NAVIGATE I
Research type
Research Study
Full title
A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre 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
IRAS ID
160533
Contact name
Nirmal Kumar
Contact email
Sponsor organisation
OptiNose US, Inc.
Eudract number
2011-004886-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Nasal polyps are benign lesions arising from the mucus of the nasal sinuses or from the mucus of the nasal cavity. Nasal polyps are associated with chronic inflammation of the lining of the nasal passages and sinuses (chronic sinusitis). Patients with multiple and/or large polyps, may suffer partial or complete obstruction of the nasal passages and sinuses.
Currently, the most commonly used medications for the treatment of nasal polyps and their symptoms are part of a class of medications class called corticosteroids. Corticosteroids are natural substances found in the body that help fight inflammation. Fluticasone propionate is a man-made corticosteroid.
Fluticasone propionate spray is currently approved by the MHRA for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, and for the treatment of non-allergic rhinitis in adults and children 4 years of age and older. Fluticasone propionate nasal drops are approved by MHRA for the treatment of nasal polyps at doses of 400 and 800 µg per day.
The OPTINOSE FLUTICASONE device is an investigational (experimental) device. OPTINOSE FLUTICASONE is not approved for sale by the MHRA nor is it approved for sale in any other country.
The device has a nose piece and mouthpiece and a glass bottle that contains the study medication. The user administers the medication by inserting the nosepiece into one nostril and the mouthpiece into the mouth. The user then blows forcefully into the mouthpiece while depressing the bottom of the glass bottle. The medication is then propelled into the nasal cavity. The procedure is repeated in the other nostril. You will use the study medication twice a day, in the morning and at night. You will receive detailed instructions on the number of sprays and how to properly use the device.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1328
Date of REC Opinion
31 Oct 2014
REC opinion
Further Information Favourable Opinion