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

NCT03781804 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OPN-FLU-CS-3205
• Study Type: interventional
• Target: 332
• Locations: 8 countries
• Sites: 92

Brief 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.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (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) 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.

  4 Weeks

• 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%.

  Baseline, Week 24

Secondary Outcomes (33)

• 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

  Week 24

• 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)

  Week 12

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

  12 Weeks

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

  12 Weeks

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

  12 Weeks

Other Outcomes (6)

• Evaluation of Safety by Recording the Severity of Adverse Events (AEs)

  24 Weeks

• Evaluation of Safety-Nasal Examination

  24 Weeks

• Evaluation of Safety Measuring Vital Signs- Blood Pressure

  24 Weeks

Study Arms (3)

OPN-375 186 μg BID

ACTIVE COMPARATOR

OPN-375 186 μg BID x 24 Weeks

Drug: OPN-375

OPN-375 372 μg BID

ACTIVE COMPARATOR

OPN-375 372 μg BID x 24 Weeks

Drug: OPN-375

Placebo

PLACEBO COMPARATOR

Matching Placebo BID x 24 Weeks

Drug: OPN-375

Interventions

OPN-375 DRUG

OPN-375, BID

OPN-375 186 μg BID; OPN-375 372 μg BID; Placebo

Eligibility Criteria

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

You may qualify if:

• have nasal candidiasis
• history or current diagnosis of any form of glaucoma or ocular hypertension
• history of intraocular pressure (IOP) elevation on any form of steroid therapy
• history or current diagnosis of the presence (in either eye) of a cataract unless both natural intraocular lenses have been removed
• 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, cobicistat)
• 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

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (92)

AZ Allergy & Immunology Research

Gilbert, Arizona, 85234, United States

Location

Kern Research

Bakersfield, California, 93301, United States

Location

Sacramento Ear, Nose & Throat Surgical and Medical Group Inc

Folsom, California, 95630, United States

Location

Allergy & Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Jonathan Corren, MD, Clinical Research Division

Los Angeles, California, 90025, United States

Location

Sacramento Ear, Nose & Throat

Roseville, California, 95661, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Allergy and Asthma Associates of Santa Clara Valley

San Jose, California, 95117, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

Colorado ENT & Allergy

Colorado Springs, Colorado, 80909, United States

Location

Yale School of Medicine Section of Otolaryngology

New Haven, Connecticut, 06519, United States

Location

Emory University MOT

Atlanta, Georgia, 30308, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Midwest Allergy Sinus Asthma

Normal, Illinois, 61761, United States

Location

Advanced ENT and Allergy

New Albany, Indiana, 47150, United States

Location

Iowa Head & Neck

Des Moines, Iowa, 50312-3505, United States

Location

Kentuckiana Ear Nose & Throat

Louisville, Kentucky, 40205, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Ear, Nose and Throat Associates at Greater Baltimore Medical Center

Towson, Maryland, 21204, United States

Location

St. Cloud Ear, Nose & Throat

Saint Cloud, Minnesota, 56303, United States

Location

University of Missouri, Dept of Otorlaryngology

Columbia, Missouri, 65212, United States

Location

Asthma, Allergy, and Immunology Associates, PC

Lincoln, Nebraska, 68505, United States

Location

Atlantic Research Center

Ocean City, New Jersey, 07712, United States

Location

ENT and Allergy Associates

New Hyde Park, New York, 11042, United States

Location

Mount Sinai Downtown Union Square

New York, New York, 10003, United States

Location

Madison ENT and Facial Plastic Surgery

New York, New York, 10016, United States

Location

Allergy Asthma & Immunology Relief of Charlotte

Charlotte, North Carolina, 28204, United States

Location

Allergy Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Hospital at the University of PA

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

National Allergy and Asthma Research

North Charleston, South Carolina, 29420, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

University of TX Health Science Ctr at Houston

Houston, Texas, 77030, United States

Location

STAAMP Research, LLC

San Antonio, Texas, 78229, United States

Location

Intermountain Ear, Nose & Throat

Salt Lake City, Utah, 84102, United States

Location

Chrysallis Clinical Research

St. George, Utah, 84790, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Spokane ENT

