Rhinitis, AllergicPhase 4NCT00834119
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
A Phase 4 study testing Mometasone furoate in people with Rhinitis, Allergic, run by Organon and Co.
Trial summary
This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Mometasone furoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2003to 1 Apr 2004
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
- Subjects must be between 18-65 years of age, of either sex and any race
- Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
- Subjects must be mometasone furoate naïve.
Who cannot join
- Significant comorbid medical condition.
- Respiratory tract infection.
- Any contraindications according to mometasone furoate product monograph.
- Patients who have received antihistamine treatment within the last 5 days.
- Patients who have received corticosteroid treatment within the last 30 days.
- Patients who are likely to require the administration of systemic steroids during the course of this program.
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- Any condition which in the doctor's opinion could interfere with the patient completion of this program.
- Pregnant or lactating patients.
- Patients with local infections involving the nasal mucosa.
- Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
- Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
- Patients who are prone to nose bleeding.
About this study
Official title: Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine
This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.
- Conditions
- Rhinitis, Allergic
- Being tested
- Mometasone furoate
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoateDrug
Also called Nasonex, SCH 32088
Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
Mometasone furoateDrug
Also called Nasonex, SCH 32088
Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate | Experimental | Not described Receives: Drug: Mometasone furoate |
| Mometasone furoate plus an oral antihistamine | Experimental | Not described Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
Measured: Day 28 and Day 56
Secondary outcomes (2)
Patient satisfaction with intranasal steroid monotherapy.
Measured: Day 28
Potential benefit of an oral antihistamine in combination with an intranasal steroid
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study start1 Sep 2003
- Primary completion1 Apr 2004
- Study completion1 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT00834119
- Sponsor's protocol ID
- P03270
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
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
- Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine
- ClinicalTrials.gov ID
- NCT00834119
- Acronym / sponsor ID
- P03270
- Conditions
- Rhinitis, Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2003 (actual)
- Primary completion
- 1 Apr 2004 (actual)
- Study completion
- 1 Apr 2004 (actual)
- First posted
- 3 Feb 2009 (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 is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate | Experimental | Drug: Mometasone furoate |
| Mometasone furoate plus an oral antihistamine | Experimental | Drug: Mometasone furoate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
- Subjects must be between 18-65 years of age, of either sex and any race
- Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
- Subjects must be mometasone furoate naïve.
Key exclusion criteria (12 listed)
- Significant comorbid medical condition.
- Respiratory tract infection.
- Any contraindications according to mometasone furoate product monograph.
- Patients who have received antihistamine treatment within the last 5 days.
- Patients who have received corticosteroid treatment within the last 30 days.
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: Nasonex, SCH 32088Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days | Drug | Mometasone furoate |
| Mometasone furoateAlso: Nasonex, SCH 32088Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician | Drug | Mometasone furoate plus an oral antihistamine |
Primary outcome
To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.
Time frame: Day 28 and Day 56
2 secondary outcomes
Patient satisfaction with intranasal steroid monotherapy.
Time frame: Day 28
Potential benefit of an oral antihistamine in combination with an intranasal steroid
Time frame: Day 56
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.
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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 4 study testing Mometasone furoate in people with Rhinitis, Allergic, 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 4 inclusion and 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine. (time frame: Day 28 and Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.