completed45
Withdrew: Adverse event21
Withdrew: Lack of efficacy01
Withdrew: Withdrawal by subject01
Withdrew: Protocol violation21
Withdrew: Did not meet protocol eligibility01

Outcome measures

PrimaryChange From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15

TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.

Time frame:
Screening through 15 days daily
Reported as:
Least squares mean · Score on a scale
Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Score on a scaleMometasone Furoate Nasal Spray (MFNS)Placebo
Baseline TNSS9.31 ± 1.609.31 ± 1.60
Change from Baseline in TNSS-2.54 ± 1.99-1.66 ± 1.99
Statistical analysis
  • Mometasone Furoate Nasal Spray (MFNS) vs Placebo · ANCOVA · p = <0.001Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.
PrimaryChange From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15

TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.

Time frame:
Screening through 15 days daily
Reported as:
Least squares mean · Score on a scale
Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
Score on a scaleMometasone Furoate Nasal Spray (MFNS)Placebo
Baseline TOSS6.78 ± 1.466.74 ± 1.46
Change from Baseline in TOSS-1.71 ± 1.60-1.37 ± 1.60
Statistical analysis
  • Mometasone Furoate Nasal Spray (MFNS) vs Placebo · ANCOVA · p = 0.026Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.
SecondaryChange From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15

Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.

Time frame:
Screening through 15 days daily
Reported as:
Least squares mean · Score on a scale
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Score on a scaleMometasone Furoate Nasal Spray (MFNS)Placebo
Baseline Nasal Congestion Score2.60 ± 0.382.62 ± 0.38
change from Baseline in Nasal Congestion Score-0.59 ± 0.53-0.39 ± 0.53
Statistical analysis
  • Mometasone Furoate Nasal Spray (MFNS) vs Placebo · ANCOVA · p = <0.001Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.
SecondaryChange From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)

The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.

Time frame:
Baseline and 15 days
Reported as:
Least squares mean · Score on a scale
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
Score on a scaleMometasone Furoate Nasal Spray (MFNS)Placebo
Baseline RQLQ Total Score4.27 ± 1.014.28 ± 1.01
Change from Baseline in RQLQ Total Score-1.81 ± 1.36-1.08 ± 1.36
Statistical analysis
  • Mometasone Furoate Nasal Spray (MFNS) vs Placebo · ANCOVA · p = <0.001Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.
SecondaryChange From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15

Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.

Time frame:
Screening through 15 days daily
Reported as:
Least squares mean · liters/minute
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
liters/minuteMometasone Furoate Nasal Spray (MFNS)Placebo
Baseline PNIF93.12 ± 41.391.96 ± 41.3
Change from Baseline in PNIF16.55 ± 36.912.59 ± 36.9
Statistical analysis
  • Mometasone Furoate Nasal Spray (MFNS) vs Placebo · ANCOVA · p = 0.269Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mometasone Furoate Nasal Spray (MFNS)—0/220 (0%)0/220 (0%)
Placebo—0/209 (0%)0/209 (0%)

Baseline characteristics

Age, Customized
Age, Customized(participants)Mometasone Furoate Nasal Spray (MFNS)PlaceboTotal
6 - <12 years011
12 - <18 years312455
18 - <65 years184181365
>=65 years538
Sex: Female, Male
Sex: Female, Male(Participants)Mometasone Furoate Nasal Spray (MFNS)PlaceboTotal
Female132125257
Male8884172
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Prenner BM, Lanier BQ, Bernstein DI, Shekar T, Teper A. Mometasone furoate nasal spray reduces the ocular symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol. 2010 Jun;125(6):1247-1253.e5. doi: 10.1016/j.jaci.2010.03.004. PubMed 20434199 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00468312
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
May 2, 2007
Start date
Mar 2007
Primary completion
Jul 2007
Completion
Jul 2007
Results posted
Jun 22, 2010
Last update
Feb 9, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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