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CompletedNCT00779545Updated Aug 15, 2024

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

A Phase 2 interventional study of Placebo and Mometasone furoate in Rhinitis, Allergic, Perennial, sponsored by Organon and Co. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Apr 2004, registered Oct 2008).
Phase
Phase 2
Study type
Interventional
Enrollment
455
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.

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 455 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
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients of mongoloid race residing in Japan who satisfy all of the following criteria:

    • Patients having symptoms of allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining the informed consent during the pretreatment observation period.
    • Patients in whom the skin or specific IgE test is positive and the cytological examination for eosinophils in nasal discharge or nasal challenge test is positive.
    • Out-patients aged 16 years or over at the time of obtaining the informed consent.
    • Male or female.
    • Patients from whom the informed consent can be obtained in writing (or the informed consent can be obtained from the patient's legally acceptable representative, if under 20 years).
    • Patients who can daily complete the nasal allergy diary.

Exclusion criteria

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria are not included in the present study:

    • Patients with a complication of tuberculous disease or lower respiratory tract infection, or patients with a complication of acute upper respiratory tract inflammation or acute laryngopharyngitis which the (sub) investigator considers necessary to treat at the time of enrollment in the treatment.
    • Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available.
    • Patients with unhealed nasal septum ulcer, nasal surgery, or nasal trauma.
    • Patients with hypersensitivity to steroids and mometasone furoate.
    • Patients who are pregnant, nursing, or possibly pregnant, or who desire to become pregnant during the study period.
    • Patients with severe hepatic, renal, or cardiac disorder, blood disease, diabetes, hypertension, or other serious complication, suffering from problems with systemic condition.
    • Patients in whom pollen is an overlapping allergen and the study is planned to be implemented in the pollen release season.
    • Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis.
    • Patients with a complication of nose disease which may interfere with efficacy evaluation of the investigational product.
    • Patients who were complicated by acute upper respiratory tract inflammation during the 7-day observation period prior to enrollment which may affect the nasal symptoms.
    • Patients who have previously received mometasone furoate nasal spray.
    • Patients who have participated in clinical trial of other investigational product(s) within 4 months before obtaining the informed consent or are participating at present.
    • Patients in whom prior medication effective against allergic rhinitis was withdrawn not long enough before initiation of treatment with the investigational product or the preceding medication cannot be withdrawn.
    • Patients who are being treated with specific desensitization therapy or nonspecific allassotherapy or in whom such the therapy was withdrawn within 3 months before obtaining the informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 6 months before obtaining the informed consent).
    • Other patients whom the (sub) investigator judged to be inappropriate for participation in the present study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
455 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    The placebo group was divided into 3 groups receiving 1, 2 or 4 sprays/nostril. The regimen of each placebo group was BID

    Drug: Placebo

  • Experimental
    Mometasone furoate nasal spray 100 mcg QD

    Drug: Placebo · Drug: Mometasone furoate

  • Experimental
    Mometasone furoate nasal spray 200 mcg QD

    Drug: Placebo · Drug: Mometasone furoate

  • Experimental
    Mometasone furoate nasal spray 400 mcg QD

    Drug: Placebo · Drug: Mometasone furoate

  • Experimental
    Mometasone furoate nasal spray 100 mcg BID

    Drug: Mometasone furoate

  • Experimental
    Mometasone furoate nasal spray 200 mcg BID

    Drug: Mometasone furoate

Interventions

  • DrugPlacebo

    One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.

  • DrugMometasone furoate

    One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.

    Also known as: Nasonex, SCH 32088

  • DrugMometasone furoate

    Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.

    Also known as: Nasonex, SCH 32088

  • DrugMometasone furoate

    Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.

    Also known as: Nasonex, SCH 32088

  • DrugMometasone furoate

    One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.

    Also known as: Nasonex, SCH 32088

  • DrugMometasone furoate

    Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.

    Also known as: Nasonex, SCH 32088

06

What researchers measure

Primary outcomes

  1. Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2

    Time frame: After 2 weeks of treatment

Secondary outcomes

  1. Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)

    Time frame: After 1 and 2 weeks of treatment

  2. Overall improvement

    Time frame: After 1 and 2 weeks of treatment

  3. QOL score

    Time frame: At initial day of treatment and after 2 weeks of treatment

  4. Adverse events

    Time frame: From initial day of treatment until 7-10 days after treatment is stopped.

  5. Laboratory tests

    Time frame: From initial day of treatment until treatment is stopped.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00779545
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 24, 2008
Start date
Apr 8, 2004
Primary completion
Aug 6, 2004
Completion
Aug 6, 2004
Last update
Aug 15, 2024

Oversight

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

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