Rhinitis, Allergic, PerennialPhase 2NCT00779545

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

A Phase 2 study testing Mometasone furoate in people with Rhinitis, Allergic, Perennial, run by Organon and Co.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Rhinitis, Allergic, Perennial
What is being tested?: Mometasone furoate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 455 participants
Where: No sites listed yet
Study dates: 8 Apr 2004to 6 Aug 2004
Phase: Phase 2

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

Who may be able to join

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.

Who cannot join

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.

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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.

About this study

Official title: Dose Finding and Dose Regimen Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis

Conditions: Rhinitis, Allergic, Perennial
Being tested: Placebo, Mometasone furoate
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

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

PlaceboDrug
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.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
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.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
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.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
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.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
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.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
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.

Study groups in NCT00779545
Study group	Role	What they receive
Placebo	Placebo comparator	The placebo group was divided into 3 groups receiving 1, 2 or 4 sprays/nostril. The regimen of each placebo group was BID Receives: Drug: Placebo
Mometasone furoate nasal spray 100 mcg QD	Experimental	Not described Receives: Drug: Placebo; Drug: Mometasone furoate
Mometasone furoate nasal spray 200 mcg QD	Experimental	Not described Receives: Drug: Placebo; Drug: Mometasone furoate
Mometasone furoate nasal spray 400 mcg QD	Experimental	Not described Receives: Drug: Placebo; Drug: Mometasone furoate
Mometasone furoate nasal spray 100 mcg BID	Experimental	Not described Receives: Drug: Mometasone furoate
Mometasone furoate nasal spray 200 mcg BID	Experimental	Not described Receives: Drug: Mometasone furoate

What is being measured

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

Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2
Measured: After 2 weeks of treatment

Secondary outcomes (5)

Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)
Measured: After 1 and 2 weeks of treatment
Overall improvement
Measured: After 1 and 2 weeks of treatment
QOL score
Measured: At initial day of treatment and after 2 weeks of treatment
Adverse events
Measured: From initial day of treatment until 7-10 days after treatment is stopped.
Laboratory tests
Measured: From initial day of treatment until treatment is stopped.

Timeline

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

8 Apr 20046 Aug 2004

First posted24 Oct 2008 (estimated)
Study start8 Apr 2004
Primary completion6 Aug 2004
Study completion6 Aug 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rhinitis, Allergic, PerennialStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00779545
Sponsor's protocol ID: P03748
Other IDs: JPC-03-342-20
Status last verified: Feb 2022
First submitted: 23 Oct 2008
Last updated: 15 Aug 2024
Results posted: No
Data monitoring committee: No

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

Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
RecruitingPhase 2
PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Rhinitis Allergic
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis

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