Rhinitis, Allergic, PerennialPhase 3NCT00398476
Fluticasone Nasal Spray Patient Preference Study
A Phase 3 study testing fluticasone propionate (FP) and fluticasone furoate (FF) in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 14 sites in United States.
Trial summary
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- fluticasone propionate (FP) and fluticasone furoate (FF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Dec 2006to 4 Dec 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- allergic rhinitis
- literate
Who cannot join
- clinical significant uncontrolled disease
- Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
- Use of intranasal medications <1 week
- Use of meds that significantly inhibit CYP4503A4
- Use of perfume or oral rinse on study day
- Allergy/intolerance to INS, antihistamines, or excipients
- Positive pregnancy test or female who is breastfeeding
- Affiliation with investigational site
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
GSK Investigational Site
Brick, New Jersey, 8724
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Lakewood, Colorado, 80401
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Skillman, New Jersey, 08558
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- fluticasone propionate (FP), fluticasone furoate (FF)
- Keywords
- taste, questionnaire, preference, attributes, odor, after taste, scent
- 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.
fluticasone propionate (FP)Drug
200 micrograms (mcg); an aqueous suspension of microfine FP
fluticasone furoate (FF)Drug
Also called fluticasone furoate, fluticasone propionate
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
| Study group | Role | What they receive |
|---|---|---|
| fluticasone propionate (FP) | Active comparator | 200 micrograms (mcg); an aqueous suspension of microfine FP Receives: Drug: fluticasone propionate (FP) |
| fluticasone furoate (FF) | Active comparator | 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF Receives: Drug: fluticasone furoate (FF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
Measured: Day 1
Secondary outcomes (17)
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Higher score indicated strong odor.
Measured: Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants Reported Product Have an Immediate Taste in IAQ
Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong.
Measured: Day 1
Number of Participants Satisfied With an Immediate Taste in IAQ
Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants Reported Product Have an After Taste in DAQ
Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.
Measured: Day 1
Number of Participants Satisfied With an After Taste in DAQ
Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? Participants specified their responses on a 6-point scale: 0: Very satisfied; 1: Moderately satisfied; 2: Somewhat satisfied; 3: Neither satisfied nor dissatisfied; 4: Somewhat dissatisfied; 5: Moderately dissatisfied; 6: Very dissatisfied.
Measured: Day 1
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? Participants specified their responses on a 6-point scale: 0: None; 1: Very slightly; 2: Slightly; 3: Neither slightly nor moderately; 4: Moderately; 5: Markedly; 6: Very markedly.
Measured: Day 1
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Measured: Day 1
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Measured: Day 1
Number of Participants Reported Product Make Want to Sneeze in IAQ
Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.
Measured: Day 1
Number of Participants Satisfied With Product in DAQ
Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Measured: Day 1
Number of Participants Reported Nasal Irritation in DAQ
Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.
Measured: Day 1
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Measured: Day 1
Number of Participants Comply With Product if Prescribed in DAQ
Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study start1 Dec 2006
- Primary completion4 Dec 2006
- Study completion4 Dec 2006
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.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Crossover
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398476
- Sponsor's protocol ID
- FFU108556
- Status last verified
- Jun 2017
- First submitted
- 9 Nov 2006
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00398476
- Acronym / sponsor ID
- FFU108556
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- taste, questionnaire, preference, attributes, odor, after taste, scent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 4 Dec 2006 (actual)
- Study completion
- 4 Dec 2006 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone propionate (FP) | Active comparator | Drug: fluticasone propionate (FP)200 micrograms (mcg); an aqueous suspension of microfine FP |
| fluticasone furoate (FF) | Active comparator | Drug: fluticasone furoate (FF)110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- allergic rhinitis
- literate
Key exclusion criteria (8 listed)
- clinical significant uncontrolled disease
- Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
- Use of intranasal medications <1 week
- Use of meds that significantly inhibit CYP4503A4
- Use of perfume or oral rinse on 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 |
|---|---|---|
| fluticasone propionate (FP)200 micrograms (mcg); an aqueous suspension of microfine FP | Drug | fluticasone propionate (FP) |
| fluticasone furoate (FF)Also: fluticasone furoate, fluticasone propionate110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF | Drug | fluticasone furoate (FF) |
Primary outcome
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Time frame: Day 1
An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
17 secondary outcomes
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
Time frame: Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
Time frame: Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
Time frame: Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
Time frame: Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
Time frame: Day 1
Number of Participants Reported Product Have an Immediate Taste in IAQ
Time frame: Day 1
Number of Participants Satisfied With an Immediate Taste in IAQ
Time frame: Day 1
Number of Participants Reported Product Have an After Taste in DAQ
Time frame: Day 1
Number of Participants Satisfied With an After Taste in DAQ
Time frame: Day 1
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
Time frame: Day 1
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
Time frame: Day 1
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
Time frame: Day 1
Number of Participants Reported Product Make Want to Sneeze in IAQ
Time frame: Day 1
Number of Participants Satisfied With Product in DAQ
Time frame: Day 1
Number of Participants Reported Nasal Irritation in DAQ
Time frame: Day 1
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Time frame: Day 1
Number of Participants Comply With Product if Prescribed in DAQ
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluticasone propionate (FP) and fluticasone furoate (FF) in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 14 sites in United States.
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 2 inclusion and 8 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 Jan 2018). 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?
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing (time frame: Day 1). 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 1 Mar 2018.