Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis

In brief

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps

Key facts

Study ID

NCT03960580

Run by

Optinose US Inc.

People needed

223

Starts

2019-06-06

Expected to finish

2022-05-04

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• men or women aged 18 years and older at baseline visit
• women of child bearing potential must be abstinent, or if sexually active,
• be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, 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 (Screening)
• must have a history of chronic sinusitis and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:
• nasal congestion
• nasal discharge (anterior and/or posterior nasal discharge)
• facial pain or pressure
• reduction or loss of smell
• endoscopic evidence of nasal mucosal disease, with edema or purulent discharge; or polyps/polypoid tissue <Grade 1 in middle meatus, bilaterally
• must have confirmatory evidence via a computed tomography(CT) scan of bilateral sinus disease (have at least 1 sinus on each side of nose with a Lund-Mackay score of ≥1)
• baseline CT scan must show a combined ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus
• must have at least moderate symptoms (as defined in protocol) of nasal congestion as reported by the subject, on average, for the 7-day period preceding Visit 1 (Screening) run-in
• must have an average morning score of at least 1.5 for congestion on the Nasal Symptom Scale (as defined in protocol) recorded on the subject diary over a 7-day period during the first 14 days of the single-blind run-in period
• must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
• Subjects with comorbid asthma or chronic obstructive pulmonary disorder (COPD) must be stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral or parenteral steroid use) within the 3 months before Visit 1 (Screening). 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 Visit 1 (Screening) with plans to continue use throughout the study.
• Subjects with aspirin-exacerbated respiratory disease, who have undergone aspirin desensitization and are receiving daily aspirin therapy, must be receiving therapy for at least 6 months prior to Visit 1.
• must be able to cease treatment with intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit.
• must be able to cease treatment with oral and nasal decongestants and antihistamines at Visit 1 (Screening)
• must be able to use the exhalation delivery system correctly; all subjects will be required to demonstrate correct use with the practice exhalation delivery system (EDS) at Visit 1 (Screening).
• 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
• inability to achieve bilateral nasal airflow
• is currently taking XHANCE®
• have previously used XHANCE® for more than 1 month and did not achieve an adequate symptomatic response
• the nasal/sinus anatomy prevents the accurate assessment of sinus volume via CT scan
• history of sinus or nasal surgery within 6 months before Visit 1 or has not healed from a prior sinus or nasal surgery
• have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinus is completely opacified and either the margins are expanded and/or thinned OR there are areas of complete bone resorption resulting in bony defect and extension of the "mass" into adjacent tissues), evidence of allergic fungal sinusitis, or evidence of complicated sinus disease (including, but not limited to, extension of inflammation outside of the sinuses and nasal cavity)
• have a paranasal sinus or nasal tumor
• have polyp grade ≥1 (polyp that is free on 5 sides and has a stalk) on either side of the nose as determined by the nasoendoscopy at screening
• have a nasal septum perforation
• have had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Screening)
• have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) on Visit 1 (Screening) nasal examination/nasoendoscopy
• have current, ongoing rhinitis medicamentosa (rebound rhinitis)
• have significant oral structural abnormalities (eg, a cleft palate)
• have a diagnosis of cystic fibrosis
• history of Churg-Strauss syndrome or dyskinetic ciliary syndromes
• symptom resolution or last dose of antibiotics for purulent nasal infection, acute sinusitis, or upper respiratory tract infection has not occurred before Visit 1 or was less than 4 weeks before the CT scan. 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 or steroids
• has used oral steroids in the past for treatment of chronic sinusitis and did not experience any relief of symptoms
• has a steroid eluting sinus stent still in place within 30 days of Visit 1
• allergy or hypersensitivity to any excipients in study drug
• exposure to any glucocorticoid treatment with potential for systemic effects (eg, oral, parenteral, intraarticular, or epidural steroids, high dose topical steroids) within 1 month before Visit 1 (Screening); except as noted in inclusion criteria for subjects with comorbid asthma or COPD
• have nasal candidiasis

Where it is running

• Sacramento Ear, Nose & Throat Surgical and Medical Group Inc — Folsom, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Veterans Administration Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Sacramento Ear, Nose & Throat Surgical and Medical Group — Roseville, California, United States
• Asthma and Allergy Associates — Colorado Springs, Colorado, United States
• Sher Allergy Specialists — Largo, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Best Clinical Trials — New Orleans, Louisiana, United States
• University of Missouri, Dept of Otorlaryngology — Columbia, Missouri, United States
• Mount Sinai Downtown Union Square — New York, New York, United States
• Northwell Health at ENT and Allergy Associates — New York, New York, United States
• Charlotte Eye Ear Nose and Throat Assoc., PA — Matthews, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• ENT & Allergy Partners, LLC — Summerville, South Carolina, United States
• Pasha Snoring & Sinus Center — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Allergy, Asthma & Sinus Center, SC — Greenfield, Wisconsin, United States
• Otopure Pty Ltd — Bella Vista, New South Wales, Australia
• Vale Medical Practice — Brookvale, New South Wales, Australia
• Australian Clinical Research Network — Maroubra, New South Wales, Australia
• Browns Plains Family Practice — Browns Plains, Queensland, Australia
• Casey Superclinic — Berwick, Victoria, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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