A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
Public ClinicalTrials.gov record NCT01916226. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Study 200165, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Compare the Efficacy of a 2-Week Treatment With Fluticasone Propionate Nasal Spray Versus Cetirizine in Adult Subjects With Seasonal Allergic Rhinitis (SAR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01916226
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 682 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2013 (Type not available)
- Primary completion
- Oct 1, 2013 (Actual)
- Completion
- Oct 17, 2013 (Actual)
- Last update posted
- Jun 20, 2018
2013
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Denver | Colorado | 80230 | — |
| GSK Investigational Site | Aventura | Florida | 33180 | — |
| GSK Investigational Site | Miami | Florida | 33173 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | — |
| GSK Investigational Site | Lenexa | Kansas | 66215 | — |
| GSK Investigational Site | Overland Park | Kansas | 66210 | — |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | — |
| GSK Investigational Site | Baltimore | Maryland | 21236 | — |
| GSK Investigational Site | Bethesda | Maryland | 20814 | — |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | — |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | — |
| GSK Investigational Site | Columbia | Missouri | 65203 | — |
| GSK Investigational Site | Rolla | Missouri | 65401 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Austin | Texas | 78731 | — |
| GSK Investigational Site | Austin | Texas | 78750 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Kerrville | Texas | 78028 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
| GSK Investigational Site | South Burlington | Vermont | 05403 | — |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01916226, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 20, 2018 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01916226 live on ClinicalTrials.gov.