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NCT01439815 · ClinicalTrials.gov registry record · Phase 4
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
A Phase 4 study, sponsored by ORA.
- Completed
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT01439815: Completed Phase 4 study, sponsored by ORA.
NCT01439815 is a Phase 4 study that has completed, run by ORA. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439815, a Phase 4 study, has completed, sponsored by ORA.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
Primary Outcome
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.
Interventions
- DRUG Fluticasone Propionate Nasal Spray
- DRUG Saline Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
What the finished NCT01439815 record still lists
NCT01439815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Propionate Nasal Spray is the first listed.
NCT01439815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439815 about?
NCT01439815 is a clinical study titled "An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo". The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
What is the current status of trial NCT01439815?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2011-09. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01439815?
The interventions under investigation include: Fluticasone Propionate Nasal Spray (DRUG), Saline Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT01439815?
This trial is sponsored by ORA, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01439815's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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