Phase 3
N=365
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis
Rhinitis, Allergic, Perennial · Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01231464 ↗Enrolled (actual)
365
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS) — -4.226; -2.728 Points on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- fluticasone furoate nasal spray (Drug); placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS) |
-4.226; -2.728 | <0.0001 sig |
| SECONDARY Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy |
-4.2; -2.9 | — |
| SECONDARY Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living |
-1.2; -0.8 | — |
Summary
The objective of this study is to compare the efficacy and safety of Fluticasone Furoate Nasal Spray (FFNS), that is FFNS with placebo in Chinese adult and adolescent subjects with Allergic Rhinitis as AR. There are 3 phases, 2 to14 day run in, 2 week treatment, and 3 to 5 day follow up. After run in period, at least 360 subjects with AR ( ages of 12yrs and 65yrs, inclusive) will be randomised to receive FFNS 110ug once daily or placebo for 2 weeks. The primary endpoint is the change from baseline of reflective total nasal symptom score (rTNSS) during treatment period, and the secondary endpoints include mean change from baseline in nasal finding scores by rhinoscopy at completion of study treatment, and severity of overall inference in activities of daily living. Safety measures include AE (Adverse Event) reports, ECGs (Electrocardiograph), physical exams, vital signs, and nasal exam. In addition, reflective total ocular symptom score (rTOSS) will be measured as an explorative endpoint, only in the specific AR (Allergic Rhinitis) patients with severe ocular symptoms.
Eligibility Criteria
Inclusion Criteria
- Subjects can be enrolled when meeting all criteria as below.
- Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years
- Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)
- Subject must be symptomatic at screening and willing to maintain same environment throughout the study
- Ability to comply with study procedures
- Literate
Exclusion Criteria
- Subjects should be excluded when meeting one of criteria as below.
- Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
- Having complications of bacterial/viral infection of upper respiratory tract
- Having significant systemic diseases
- History of hypersensitivity to steroids and ingredients
- Pregnant women or under lactation
- Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
- Patients planning to travel outside the region
- Patients judged to be inappropriate by investigators
- Patients who participated in another study within 4 months before screening
- Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.
- allergy medications
- other medications that may affect allergic rhinitis or its symptoms
- any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole
Data sourced from ClinicalTrials.gov (NCT01231464). 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.