chronic rhinosinusitis
Conditions
Interventions
Half of the group (20 subjects) will receive 400 micrograms twice dialy (total
daily dose of 800 micrograms) of the investigated productl (Fluticasone
Propionate) and the other half will receive pla
Sponsors
OptiNose UK Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male and female subjects aged between 18 and 65 years of age. - Subjects must have chronic rhinosinusitis which is defined as at least 12 weeks history of two or more of: * Blockage/congestion * Discharge: anterior/post nasal drip * Facial pain/pressured * Reduction or loss of smell And either: * Mucopurulent discharge from the middle meatus or * Edema/mucosal obstruction primarily in the middle meatus. - Subjects must have no clinically significant abnormal serum biochemistry, haematology and urine examination values on screening. - Subjects must have verified airflow through both nostrils and an ability to close their soft palate. - The subject must have the ability to create bi-directional flow using a placebo OptiNose device with a nasal outflow of >20 L/min. - The subject must have the ability to trigger the Breath Actuation Mechanism of an OptiNose device in accordance with the Instructions For Use.
Exclusion criteria
Exclusion criteria: - Subjects who have visible pedunculated polyps on nasal endoscopy. - Subjects who have undergone surgical treatment for nasal polyps during the previous 3 months. - Subjects with a diagnosis of cystic fibrosis. - Subjects with other disease likely to interfere with the study parameters, evidence of any serious or unstable concurrent disease or psychological disorder. - A hypersensitivity or contraindication to steroids or any excipients. - Subjects who have received depot or oral steroids during the previous 3 months. - Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma. - Subjects taking inhaled steroids who have not been on a stable dose for 3 months or more. - Subjects who are unable to cease treatment with intranasal steroids, or intranasal sodium cromoglycate, decongestants or antihistamines at the Screening Visit. - Subjects currently receiving leukotriene receptor antagonists, nasal atropine or ipratropium bromide, beta blockers or neuroleptics. - Subjects who are unable to cease treatment with saline rinsing at the Screening Visit. - Subjects using devices that dilate the nostrils to improve nasal breathing. - Subjects being treated with ritonavir or other potent CYP3A inhibitors as listed in Appendix 2 of the protocol due to the potential for greatly increased fluticasone plasma concentrations. - Subjects with a history of operations where metal objects were used and retained in the body or those with a pacemaker or other implants e.g. cochlear implants and artificial heart valves. - Subjects with a history of a penetrating injury to the eye with a metal object or those who have worked with metal at high speed. - A history of drug or alcohol abuse. - Subjects with an inability to communicate well with the investigator (i.e. language problem,poor mental development or impaired cerebral function) - Subjects with a cleft palate. - Subjects who have participated in a New Chemical Entity study within the previous 16 weeks or a marketed drug study within the previous 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Parameters: ·Change from baseline to last visit (Visit 5) in Visual Analogue Scale (VAS) overall symptom score for chronic rhinosinusitis. Change from baseline to other timepoints will be a secondary endpoint. ·Change from baseline to each visit in the Clinician assessment of nasal blockage on nasendoscopy using the Lund and Mackay scoring system. ·Monthly change from baseline (mean daily score over the last 7 days of run-in) in morning and evening combined averaged symptom score for each month from patient Diary. ·Change from baseline to each visit in the Rhinosinusitis Outcome Measure 31 (RSOM-31). ·The change from baseline in the inflammatory mucosa measured using magnetic resonance imaging (MRI) at 12 weeks. ·Change from baseline to each visit in nasal volume and cross-sectional area measured using acoustic rhinometry. ·Change from baseline to each visit in peak nasal inspiratory flow (PNIF) ·Use of rescue medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Parameters: ·Adverse events ·Vital signs ·Clinical laboratory tests (hematology, clinical chemistry, urinalysis) ·Morning plasma cortisol concentration ·physical examination. | — |
Countries
Netherlands
Outcome results
None listed