Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

A 24-Week Open-Label Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

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.

Study Overview

• Status: Completed
• Conditions: Nasal Polyposis
• Intervention / Treatment: Drug: Fluticasone Propionate

Detailed Description

The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado SOM, Department of Otolaryngology
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OPN-375 186 mcg BID	Drug: Fluticasone Propionate; OPN-375 186 μg BID, Delivered via exhalation delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video	: Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps; Mild polyposis: polyps not reaching below the inferior border of the middle turbinate; Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests		24 Weeks, up to 30 days after last dose
Assessment for Safety Through Nasal Examination	Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum. If present, the nostril location is also recorded, along with severity, and if there is any relation to an injury or trauma	24 Weeks, up to 30 days after last dose
Assessment for Safety From Recording Vital Sign - Blood Pressure	Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)	Baseline, Week 12, Week 24
Assessment for Safety From Recording Vital Sign - Pulse	measure pulse in beats per minute (bpm)	Baseline, Week 12, Week 24
Assessment for Safety From the Collection of Information for Concomitant Medications Usage		24 Weeks, up to 30 days after last dose
Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities)	Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps; Mild polyposis: polyps not reaching below the inferior border of the middle turbinate; Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate	Week 24
Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade	Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps; Mild polyposis: polyps not reaching below the inferior border of the middle turbinate; Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate	Week 24
Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit	Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps; Mild polyposis: polyps not reaching below the inferior border of the middle turbinate; Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate	Week 24
Sinonasal Outcome Test 22 (SNOT-22) Total Score	SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst. 0: No problem; Very mild problem; Mild or slight problem; Moderate problem; Severe problem; Problem as bad as can be	Week 24
Sniffin' Sticks N-butanol Test	The Sniffin' Sticks n-butanol (Extended test) are used to investigate human olfactory performance by use of odor pens. the Extended Test consists of 3 different subtests: Threshold, Discrimination and Identification. the Threshold test is used to ascertain the patient's olfactory threshold. the Discrimination test requires the patient to differentiate smells. The Identification test requires the patient to identify everyday smells by means of a card with different choices. The result of this test is expressed as the sum of the results of the 3 subtests, the so called TDI score (threshold, discrimination, identification). A score of more than 30 rates as normal, a score of 30 or less indicates hyposmia and a score of 15 and below point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability.	Week 24
Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved	The Patient Global Impression of Change (PGIC), is a questionnaire where the patient rates the change in their symptoms. Score range is from 1 (very much improved) to 7 (very much worse)	Week 24

Collaborators and Investigators

• Sponsor: Optinose US Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2018
• Primary Completion (ACTUAL): February 22, 2019
• Study Completion (ACTUAL): February 22, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Polyps; Nasal Polyps; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: OPN-FLU-NP-3104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No