Seasonal allergic rhinitis (SAR)
Conditions
Interventions
Trade Name: Allermist,Veramyst,Avamys
Pharmaceutical Form:
INN or Proposed INN: FLUTICASONE FUROATE
CAS Number: 397864-44-7
Current Sponsor code: FLUTICASONE FUROATE
Concentration unit: µg microgram(
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 81 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 831 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
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
Design outcomes
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: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline over the two-week treatment period in the following: • 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: 24 hours | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed