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NCT01279057 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 727
- Enrollment target
NCT01279057: Completed Phase 3 study, sponsored by Sandoz.
NCT01279057 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 727 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01279057, a Phase 3 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 727 participants
- Enrollment target
Study Summary
This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.
Primary Outcome
Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scor
Interventions
- DRUG Placebo
- DRUG Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)
- DRUG Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 727 participants |
| Start Date | 2010-12-27 |
| Est. Completion | 2011-02-08 |
| Phase | Phase 3 |
What the finished NCT01279057 record still lists
NCT01279057 is an interventional study that assigns participants to a tested intervention. The registered 727 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01279057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01279057 about?
NCT01279057 is a clinical study titled "A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis". This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal sp...
What is the current status of trial NCT01279057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 727 participants. The study started on 2010-12-27. Estimated completion is 2011-02-08.
What interventions are being tested in trial NCT01279057?
The interventions under investigation include: Placebo (DRUG), Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) (DRUG), Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray (DRUG).
Who is sponsoring clinical trial NCT01279057?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01279057's enrollment target sits among peer trials
727 490th of 2000 higher than 1,511 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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