WHO ICTRP trial
A 24-week study to find out if the nasal spray containing fluticasone propionate…
EUCTR2019-000368-12-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-000368-12-GB |
|---|---|
| Public title | A 24-week study to find out if the nasal spray containing fluticasone propionate administered twice a day provides improvement and is safe for patients suffering from chronic sinusitis, and with or without nasal polyps. |
| Scientific title | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 µg of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps |
| Primary sponsor | OptiNose US, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;United Kingdom |
| Conditions | Chronic sinusitis MedDRA version: 20.1 Level: PT Classification code 10009137 Term: Chronic sinusitis System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09] |
| Interventions | Product Name: OptiNose Fluticasone Product Code: OPN-375 Pharmaceutical Form: Nasal spray, suspension INN or Proposed INN: Fluticasone propionate CAS Number: 80474-14-2 Current Sponsor code: OPN-375 Other descriptive name: FLUTICASONE… |
| Registration date | Jan 4, 2019 |
| Target size | 378 |
| Secondary IDs | OPN-FLU-CS-3205;110089 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: