Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
Condition: Nasal Polyposis
MeSH terms: Nasal Polyps
Intervention: Fluticasone Propionate
Intervention description: OPN-375 186 μg BID, Delivered via exhalation delivery system
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety
      of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The
      total planned number of subjects is approximately 10, with each subject receiving OPN-375 186
      μg twice a day.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women aged 18 years and older at Visit 1 (Baseline/Day1)

          2. Women of child bearing potential must be abstinent, or if sexually active,

               1. be practicing an effective method of birth control (e.g., prescription oral
                  contraceptives, contraceptive injections, contraceptive patch, intrauterine
                  device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with
                  spermicidal foam, cream, or gel], or male partner sterilization) before entry and
                  throughout the study, or

               2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal
                  ligation, or otherwise be incapable of pregnancy), or

               3. be postmenopausal (amenorrhea for at least 1 year).

          3. Women of child-bearing potential must have a negative urine pregnancy test at Visit 1
             (Day 1/Baseline)

          4. Must have bilateral nasal polyposis with a grade of 2 or 3 in at least one side of the
             nasal cavity as determined by a nasal polyp grading scale score measured by
             nasoendoscopy at Visit 1 (Day 1/Baseline)

          5. Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)

          6. Must have been on an adequate dose of an intranasal corticosteroid (e.g. fluticasone
             propionate, fluticasone furoate, mometasone, triamcinolone, ciclosenide, budesonide,
             budesonide respules, beclomethasone) for at least 1 month, in the previous 3 months
             prior to Visit 1 (Day 1/Baseline)

          7. Subjects with comorbid asthma or chronic obstructive pulmonary disease (COPD) must be
             stable with no exacerbations (e.g., no emergency room visits, hospitalization, or oral
             or parenteral steroid use) within the 3 months before the screening visit. Inhaled
             corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of
             beclomethasone (or equivalent) for at least 3 months before screening with plans to
             continue use throughout the study

          8. Must be able to cease treatment with oral steroids, intranasal steroids, inhaled
             corticosteroids (except permitted doses listed above for asthma and COPD) at Visit 1
             (Day 1/Baseline)

          9. Must demonstrate correct use of the demo EDS

         10. Ability to read and speak English

         11. Must be capable, in the opinion of the investigator, of providing informed consent to
             participate in the study. Subjects must sign an informed consent document indicating
             that they understand the purpose of and procedures required for the study and are
             willing to participate in the study

        Exclusion Criteria:

          1. Women who are pregnant or lactating

          2. Inability to have each nasal cavity examined for any reason, including nasal septum
             deviation

          3. Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months

          4. Nasal septum perforation

          5. Has had more than 1 episode of epistaxis with frank bleeding in the month before Visit
             1 (Day 1/Baseline)

          6. Have evidence of significant mucosal injury or ulceration (e.g. exposed cartilage) on
             Visit 1 (Day 1/Baseline) nasal examination/nasoendoscopy

          7. History of sinus or nasal surgery within 3 months before Visit 1 (Day 1/Baseline). If
             >3 months subject should be fully recovered from surgery

          8. Current, ongoing rhinitis medicamentosa (rebound rhinitis)

          9. Have significant oral structural abnormalities, e.g., a cleft palate

         10. Diagnosis of cystic fibrosis

         11. History of Churg-Strauss syndrome or dyskinetic ciliary syndromes

         12. Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within
             2 weeks before Visit 1 (Day 1/Baseline). Potential subjects presenting with any of
             these infections may be rescreened 4 weeks after symptom resolution

         13. Planned sinonasal surgery during the period of the study

         14. Allergy, hypersensitivity, or contraindication to corticosteroids, steroids, or to any
             excipients in OPN-375

         15. Exposure to any glucocorticoid treatment with potential for systemic effects (e.g.,
             oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids)
             within 1 month before Visit 1 (Day 1/Baseline); except as noted in inclusion criteria
             for subjects with comorbid asthma or COPD

         16. Have nasal candidiasis at Visit 1 (Day 1/Baseline)

         17. History or current diagnosis of any form of glaucoma, ocular hypertension, or
             intraocular pressure elevation on any form of steroid therapy

         18. History or current diagnosis of the presence (in either eye) of a sub-capsular
             cataract

         19. Any serious or unstable concurrent disease, psychiatric disorder, or any significant
             condition that, in the opinion of the investigator could confound the results of the
             study or could interfere with the subject's participation or compliance in the study

         20. Recent (within 1 year of Visit 1 (Day 1/Baseline)) history of drug or alcohol abuse,
             or dependence that, in the opinion of the investigator could interfere with the
             subject's participation or compliance in the study

         21. Have participated in an investigational drug clinical trial within 30 days of Visit 1
             (Day 1/Baseline)

         22. Employees of the investigator or study center, with direct involvement in the proposed
             study or other studies under the direction of that investigator or study center, as
             well as family members of the employees or the investigator