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Chronic RhinosinusitisPhase 3NCT03781804

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

A Phase 3 study testing OPN-375 in people with Chronic Rhinosinusitis, run by Optinose US Inc. at 92 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis
What is being tested?
OPN-375
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
332 participants
Where
92 sitesin 8 countries
Study dates
27 Nov 2018to 19 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Potential subjects must meet the following criteria to enter this study:

  1. men or women aged 18 years and older at baseline visit
  2. women of childbearing potential must be abstinent, or if sexually active,
  3. 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
  4. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
  5. be postmenopausal (amenorrhea for at least 1 year)
  6. women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Screening)
  7. must have a history of chronic rhinosinusitis (CRS) 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
  1. endoscopic evidence of nasal mucosal disease, with edema, purulent discharge, or polyps in middle meatus, bilaterally, or presence of bilateral disease on a prior computed tomography (CT) scan performed within 14 days of Visit 1
  2. must have confirmatory evidence via a CT scan of bilateral sinus disease (have at least 1 sinus on each side of nose with a Lund-Mackay score of ≥1)
  3. baseline CT scan must show a combined ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus
  4. 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
  5. 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
  6. must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
  7. 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.
  8. 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.
  9. must be able to cease treatment with intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit
  10. must be able to cease treatment with oral and nasal decongestants and antihistamines at Visit 1 (Screening)
  11. must be able to use the exhalation delivery system (EDS) correctly; all subjects will be required to demonstrate correct use with the practice EDS at Visit 1 (Screening).
  12. 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.

Potential subjects who meet any of the following criteria will be excluded from entering this study:

  1. women who are pregnant or lactating
  2. inability to have each nasal cavity examined for any reason, including nasal septum deviation
  3. inability to achieve bilateral nasal airflow
  4. is currently taking XHANCE®
  5. have previously used XHANCE for more than 1 month and did not achieve an adequate symptomatic response
  6. the nasal/sinus anatomy prevents the accurate assessment of sinus volume via CT scan
  7. history of sinus or nasal surgery within 6 months before Visit 1 or has not healed from a prior sinus or nasal surgery
  8. 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)
  9. have a paranasal sinus or nasal tumor
  10. 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
  11. have a nasal septum perforation
  12. have had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Screening)
  13. have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) on Visit 1 (Screening) nasal examination/nasoendoscopy
  14. have current, ongoing rhinitis medicamentosa (rebound rhinitis)
  15. have significant oral structural abnormalities (eg, a cleft palate)
  16. have a diagnosis of cystic fibrosis
  17. history of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or dyskinetic ciliary syndromes
  18. Symptom resolution or last dose of antibiotics for purulent nasal infection, acute sinusitis, or upper respiratory tract infection, influenza, or SARS-CoV-2 (COVID-19) 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.
  19. planned sinonasal surgery during the period of the study
  20. allergy, hypersensitivity, or contraindication to corticosteroids or steroids
  21. has used oral steroids in the past for treatment of CRS and did not experience any relief of symptoms
  22. has a steroid eluting sinus stent still in place within 30 days of Visit 1
  23. allergy or hypersensitivity to any excipients in study drug
  24. 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
  25. have nasal candidiasis
  26. history or current diagnosis of any form of glaucoma or ocular hypertension
  27. history of intraocular pressure (IOP) elevation on any form of steroid therapy
  28. history or current diagnosis of the presence (in either eye) of a cataract unless both natural intraocular lenses have been removed
  29. history of immunodeficiency
  30. 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
  31. 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
  32. have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening)
  33. have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1 (Screening)
  34. is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole, cobicistat)
  35. 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
  36. Patients who report unexplained worsening of vision within the past 3 months (e.g. difficulty reading or seeing traffic signs from a distance.). A diagnosis of presbyopia established by an eye doctor is not exclusionary

Trial locations and contacts

92 sites in 8 countries.

