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Phase 4 Completed N=680 Randomized Double-blind Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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