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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    378
  • sponsor
    Optinose US Inc.
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Updated on 30 September 2020
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Investigator
Amy Berman
Primary Contact
Ear, Nose and Throat Associates at Greater Baltimore Medical Center (9.3 mi away) Contact
+62 other location
ct scan
edema
congestion
nasal congestion
rhinorrhea
asthma
nasal polyp
facial pain
anosmia

Summary

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 g twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) with or without nasal polyps.

Description

The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 g of OPN-375 (fluticasone propionate) with placebo in subjects with chronic sinusitis using the following co-primary endpoints:

  1. A change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at the end of Week 4.
  2. A change from baseline to Week 24/Early Termination (ET) in the average percent of the volume opacified in the ethmoid and maxillary sinuses.

Details
Treatment OPN-375
Clinical Study IdentifierNCT03781804
SponsorOptinose US Inc.
Last Modified on30 September 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Sinusitis?
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 before entry and throughout the study, or
be surgically sterile, 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, purulent discharge, or polyps 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 (as defined in protocol) recorded on the subject diary for a 7 days period of the single-blind run-in
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 g/day of beclomethasone (or equivalent) for at least 3 months before Visit 1 (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 the baseline 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 of 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

Exclusion Criteria

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 sinus mucocele or evidence of allergic fungal sinusitis
have a polyp extending outside the ostiomeatal complex/middle turbinate (anterior or inferior) that is below the inferior turbinate attachment 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 was less than 4 weeks prior to Visit 1 (Screening). 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, intra-articular, 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
history or current diagnosis of any form of glaucoma or ocular hypertension (intraocular pressure at screening of >21)
history of intraocular pressure elevation on any form of steroid therapy
history or current diagnosis of the presence (in either eye) of a sub-capsular cataract
history of immunodeficiency
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
have a positive drug screen or a recent (within 1 year of Visit 1 (Screening) 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
have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening)
have received mepolizumab (Nucala), reslizumab (Cinquair), dupilumab (Dupixent), omalizumab (Xolair), or benralizumab (Fasenra) within 6 months of Visit 1 (Screening)
is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole)
is an employee 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, or is a family member of the employee or the investigator
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