92 sites in 8 countries

United States46 sites

  • Emory University MOT

    Atlanta, Georgia, 30308

  • Kern Research

    Bakersfield, California, 93301

  • John Hopkins Hospital

    Baltimore, Maryland, 21287

  • Bellingham Asthma, Allergy & Immunology Clinic

    Bellingham, Washington, 98225

  • Specialty Physician Associates

    Bethlehem, Pennsylvania, 18017

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Allergy Asthma & Immunology Relief of Charlotte

    Charlotte, North Carolina, 28204

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago

    Chicago, Illinois, 60637

  • Colorado ENT & Allergy

    Colorado Springs, Colorado, 80909

  • University of Missouri, Dept of Otorlaryngology

    Columbia, Missouri, 65212

  • Iowa Head & Neck

    Des Moines, Iowa, 50312-3505

  • Sacramento Ear, Nose & Throat Surgical and Medical Group Inc

    Folsom, California, 95630

  • AZ Allergy & Immunology Research

    Gilbert, Arizona, 85234

  • University of TX Health Science Ctr at Houston

    Houston, Texas, 77030

  • Allergy & Asthma Specialists Medical Group

    Huntington Beach, California, 92647

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Asthma, Allergy, and Immunology Associates, PC

    Lincoln, Nebraska, 68505

  • Jonathan Corren, MD, Clinical Research Division

    Los Angeles, California, 90025

  • Kentuckiana Ear Nose & Throat

    Louisville, Kentucky, 40205

  • Advanced ENT and Allergy

    New Albany, Indiana, 47150

  • Yale School of Medicine Section of Otolaryngology

    New Haven, Connecticut, 06519

  • ENT and Allergy Associates

    New Hyde Park, New York, 11042

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Downtown Union Square

    New York, New York, 10003

  • Madison ENT and Facial Plastic Surgery

    New York, New York, 10016

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Midwest Allergy Sinus Asthma

    Normal, Illinois, 61761

  • National Allergy and Asthma Research

    North Charleston, South Carolina, 29420

  • Atlantic Research Center

    Ocean City, New Jersey, 07712

  • Allergy Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Hospital at the University of PA

    Philadelphia, Pennsylvania, 19104

  • Northwest Research Center

    Portland, Oregon, 97202

  • Sacramento Ear, Nose & Throat

    Roseville, California, 95661

  • UC Davis Medical Center

    Sacramento, California, 95817

  • St. Cloud Ear, Nose & Throat

    Saint Cloud, Minnesota, 56303

  • Intermountain Ear, Nose & Throat

    Salt Lake City, Utah, 84102

  • STAAMP Research, LLC

    San Antonio, Texas, 78229

  • Allergy and Asthma Associates of Santa Clara Valley

    San Jose, California, 95117

  • Spokane ENT

    Spokane Valley, Washington, 99201

  • Chrysallis Clinical Research

    St. George, Utah, 84790

  • Breathe Clear Institute

    Torrance, California, 90503

  • Ear, Nose and Throat Associates at Greater Baltimore Medical Center

    Towson, Maryland, 21204

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

Poland15 sites

  • ReumaClinic

    Bialystok, 15-181

  • Przychodnia "Narutowicza"

    Inowrocław, 88-100

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Jarosław Ślifirski Indywidualna Praktyka Lekarska

    Kęty, Lesser Poland Voivodeship, 32-650

  • Centrum Medyczne All Med - Krakow

    Krakow, 30-033

  • Medical Center Woś i Piwowarczyk

    Krakow, 31-572

  • Mini Clinic Paweł Białogłowski

    Łańcut, Podkarpackie Voivodeship, 37-100

  • Centrum Alergologii

    Lublin, 20-552

  • NZOZ Imedica

    Poznan, Wielkopolska, 60-537

  • Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie

    Strzelce Opolskie, 47-100

  • NZOZ "Ignis" dr med. Alicja Łobińska

    Świdnik, 21-040

  • NZOZ Przychodnia Medycyny Rodzinnej

    Świętochłowice, 41-600

  • NZOZ Centrum Medyczne LiMED

    Tarnowskie Góry, Silesian Voivodeship, 42-600

  • Centrum Medyczne Biotamed

    Wieliczka, Lesser Poland Voivodeship, 32-020

  • Medicus Sp z o.o.

