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NCT01916226 · ClinicalTrials.gov registry record · Phase 4
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 682
- Enrollment target
NCT01916226: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01916226 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 682 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01916226, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 682 participants
- Enrollment target
Study Summary
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.
Primary Outcome
The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Base
Interventions
- DRUG Cetirizine
- DRUG FPNS
- DRUG FPNS Placebo
- DRUG Cetirizine Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2013-08-01 |
| Est. Completion | 2013-10-17 |
| Phase | Phase 4 |
What the finished NCT01916226 record still lists
NCT01916226 is an interventional study that assigns participants to a tested intervention. The registered 682 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 4 interventions - of which Cetirizine is the first listed.
NCT01916226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01916226 about?
NCT01916226 is a clinical study titled "A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis". This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal ...
What is the current status of trial NCT01916226?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 682 participants. The study started on 2013-08-01. Estimated completion is 2013-10-17.
What interventions are being tested in trial NCT01916226?
The interventions under investigation include: Cetirizine (DRUG), FPNS (DRUG), FPNS Placebo (DRUG), Cetirizine Placebo (DRUG).
Who is sponsoring clinical trial NCT01916226?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01916226's enrollment target sits among peer trials
682 119th of 2000 higher than 1,882 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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