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

NCT03591068 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OPN-FLU-NP-3104
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

• 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 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate

  Week 24

Secondary Outcomes (11)

• 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

  24 Weeks, up to 30 days after last dose

• Assessment for Safety From Recording Vital Sign - Blood Pressure

  Baseline, Week 12, Week 24

• Assessment for Safety From Recording Vital Sign - Pulse

  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

Study Arms (1)

OPN-375 186 mcg BID

EXPERIMENTAL

Drug: Fluticasone Propionate

Interventions

Fluticasone Propionate DRUG

OPN-375 186 μg BID, Delivered via exhalation delivery system

OPN-375 186 mcg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 years and older at Visit 1 (Baseline/Day1)
• Women of child bearing potential must be abstinent, or if sexually active,
• 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
• be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
• be postmenopausal (amenorrhea for at least 1 year).
• Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline)
• 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)
• Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)
• 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)
• 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
• 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)
• Must demonstrate correct use of the demo EDS
• Ability to read and speak English
• 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

You may not qualify if:

• Women who are pregnant or lactating
• Inability to have each nasal cavity examined for any reason, including nasal septum deviation
• Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months
• Nasal septum perforation
• Has had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Day 1/Baseline)
• Have evidence of significant mucosal injury or ulceration (e.g. exposed cartilage) on Visit 1 (Day 1/Baseline) nasal examination/nasoendoscopy
• 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
• Current, ongoing rhinitis medicamentosa (rebound rhinitis)
• Have significant oral structural abnormalities, e.g., a cleft palate
• Diagnosis of cystic fibrosis
• History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
• 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
• Planned sinonasal surgery during the period of the study
• Allergy, hypersensitivity, or contraindication to corticosteroids, steroids, or to any excipients in OPN-375
• Have nasal candidiasis at Visit 1 (Day 1/Baseline)

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (2)

University of Colorado SOM, Department of Otolaryngology

Aurora, Colorado, 80045, United States

Location

University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jennifer Carothers
• Organization: Optinose

jennifer.carothers@optinose.com

908-432-3061

Study Officials

• Jennifer Carothers

  Optinose US Inc.

  STUDY DIRECTOR

• John Messina

  Optinose US Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 18, 2018
• Study Start: June 7, 2018
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Locations

US (2)