Phase 3
N=127
Fluticasone Nasal Spray Patient Preference Study
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT00398476 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing — 72; 39; 9; 77 Participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- fluticasone propionate (FP) (Drug); fluticasone furoate (FF) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing |
72; 39; 9; 77; 35; 8 | 0.003 sig |
| SECONDARY Number of Participants With Preference for Scent/Odor in IAQ and DAQ |
62; 12; 71; 16; 27; 22 | <0.001 sig |
| SECONDARY Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ |
11; 16; 12; 20; 13; 25 | 0.255 |
| SECONDARY Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ |
14; 19; 11; 21; 12; 20 | 0.056 |
| SECONDARY Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ |
46; 10; 7; 2; 1; 0 | 0.845 |
| SECONDARY Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ |
56; 14; 2; 1; 4; 0 | 0.871 |
| SECONDARY Number of Participants Reported Product Have an Immediate Taste in IAQ |
98; 69; 10; 25; 7; 13 | <0.001 sig |
| SECONDARY Number of Participants Satisfied With an Immediate Taste in IAQ |
6; 12; 7; 9; 6; 9 | 0.592 |
| SECONDARY Number of Participants Reported Product Have an After Taste in DAQ |
90; 66; 22; 33; 7; 10 | <0.001 sig |
| SECONDARY Number of Participants Satisfied With an After Taste in DAQ |
7; 12; 8; 9; 3; 7 | 0.434 |
| SECONDARY Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ |
74; 69; 64; 55; 28; 29 | 0.797 |
| SECONDARY Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ |
61; 38; 63; 46; 42; 38 | <0.001 sig |
| SECONDARY Number of Participants Reported Product Feel Soothing in IAQ and DAQ |
28; 24; 26; 25; 28; 31 | 0.968 |
| SECONDARY Number of Participants Reported Product Make Want to Sneeze in IAQ |
87; 93; 17; 12; 8; 10 | 0.221 |
| SECONDARY Number of Participants Satisfied With Product in DAQ |
44; 34; 27; 23; 17; 27 | 0.205 |
| SECONDARY Number of Participants Reported Nasal Irritation in DAQ |
89; 78; 18; 21; 6; 10 | 0.108 |
| SECONDARY Number of Participants Reported Nasal Irritation Bothersome in DAQ |
7; 7; 15; 22; 9; 8 | 0.694 |
| SECONDARY Number of Participants Comply With Product if Prescribed in DAQ |
63; 45; 19; 26; 18; 16 | 0.020 sig |
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.
Eligibility Criteria
Inclusion Criteria
- allergic rhinitis
- literate
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00398476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.