    Wroclaw, Lower Silesian Voivodeship, 50-224

Other trials in Poland

Russia7 sites

  • I.M. Sechenov First Moscow State Medical University-University Hospital No.1 - Ear, Nose, and Throat Clinic

    Moscow, Moskovskaya Obl., 119435

  • Moscow Regional Scientific Research Clinical Institute n.a. M.F. Vladimirsky (MONIKI)

    Moscow, Moskovskaya Obl., 129110

  • Central Clinical Hospital with Polyclinic" Office of Affairs of the President of the Russian Federation

    Moscow, 121359

  • Saint-Petersburg State Medical University n.a. I.P. Pavlov

    Saint Petersburg, Sankt-Peterburg, 197022

  • Saint-Petersburg Institute of Ear, Nose, Throat, and Speech (The RSFSR Ministry of Health)

    Saint Petersburg, 190013

  • Smolensk, "Uromed"

    Smolensk, Smolenskaya Obl, 214031

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, Yaroslavskaya Obl., 150062

Other trials in Russia

Bulgaria6 sites

  • UMHAT - Kaspela EOOD

    Plovdiv, 4002

  • MC Iskar

    Sofia, 1000

  • Multiprofile Hospital for Active Treatment Serdika

    Sofia, 1303

  • MC Pirogov

    Sofia, 1606

  • The Military Medical Academy (MHAT)

    Sofia, 1606

  • Мinistry of Interior - Medical Institute

    Sofia, 1606

Other trials in Bulgaria

Georgia5 sites

  • Ltd Acad. Fridon Todua Medical Center

    Tbilisi, 0112

  • Ltd Israel-Georgian Medical Research Clinic - Helsicore

    Tbilisi, 0112

  • JSC Curatio

    Tbilisi, 0114

  • Ltd Aversi Clinic

    Tbilisi, 0160

  • Ltd Simon Khechinashvili University Hospital

    Tbilisi, 0179

Other trials in Georgia

Sweden5 sites

  • ONH Kliniken Sahlgrenska Universitetsynkhiset

    Gothenburg, Vastra Gotaland Lan, 413 45

  • Helsingborg Hospital

    Helsingborg, Sverige, 25187

  • ONH Klinikun Skane Universitetssjukhuset (Lund - Oron- Nas- Och Halskliniken)

    Lund, Skåne County, 222 41

  • Karolinska University Hospital

    Stockholm, Stockholm County, 171 76

  • Sofiahemmet Hospital

    Stockholm, 114 28

Other trials in Sweden

United Kingdom5 sites

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Darlington Memorial Hospital

    Darlington, DL3 6HX

  • Lister Hospital

    Stevenage, SG1 4AB

  • Stockport NHS Foundation Trust (Stepping Hill Hospital Base)

    Stockport, SK2 7JE

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    Wigan, WN1 2NN

Other trials in United Kingdom

Canada3 sites

  • St. Joseph's Healthcare London

    London, Ontario, N6A 4V2

  • CHU de Quebec, pavillon Hopital Saint- Sacrement

    Québec, G1S 4L8

  • University of British Columbia and Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

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 (CS) with or without nasal polyps.

Read the detailed description

The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate) with placebo in subjects with chronic rhinosinusitis 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.
Being tested
OPN-375

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPN-375Drug

    OPN-375, BID

Study groups in NCT03781804
Study groupRoleWhat they receive
OPN-375 186 μg BIDActive comparatorOPN-375 186 μg BID x 24 Weeks
Receives: Drug: OPN-375
OPN-375 372 μg BIDActive comparatorOPN-375 372 μg BID x 24 Weeks
Receives: Drug: OPN-375
PlaceboPlacebo comparatorMatching Placebo BID x 24 Weeks
Receives: Drug: OPN-375

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4

    Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.

    Measured: 4 Weeks

  2. Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses

    Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.

    Measured: Baseline, Week 24

Secondary outcomes (33)

  1. Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains

    The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.

    Measured: Week 24

  2. Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)

    Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.

    Measured: Week 12

  3. Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores

    Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.

    Measured: 12 Weeks

  4. Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores

    Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).

