Perennial Allergic RhinitisPhase 3NCT00732368
A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis (Study P04459)
A Phase 3 study testing Mometasone furoate in people with Perennial Allergic Rhinitis, run by Organon and Co.
Trial summary
This study examined the safety and effectiveness of long-term administration of mometasone nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12 weeks plus an additional 12 weeks if patient agreed to continue. 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 furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2005to 1 Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Moderate to severe perennial allergic rhinitis, >16 years of age
Who cannot join
- Patients with coexisting tuberculous disease or lower respiratory tract infection and patients who have acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis judged by the investigator to require treatment
- Patients with coexisting infections or systemic mycosis for which there are no effective treatment
- Patients with coexisting mycosis in the nasal and paranasal cavities
- Patients who are judged to require prohibited concomitant drugs during the clinical study
- Patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma, which have not yet healed
- Patients with a history of hypersensitivity to steroids or mometasone furoate
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- Patients who are pregnant or nursing or who may be pregnant and patients or whose partner desires to become pregnant during the study period
- Patients with severe hepatic disorder, renal disorder, cardiac disease, diabetes mellitus, hypertension, or hematological disease or other serious coexisting diseases and whose general condition is poor as judged by the investigators.
- Patients allergic to pollen and the pollen release season occurs in the 7 days before the start of treatment
- Patients diagnosed with vasomotor rhinitis or eosinophilic rhinitis
- Patients with nasal conditions which may interfere with efficacy evaluation of the study drug
- Patients who develop a disease which may affect nasal symptoms in the 7 days before the start of treatment
- Patients who are participating or have participated in a clinical trial of an investigational drug within 120 days before the day of obtaining informed consent
- Patients for whom the period of discontinuation of previous treatment before the start of study drug administration indicated Table 2 is not adequate or who cannot avoid the use of these drugs
- Patients undergoing specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapy within 90 days prior to obtaining informed consent. (However, patients need not be excluded if therapy has been ongoing for at least 180 days before obtaining informed consent and maintenance therapy is now being conducted.)
About this study
Official title: A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis
This study examined the safety and effectiveness of long-term administration of mometasone nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12 weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be decreased or increased during the study based on patient's response.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- 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.
Mometasone furoateDrug
Also called SCH 032088, Nasonex
Two sprays mometasone nasal spray per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily.
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Nasal Spray | Experimental | Open-label. Two sprays per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily. Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 4 nasal symptom score.
Measured: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
Secondary outcomes (4)
Individual nasal symptom scores (sneezing, attack, rhinorrhea, nasal congestion, and nasal itching)
Measured: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
Overall improvement (combination of nasal symptoms and rhinoscopic nasal findings)
Measured: All visits during which patient is receiving drug (includes the 12 week drug administration period plus the 12 week additional drug administration period)
Adverse events
Measured: Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment.
Laboratory tests
Measured: At baseline, and 4, 12, and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study start1 May 2005
- Primary completion1 Jan 2006
- Study completion1 Jan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 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
- NCT00732368
- Sponsor's protocol ID
- P04459
- Status last verified
- Feb 2022
- First submitted
- 8 Aug 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
T. Ishikawa et. al; Practica otologica. Suppl. 122 Page1-17(2008.11) -Japanese language journal
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00732368
- Acronym / sponsor ID
- P04459
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 May 2005 (actual)
- Primary completion
- 1 Jan 2006 (actual)
- Study completion
- 1 Jan 2006 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined the safety and effectiveness of long-term administration of mometasone nasal spray in patients with perennial allergic rhinitis. Patients received mometasone for 12 weeks plus an additional 12 weeks if patient agreed to continue. Dose of mometasone could be decreased or increased during the study based on patient's response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mometasone Nasal Spray | Experimental | Drug: Mometasone furoateOpen-label. Two sprays per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe perennial allergic rhinitis, >16 years of age
Key exclusion criteria (15 listed)
- Patients with coexisting tuberculous disease or lower respiratory tract infection and patients who have acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis judged by the investigator to require treatment
- Patients with coexisting infections or systemic mycosis for which there are no effective treatment
- Patients with coexisting mycosis in the nasal and paranasal cavities
- Patients who are judged to require prohibited concomitant drugs during the clinical study
- Patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma, which have not yet healed
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 |
|---|---|---|
| Mometasone furoateAlso: SCH 032088, NasonexTwo sprays mometasone nasal spray per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily. | Drug | Mometasone Nasal Spray |
Primary outcome
Change from Baseline in 4 nasal symptom score.
Time frame: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
4 secondary outcomes
Individual nasal symptom scores (sneezing, attack, rhinorrhea, nasal congestion, and nasal itching)
Time frame: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration of treatment
Overall improvement (combination of nasal symptoms and rhinoscopic nasal findings)
Time frame: All visits during which patient is receiving drug (includes the 12 week drug administration period plus the 12 week additional drug administration period)
Adverse events
Time frame: Throughout the study once initial treatment has started and until 5 to 9 days after last administration of treatment.
Laboratory tests
Time frame: At baseline, and 4, 12, and 24 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publicationT. Ishikawa et. al; Practica otologica. Suppl. 122 Page1-17(2008.11) -Japanese language journal
Related trials for Perennial Allergic Rhinitis
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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 furoate 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 1 inclusion and 15 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 15 Aug 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline in 4 nasal symptom score. (time frame: All visits starting 2 weeks prior to treatment until 5 to 9 days after last administration 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 NCT00732368, 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 15 Aug 2024.