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NCT00435461 · ClinicalTrials.gov registry record · Phase 4
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
A Phase 4 study of Rhinitis, Allergic, Seasonal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,000
- Enrollment target
- 6
- Study locations
NCT00435461: Completed Phase 4 study of Rhinitis, Allergic, Seasonal, sponsored by GlaxoSmithKline.
NCT00435461 is a Phase 4 study of Rhinitis, Allergic, Seasonal that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,000 participants, above the 526-participant average among 3 other Rhinitis, Allergic, Seasonal trials with a reported enrollment target (90% higher). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435461, a Phase 4 study of Rhinitis, Allergic, Seasonal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,000 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Primary Outcome
The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NA
Conditions Studied
Interventions
- DRUG Fluticasone furoate and fexofenadine
Study Locations (6)
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Austin
- GSK Investigational Site - Kerrville
- GSK Investigational Site - New Braunfels
- GSK Investigational Site - San Antonio
- GSK Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2006-12-20 |
| Est. Completion | 2007-02-28 |
| Phase | Phase 4 |
What the finished NCT00435461 record still lists
NCT00435461 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 526-participant average among 3 other Rhinitis, Allergic, Seasonal trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Rhinitis, Allergic, Seasonal appearing as the primary indexed condition, and to 1 intervention - of which Fluticasone furoate and fexofenadine is the first listed.
NCT00435461 lists 6 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT00435461 about?
NCT00435461 is a clinical study titled "Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine". The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
What is the current status of trial NCT00435461?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,000 participants. The study started on 2006-12-20. Estimated completion is 2007-02-28.
What conditions does trial NCT00435461 study?
This clinical trial studies the following conditions: Rhinitis, Allergic, Seasonal.
What interventions are being tested in trial NCT00435461?
The interventions under investigation include: Fluticasone furoate and fexofenadine (DRUG).
Who is sponsoring clinical trial NCT00435461?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00435461 being conducted?
This trial has 6 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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