Phase 4
Completed N=936
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT00435461 ↗
Enrolled (actual)
936
Serious AEs
0.1%
Results posted
Feb 2018
Primary outcomePrimary: Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) — -1.9; -2.9; -2.0; -0.6 Scores on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) |
-1.9; -2.9; -2.0; -0.6; -0.9; -0.6 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score |
-2.5; -3.7; -2.7; -0.6; -0.9; -0.7 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS |
-2.6; -3.7; -3.0; -0.7; -0.9; -0.8 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score |
-2.5; -3.6; -2.8; -0.6; -0.9; -0.7 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) |
-2; -2.5; -2.2; -0.7; -0.9; -0.8 | 0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) |
-2.2; -2.6; -2.4; -0.8; -0.9; -0.8 | 0.007 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) |
-2.0; -2.5; -2.2; -0.7; -0.9; -0.8 | 0.003 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) |
-2.3; -3.6; -2.6; -0.6; -0.8; -0.6 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) |
1.7; 9.9; 1.4; 0.2; 7.1; 1.3 | <0.001 sig |
| SECONDARY Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) |
-1.3; -1.9; -1.5; -1.2; -1.9; -1.5 | <0.001 sig |
Eligibility Criteria
Inclusion criteria
- Informed consent.
- Outpatient.
- Females of child-bearing potential must use appropriate contraception.
- Diagnosis of seasonal allergic rhinitis to mountain cedar.
- Adequate exposure to allergen.
- Able to comply with study procedures.
- Literate.
Exclusion criteria
- Significant concomitant medical condition.
- Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
- Positive pregnancy test.
- Allergy to any component of the investigational product.
- Tobacco use
- Contact lens use
- Has chickenpox or measles or recent exposure
- Other clinical trial drug exposure in last 30 days
- Affiliation with clinic site
Data sourced from ClinicalTrials.gov (NCT00435461). 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. Informational only — not medical advice.