Phase 4
Completed N=680
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT00502775 ↗
Enrolled (actual)
680
Serious AEs
0.2%
Results posted
Mar 2009
Primary outcomePrimary: Mean Change From Baseline in the Nighttime Symptom Score (NSS) — -2.3; -3.1; -2.2 Score on a Scale — p=<0.001
Summary
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Nighttime Symptom Score (NSS) |
-2.3; -3.1; -2.2 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) |
-2.9; -4.1; -2.9 | — |
| SECONDARY Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) |
-3.0; -4.2; -2.9 | — |
| SECONDARY Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) |
-2.8; -4.1; -2.8 | — |
| SECONDARY Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) |
-2.3; -2.7; -2.2 | — |
| SECONDARY Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) |
-2.5; -2.9; -2.4 | — |
| SECONDARY Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) |
-2.3; -2.7; -2.2 | — |
| SECONDARY Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) |
-2.8; -4.1; -2.7 | — |
| SECONDARY Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) |
-2.2; -2.7; -2.2 | — |
| SECONDARY Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) |
4.8; 13.0; 2.2 | — |
| SECONDARY Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) |
2.3; 9.7; 0.3 | — |
| SECONDARY Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) |
-1.4; -2.0; -1.4 | — |
Eligibility Criteria
Inclusion criteria
- Informed consent
- Otherwise healthy outpatient with mountain cedar allergy
- Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
- Age 12 years or older at Visit 2
- Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
- Adequate exposure to mountain cedar pollen
- Ability to comply with study procedures
- Literate
Exclusion criteria
- Significant concomitant medical conditions
- Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
- Use of other allergy medications within specific timeframes relative to Visit 1
- Use of other medications that may affect allergic rhinitis or its symptoms
- Use of immunosuppressive medications eight weeks prior to screening and during the study
- Immunotherapy patients who are not stable on current dose
- Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
- Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
- Use of contact lenses
- Recent clinical trial/experimental medication experience within 30 days of Visit 1
- Subject previously failed the 21-day screen period or failed to complete the treatment period
- Positive or inconclusive pregnancy test or female who is breastfeeding
- Employee or relative affiliation with investigational site
- Current tobacco use
- Active chickenpox or measles or exposure in the last 3 weeks
Data sourced from ClinicalTrials.gov (NCT00502775). 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.