Allergic RhinitisPhase 4NCT00817050
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
A Phase 4 study testing Mometasone Furoate Nasal Spray and fluticasone nasal spray in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Mometasone Furoate Nasal Spray and fluticasone nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2004to 1 Jan 2005
- 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
- Subject must have been 18-65 years of age, of either sex and any race.
- Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2.
- Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
- Subject must have understood and been able to adhere to the dosing and visit schedule.
Who cannot join
- Subject had used any investigational product within 30 days prior to enrollment.
- Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
- Subject was participating in any other clinical study(ies).
- Subject was using any nasal lavage fluid or spray.
- Subject was using any perfume during the study day.
- Subject was using any oral rinse during the study day.
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- Subject had used topical or oral nasal decongestants in the past 1 week.
- Subject had used a nasal corticosteroid in the previous 2 weeks.
- Subject had anosmia or ageusia (absence of the sense of smell or taste).
- Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
- Subject had a respiratory infection in the 2 weeks prior to testing.
About this study
Official title: A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over
This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.
- Conditions
- Allergic Rhinitis
- Being tested
- Mometasone Furoate Nasal Spray, fluticasone nasal spray
- 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 Furoate Nasal SprayDrug
Also called Nasonex, SCH 032088
One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray
fluticasone nasal sprayDrug
Also called Flonase®
One dose (2 sprays in each nostril) of fluticasone nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Nasonex Followed by Flonase | Active comparator | Not described Receives: Drug: Mometasone Furoate Nasal Spray; Drug: fluticasone nasal spray |
| Flonase Followed by Nasonex | Active comparator | Not described Receives: Drug: Mometasone Furoate Nasal Spray; Drug: fluticasone nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Measured: On the study day, after dose of each product
Secondary outcomes (5)
Subject rating for likely compliance with daily dosing,
Measured: On the study day, after dose of each product
Subject preference for glass or plastic bottle
Measured: On the study day, after dose of each product
Subject response to if they would want a prescription for their preferred product and if they would recommend the product
Measured: On the study day, after dose of each product
Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,
Measured: On the study day, after dose of each product
Subject ratings for individual product attributes
Measured: On the study day, after dose of each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study start1 Dec 2004
- Primary completion1 Jan 2005
- Study completion1 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT00817050
- Sponsor's protocol ID
- P04207
- Status last verified
- Feb 2022
- First submitted
- 5 Jan 2009
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
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 Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over
- ClinicalTrials.gov ID
- NCT00817050
- Acronym / sponsor ID
- P04207
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2004 (actual)
- Primary completion
- 1 Jan 2005 (actual)
- Study completion
- 1 Jan 2005 (actual)
- First posted
- 6 Jan 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 was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasonex Followed by Flonase | Active comparator | Drug: Mometasone Furoate Nasal Spray, Drug: fluticasone nasal spray |
| Flonase Followed by Nasonex | Active comparator | Drug: Mometasone Furoate Nasal Spray, Drug: fluticasone nasal spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must have been 18-65 years of age, of either sex and any race.
- Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2.
- Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
- Subject must have understood and been able to adhere to the dosing and visit schedule.
Key exclusion criteria (11 listed)
- Subject had used any investigational product within 30 days prior to enrollment.
- Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
- Subject was participating in any other clinical study(ies).
- Subject was using any nasal lavage fluid or spray.
- Subject was using any perfume during the study day.
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 Furoate Nasal SprayAlso: Nasonex, SCH 032088One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray | Drug | Flonase Followed by Nasonex, Nasonex Followed by Flonase |
| fluticasone nasal sprayAlso: Flonase®One dose (2 sprays in each nostril) of fluticasone nasal spray | Drug | Flonase Followed by Nasonex, Nasonex Followed by Flonase |
Primary outcome
Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Time frame: On the study day, after dose of each product
5 secondary outcomes
Subject rating for likely compliance with daily dosing,
Time frame: On the study day, after dose of each product
Subject preference for glass or plastic bottle
Time frame: On the study day, after dose of each product
Subject response to if they would want a prescription for their preferred product and if they would recommend the product
Time frame: On the study day, after dose of each product
Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,
Time frame: On the study day, after dose of each product
Subject ratings for individual product attributes
Time frame: On the study day, after dose of each product
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 Nasal Spray and fluticasone nasal spray in people with 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 4 inclusion and 11 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?
Overall product preference based on subjects' answer to the question "which product do you prefer overall" (time frame: On the study day, after dose of each product). 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.