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.
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
- 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 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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00783224
- Acronym / sponsor ID
- P04512
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 12 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Placebo (PLAMF) | Placebo comparator | Drug: Placebo for MFPlacebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray |
| Fluticasone Propionate Placebo (PLAFP) | Placebo comparator | Drug: Placebo for FPPlacebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray |
| Mometasone Furoate (MF) | Experimental | Drug: MometasoneMometasone furoate nasal spray 200 μg/day(QD) |
| Fluticasone Propionate (FP) | Active comparator | Drug: FluticasoneFluticasone Propionate nasal spray 200 μg/day, twice per day (BID) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Placebo for MFPlacebo 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 | Drug | Mometasone Furoate Placebo (PLAMF) |
| Placebo for FPPlacebo 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 | Drug | Fluticasone Propionate Placebo (PLAFP) |
| MometasoneAlso: SCH 032088, NasonexMometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks | Drug | Mometasone Furoate (MF) |
| FluticasoneAlso: FlonaseFluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks | Drug | Fluticasone Propionate (FP) |
Primary outcome
Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
Time frame: Baseline to 2 weeks of treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationN. Sou et. al; Allergology & Immunology 16(3) page 394-413, (2009.02) -Japanese language journal
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone and Fluticasone in people with Perennial Allergic Rhinitis, run by Organon and Co.
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 7 inclusion and 17 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 9 Feb 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12 Jul 2010). 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 in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks (time frame: Baseline to 2 weeks of treatment). 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 NCT00783224, 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 9 Feb 2022.