A Comparison of Fluticasone Furoate Nasal Spray (FFNS) versus OralFexofenadine in the Treatment of Seasonal Allergies.

Phase 1

Conditions: Seasonal Allergic Rhinitis
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2015-004873-34-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 680

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 996
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 elative 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study was to demonstrate that FFNS provides superior nighttime symptom relief over fexofenadine.;Secondary Objective: Secondary objectives were to demonstrate superior<br>efficacy of FFNS over fexofenadine in nasal and ocular symptoms. Other secondary objectives include demonstrating improvement in the subjects’ n octurnal rhinitis-related quality of life and<br>demonstrating comparable safety and tolerability of the active treatments.;Primary end point(s): Mean change from baseline in the nighttime symptoms score (NSS);Timepoint(s) of evaluation of this end point: Baseline and Weeks 1-2

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Nighttime, Daytime, and 24-hour reflective total nasal symptom scores (N-rTNSS, DrTNSS,<br>and 24-hour rTNSS, respectively)<br>• Nighttime, Daytime, and 24-hour reflective total ocular symptom scores (N-rTOSS, DrTOSS,<br>and 24-hour rTOSS, respectively)<br>• Pre-dose instantaneous total nasal and ocular symptom scores, (iTNSS and iTOSS, respectively)<br>• Peak inspiratory nasal flow (PNIF)<br>• Mean change from baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) results Safety was assessed in terms of the frequency and type of clinical adverse events (AEs);Timepoint(s) of evaluation of this end point: Mean change from baseline over the two-week treatment