treatment of bilateral nasal polyposis
Conditions
Interventions
Product Name: Rhinosinusitis Fluticasone Combination Product (RFCP)
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: fluticasone propionate
CAS Number: 80474-14-2
Concentration unit
Sponsors
OptiNose UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 18 and 65 years of age 2. Subjects must have bilateral nasal polyposis grade 1 or 2 (0-3 Lildholdt's scale) graded on nasendoscopy 3. Women of childbearing age must be neither pregnant nor lactating. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception(which include oral contraception, injectable or implantable methods, intrauterine devices, properly used barrier contraception, or abstinence). 4. No clinically significant abnormal serum biochemistry, haematology and urine examination values on screening 5. Subjects must be available to complete the study 6. In clinician's judgement, subjects must be fit and able to participate in the study 7. Able to provide written informed consent 8. To be included in the randomisation subjects must have correctly completed the daily diary during the run-in period (the diary must have been substantially completed on at least 5 out of each 7 day period) 9. Subject must be willing and able to comply with the study requirements as described in the protocol (and its amendments if any) 10. Subjects must have verified airflow through both nostrils and an ability to close their soft palate 11. Subject must have the ability to create bi-directional flow using a placebo OptiNose device with a nasal outflow of >20 L/min 12. Subject must have the ability to trigger the Breath Actuation Mechanism of an OptiNose device in accordance with the Instructions For Use Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who have had surgical treatment for nasal polyps during the previous 3 months 2. Subjects with a diagnosis of cystic fibrosis 3. Subjects with a purulent nasal infection,allergic rhinitis, or other disease likely to interfere with the study parameters, evidence of any serious or unstable concurrent disease or psychological disorder. Subjects presenting with a purulent nasal infection may be rescreened in 2-4 weeks. 4.Those with hypersensitivity or contraindication to steroids or any excipients. 5.Subjects who have received depot or oral steroids during the previous 3 months. 6.Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma. 7.Subjects taking inhaled steroids who have not been on a stable dose for 3 months or more. 8.The subject has taken a potent CYP3A-inhibitor (see Section 5.9.2 and Appendix 2 of study protocol) within 31 days prior to the Screening Visit 9.Subjects who are unable to cease treatment with intranasal steroids, or intranasal sodium cromoglycate, decongestants or antihistamines at the Screening Visit. 10.Subjects currently receiving leukotriene receptor antagonists, nasal atropine or ipratropium bromide, beta blockers or neuroleptics. 11.Subjects who are unable to cease treatment with saline rinsing at the Screening Visit. 12.Subjects using devices that dilate the nostrils to improve nasal breathing. 13.A recent or clinically significant history of drug or alcohol abuse. 14.Subjects with an inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function). 15.Subjects with a cleft palate. 16.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 |
|---|---|
| Main Objective: To determine the efficacy of fluticasone propionate delivered by the OptiNose device in patients with bilateral polyposis compared with placebo;Secondary Objective: To investigate the safety and tolerability of fluticasone propionate delivered by the OptiNose device;Primary end point(s): -Change from baseline to each visit in bilateral polyp size using the Lildholdt’s Scale assessed by nasendoscopy -Change from baseline to each visit in bilateral polyp size using lateral imaging assessed by nasendoscopy -Change from baseline to each visit in peak nasal inspiratory flow (PNIF) -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 -Use of rescue medication -Subject Global Rating Scale | — |
Countries
Czech Republic
Outcome results
None listed