Last updated: 11/07/2018 05:53:50
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 RhinitisN/A
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent subjects with Allergic Rhinitis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline over the entire treatment period in the daily reflective total nasal symptom score (rTNSS)
Timeframe: Baseline through entire treatment period (Day 1 through Day 14)
Secondary outcomes:
Mean change from baseline (Visit 2) to the end of study (Visit 4/Early Withdrawal) in nasal finding score by rhinoscopy
Timeframe: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
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
Timeframe: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)
Interventions:
Drug: fluticasone furoate nasal spray
Drug: placebo
Enrollment:
365
Observational study model:
Not applicable
Primary completion date:
2010-20-05
Time perspective:
Not applicable
Clinical publications:
Han D, Liu S, Zhang Y, Wang J, Wang D, Kong W, Wang S, Cheng L, Zhang L and The Chinese Allergic Rhinitis Collaborative Research Group. Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis. Allergy Asthma Proc. 2011;32(6):472-481
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
September 2009 to May 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- Subjects can be enrolled when meeting all criteria as below.
- 1, Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years
- Subjects should be excluded when meeting one of criteria as below.
- 1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects can be enrolled when meeting all criteria as below. 1, Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years 2, 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) 3, Subject must be symptomatic at screening and willing to maintain same environment throughout the study 4, Ability to comply with study procedures 5, Literate
Exclusion criteria:
- Subjects should be excluded when meeting one of criteria as below. 1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis 2. Having complications of bacterial/viral infection of upper respiratory tract 3. Having significant systemic diseases 4. History of hypersensitivity to steroids and ingredients 5. Pregnant women or under lactation 6. Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1 7. Patients planning to travel outside the region 8. Patients judged to be inappropriate by investigators 9. Patients who participated in another study within 4 months before screening 10. Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g. a) allergy medications b) other medications that may affect allergic rhinitis or its symptoms c) any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-20-05
Actual study completion date
2010-20-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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