Perennial Allergic RhinitisPhase 3NCT00783224

A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

A Phase 3 study testing Mometasone and Fluticasone in people with Perennial 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.

Trial summary

This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Perennial Allergic Rhinitis
What is being tested?: Mometasone and Fluticasone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 351 participants
Where: No sites listed yet
Study dates: Sep 2005to Dec 2005
Phase: Phase 3

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 with perennial allergic rhinitis meeting all of the followings.
Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the "Guidelines for the Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period
Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test
Outpatients aged 16 years or over at informed consent
Patients in either sex
Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent
Patients capable of recording nasal allergy diary every day

Who cannot join

Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization
Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available
Patients with a complication of recurrent epistaxis
Patients with uncured nasal septal ulcer, operated nose or nasal trauma.
Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs
Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study

Show all 17Show fewer

Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition
Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens
Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis
Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs
Patients with a complication of a disease (acute upper respiratory tract inflammation, acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms within 7 days before enrollment
Patients who have previously received MF nasal spray
Patients who used FP nasal spray within 28 days before initiation of the pre-treatment observation period (7 days before enrollment to randomization)
Patients who have participated in clinical trials of other investigational product(s) within 120 days (4 months) before obtaining informed consent or participating at present
Patients in whom prior medication expected to be effective for allergic rhinitis was not drawn 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 90 days (3 months) before obtaining informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 180 days (6 months) before obtaining the informed consent)
Other patients whom the investigator or the subinvestigator judged to be inappropriate for participation in the present study

About this study

Official title: Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis

Conditions: Perennial Allergic Rhinitis
Being tested: Placebo for MF, Placebo for FP, Mometasone, Fluticasone
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.

Placebo for MFDrug
Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Placebo for FPDrug
Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
MometasoneDrug
Also called SCH 032088, Nasonex
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
FluticasoneDrug
Also called Flonase
Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

Study groups in NCT00783224
Study group	Role	What they receive
Mometasone Furoate Placebo (PLAMF)	Placebo comparator	Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray Receives: Drug: Placebo for MF
Fluticasone Propionate Placebo (PLAFP)	Placebo comparator	Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray Receives: Drug: Placebo for FP
Mometasone Furoate (MF)	Experimental	Mometasone furoate nasal spray 200 μg/day(QD) Receives: Drug: Mometasone
Fluticasone Propionate (FP)	Active comparator	Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) Receives: Drug: Fluticasone

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) After 2 Weeks
The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.
Measured: Baseline to 2 weeks of treatment

Timeline

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

Sep 2005Dec 2005

First posted31 Oct 2008 (estimated)
Study startSep 2005
Primary completionNov 2005
Study completionDec 2005

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 Perennial 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00783224
Sponsor's protocol ID: P04512
Status last verified: Feb 2022
First submitted: 30 Oct 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

N. Sou et. al; Allergology & Immunology 16(3) page 394-413, (2009.02) -Japanese language journal

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

All Perennial Allergic Rhinitis trials