    Measured: 12 Weeks

  5. Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores

    Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.

    Measured: 12 Weeks

  6. Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores

    Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.

    The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).

    Measured: 12 Weeks

  7. Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations

    Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.

    Measured: 24 Weeks

  8. Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score

    Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.

    Measured: Baseline, Week 24

  9. Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined

    Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).

    The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 [Wk 24] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).

    Measured: 24 Weeks

  10. Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs

    Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).

    Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).

    Measured: Week 24

  11. Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment

    Measured: Baseline, Week 24

  12. Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment

    Measured: Baseline, Week 24

  13. Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations

    Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.

    Measured: 24 Weeks

  14. Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score

    Zeinrich Modification of the Lund-Mackay Staging System:

    Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.

    Measured: Baseline, Week 24

  15. Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined

    Zeinrich Modification of the Lund-Mackay Staging System:

    Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.

    Measured: Baseline, Week 24

  16. Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs

    Zeinrich Modification of the Lund-Mackay Staging System:

    Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).

    Measured: Baseline, Week 24

  17. Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations

    Zeinrich Modification of the Lund-Mackay Staging System:

    Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%

    Measured: Baseline, Week 24

  18. Time Comparison to First Acute Exacerbation of Chronic Sinusitis

    Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment

    Measured: 24 Weeks

  19. Percentage of Subjects Requiring Rescue Medication After Week 4

    Recording of each dose of approved rescue medication after the Week 4 visit through Week 12

    Measured: 8 Weeks

  20. Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 "component" scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.

    Measured: 12 Weeks, 24 Weeks

  21. Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)

    Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse

    Measured: Week 4, Week 24

  22. Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)

    The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.

    Measured: Week 24

  23. Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)

    Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.

    Measured: 24 Weeks

  24. Change in the SF-36v2 Physical Composite Score (PCS)

    Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.

    Measured: 24 Weeks

  25. Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)

    The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.

    Measured: 24 Weeks

  26. Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)

    The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.

    Measured: 24 Weeks

  27. Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™

    The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.

    Measured: 24 Weeks

  28. Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)

    The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).

    Measured: 24 Weeks

  29. Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument

    The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).

    Measured: 24 Weeks

  30. Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery

    Percentage of subjects indicating that they are willing to consider Sinus Surgery

    Measured: Baseline, Week 24

  31. Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention

    Percentage of Subjects who meet the minimal objective criteria for surgical intervention

    Measured: Baseline, Week 24

  32. Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery

    Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.

    Measured: Week 24

  33. Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).

    The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. Values for this outcome are reported as the change in relative absenteeism (the percentage of productivity at work) from baseline to Week 24.

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start27 Nov 2018
  3. Primary completion19 Jan 2022
  4. Study completion19 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781804
Sponsor's protocol ID
OPN-FLU-CS-3205
Status last verified
May 2024
First submitted
18 Dec 2018
Last updated
29 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Peters AT, Adappa ND, Chandra RK, Davis GE, Deck D, Mahdavinia M, Patel ZM, Schlosser RJ, Sindwani R, Soler ZM, White MPHAA, Wise SK, Palmer JN. Exhalation Delivery System with Fluticasone in Chronic Rhinosinusitis by Eosinophil, Asthma, and Allergy Status. Ann Allergy Asthma Immunol. 2026 Sep 3:S1081-1206(26)00423-0. doi: 10.1016/j.anai.2026.08.024. Online ahead of print.

    PubMed 42692406

  • Schlosser RJ, Adappa ND, Chandra RK, Davis GE, Mahdavinia M, Messina J, Patel ZM, Peters AT, Sindwani R, Soler ZM, White AA, Wise SK, Palmer JN. Efficacy of Exhalation Delivery System With Fluticasone in Chronic Rhinosinusitis With Versus Without Polyps. Otolaryngol Head Neck Surg. 2026 Aug 26. doi: 10.1002/ohn.70406. Online ahead of print.

    PubMed 42647052

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OPN-375 in people with Chronic Rhinosinusitis, run by Optinose US Inc. at 92 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Poland, Russia, Bulgaria, Georgia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03781804, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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