Spokane Valley, Washington, 99201, United States

Location

UMHAT - Kaspela EOOD

Plovdiv, 4002, Bulgaria

Location

MC Iskar

Sofia, 1000, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdika

Sofia, 1303, Bulgaria

Location

MC Pirogov

Sofia, 1606, Bulgaria

Location

The Military Medical Academy (MHAT)

Sofia, 1606, Bulgaria

Location

Мinistry of Interior - Medical Institute

Sofia, 1606, Bulgaria

Location

University of British Columbia and Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Joseph's Healthcare London

London, Ontario, N6A 4V2, Canada

Location

CHU de Quebec, pavillon Hopital Saint- Sacrement

Québec, G1S 4L8, Canada

Location

Ltd Acad. Fridon Todua Medical Center

Tbilisi, 0112, Georgia

Location

Ltd Israel-Georgian Medical Research Clinic - Helsicore

Tbilisi, 0112, Georgia

Location

JSC Curatio

Tbilisi, 0114, Georgia

Location

Ltd Aversi Clinic

Tbilisi, 0160, Georgia

Location

Ltd Simon Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Jarosław Ślifirski Indywidualna Praktyka Lekarska

Kęty, Lesser Poland Voivodeship, 32-650, Poland

Location

Centrum Medyczne Biotamed

Wieliczka, Lesser Poland Voivodeship, 32-020, Poland

Location

Medicus Sp z o.o.

Wroclaw, Lower Silesian Voivodeship, 50-224, Poland

Location

Mini Clinic Paweł Białogłowski

Łańcut, Podkarpackie Voivodeship, 37-100, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

NZOZ Centrum Medyczne LiMED

Tarnowskie Góry, Silesian Voivodeship, 42-600, Poland

Location

NZOZ Imedica

Poznan, Wielkopolska, 60-537, Poland

Location

ReumaClinic

Bialystok, 15-181, Poland

Location

Przychodnia "Narutowicza"

Inowrocław, 88-100, Poland

Location

Centrum Medyczne All Med - Krakow

Krakow, 30-033, Poland

Location

Medical Center Woś i Piwowarczyk

Krakow, 31-572, Poland

Location

Centrum Alergologii

Lublin, 20-552, Poland

Location

Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie

Strzelce Opolskie, 47-100, Poland

Location

NZOZ "Ignis" dr med. Alicja Łobińska

Świdnik, 21-040, Poland

Location

NZOZ Przychodnia Medycyny Rodzinnej

Świętochłowice, 41-600, Poland

Location

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

Moscow, Moskovskaya Obl., 119435, Russia

Location

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

Moscow, Moskovskaya Obl., 129110, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Smolensk, "Uromed"

Smolensk, Smolenskaya Obl, 214031, Russia

Location

Yaroslavl Regional Clinical Hospital

Yaroslavl, Yaroslavskaya Obl., 150062, Russia

Location

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

Moscow, 121359, Russia

Location

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

Saint Petersburg, 190013, Russia

Location

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

Lund, Skåne County, 222 41, Sweden

Location

Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location

Helsingborg Hospital

Helsingborg, Sverige, 25187, Sweden

Location

ONH Kliniken Sahlgrenska Universitetsynkhiset

Gothenburg, Vastra Gotaland Lan, 413 45, Sweden

Location

Sofiahemmet Hospital

Stockholm, 114 28, Sweden

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Darlington Memorial Hospital

Darlington, DL3 6HX, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

Stockport NHS Foundation Trust (Stepping Hill Hospital Base)

Stockport, SK2 7JE, United Kingdom

Location

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, WN1 2NN, United Kingdom

Location

Results Point of Contact

• Title: John Messina, PharmD, SVP of Clinical Research & Medical Affairs
• Organization: OptiNose

John.Messina@optinose.com

267-521-0565

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: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: November 27, 2018
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: May 29, 2024
• Results First Posted: September 18, 2023

Record last verified: 2024-05

Locations

CA (3); US (46); RU (7); PL (15); BU (6); SE (5); GB (5); GE (5)