NCT01622569.
Trial name or title | 'Study evaluating the efficacy and safety of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day (bid) using a novel bi directional device in subjects with bilateral nasal polyposis followed by an 8‐week open‐label extension phase to assess safety' |
Methods | Double‐blind, parallel assignment, randomised controlled trial |
Participants | Adults with bilateral nasal polyposis |
Interventions | ‐ Fluticasone propionate 100 μg twice a day ‐ Fluticasone propionate 200 μg twice a day ‐ Fluticasone propionate 400 μg twice a day ‐ Matching placebo For 16 weeks |
Outcomes | ‐ Reduction of nasal congestion/obstruction symptoms ‐ Reduction in total polyp grade (sum of scores from both nasal cavities) No secondary outcomes were listed in the trial registry entry |
Starting date | 2013 |
Contact information | Optinose US Inc. No further details provided. |
Notes | Study has been listed as completed on the registry website (October 2015). No results are currently available. |