Seasonal Allergic Rhinitis
Conditions
Interventions
Trade Name: Veramyst,Avamys,Allermist
Product Name: GW685698X
Product Code: GW685698X
Pharmaceutical Form: Nasal spray
INN or Proposed INN: FLUTICASONE FUROATE
CAS Number: 397864-44-7
Current Sponsor
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Nighttime, Daytime, and 24-hour reflective total nasal symptom scores (N-rTNSS, DrTNSS, and 24-hour rTNSS, respectively) • Nighttime, Daytime, and 24-hour reflective total ocular symptom scores (N-rTOSS, DrTOSS, and 24-hour rTOSS, respectively) • Pre-dose instantaneous total nasal and ocular symptom scores, (iTNSS and iTOSS, respectively) • Peak inspiratory nasal flow (PNIF) • 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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 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 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 | — |
Countries
United States
Contacts
Public ContactGSK Clinicial Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed