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

PHASE3CompletedINTERVENTIONAL
Enrollment

332

Participants

Timeline

Start Date

November 27, 2018

Primary Completion Date

January 19, 2022

Study Completion Date

January 19, 2022

Conditions
Chronic Rhinosinusitis
Interventions
DRUG

OPN-375

OPN-375, BID

Trial Locations (92)

1000

MC Iskar, Sofia

1303

Multiprofile Hospital for Active Treatment Serdika, Sofia

1606

MC Pirogov, Sofia

The Military Medical Academy (MHAT), Sofia

Мinistry of Interior - Medical Institute, Sofia

4002

UMHAT - Kaspela EOOD, Plovdiv

10003

Mount Sinai Downtown Union Square, New York

10016

Madison ENT and Facial Plastic Surgery, New York

11042

ENT and Allergy Associates, New Hyde Park

18017

Specialty Physician Associates, Bethlehem

19104

Hospital at the University of PA, Philadelphia

21204

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

21287

John Hopkins Hospital, Baltimore

23507

Eastern Virginia Medical School, Norfolk

25187

Helsingborg Hospital, Helsingborg

28204

Allergy Asthma & Immunology Relief of Charlotte, Charlotte

29420

National Allergy and Asthma Research, North Charleston

29425

Medical University of South Carolina, Charleston

30308

Emory University MOT, Atlanta

37660

Holston Medical Group, Kingsport

40205

Kentuckiana Ear Nose & Throat, Louisville

47150

Advanced ENT and Allergy, New Albany

56303

St. Cloud Ear, Nose & Throat, Saint Cloud

60611

Northwestern Memorial Hospital, Chicago

60612

Rush University Medical Center, Chicago

60637

The University of Chicago, Chicago

61761

Midwest Allergy Sinus Asthma, Normal

65212

University of Missouri, Dept of Otorlaryngology, Columbia

68505

Asthma, Allergy, and Immunology Associates, PC, Lincoln

70121

Ochsner Clinic Foundation, New Orleans

73120

Allergy Asthma & Clinical Research Center, Oklahoma City

74136

Vital Prospects Clinical Research Institute, P.C., Tulsa

77030

University of TX Health Science Ctr at Houston, Houston

78229

STAAMP Research, LLC, San Antonio

80909

Colorado ENT & Allergy, Colorado Springs

84102

Intermountain Ear, Nose & Throat, Salt Lake City

84790

Chrysallis Clinical Research, St. George

85234

AZ Allergy & Immunology Research, Gilbert

90025

Jonathan Corren, MD, Clinical Research Division, Los Angeles

90503

Breathe Clear Institute, Torrance

92647

Allergy & Asthma Specialists Medical Group, Huntington Beach

93301

Kern Research, Bakersfield

94598

Allergy & Asthma Clinical Research, Walnut Creek

95117

Allergy and Asthma Associates of Santa Clara Valley, San Jose

95630

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

95661

Sacramento Ear, Nose & Throat, Roseville

95817

UC Davis Medical Center, Sacramento

97202

Northwest Research Center, Portland

98225

Bellingham Asthma, Allergy & Immunology Clinic, Bellingham

99201

Spokane ENT, Spokane Valley

119435

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

121359

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

129110

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

150062

Yaroslavl Regional Clinical Hospital, Yaroslavl

190013

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

197022

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

214031

"Smolensk, Uromed", Smolensk

06519

Yale School of Medicine Section of Otolaryngology, New Haven

50312-3505

Iowa Head & Neck, Des Moines

07712

Atlantic Research Center, Ocean City

V6Z 1Y6

University of British Columbia and Providence Health Care, Vancouver

N6A 4V2

St. Joseph's Healthcare London, London

G1S 4L8

CHU de Quebec, pavillon Hopital Saint- Sacrement, Québec

0112

Ltd Acad. Fridon Todua Medical Center, Tbilisi

Ltd Israel-Georgian Medical Research Clinic - Helsicore, Tbilisi

0114

JSC Curatio, Tbilisi

0160

Ltd Aversi Clinic, Tbilisi

0179

Ltd Simon Khechinashvili University Hospital, Tbilisi

32-650

Jarosław Ślifirski Indywidualna Praktyka Lekarska, Kęty

32-020

Centrum Medyczne Biotamed, Wieliczka

50-224

Medicus Sp z o.o., Wroclaw

37-100

Mini Clinic Paweł Białogłowski, Łańcut

40-611

Centrum Medyczne Angelius Provita, Katowice

42-600

NZOZ Centrum Medyczne LiMED, Tarnowskie Góry

60-537

NZOZ Imedica, Poznan

15-181

ReumaClinic, Bialystok

88-100

"Przychodnia Narutowicza", Inowrocław

30-033

Centrum Medyczne All Med - Krakow, Krakow

31-572

Medical Center Woś i Piwowarczyk, Krakow

20-552

Centrum Alergologii, Lublin

47-100

Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie, Strzelce Opolskie

21-040

"NZOZ Ignis dr med. Alicja Łobińska", Świdnik

41-600

NZOZ Przychodnia Medycyny Rodzinnej, Świętochłowice

222 41

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

171 76

Karolinska University Hospital, Stockholm

413 45

ONH Kliniken Sahlgrenska Universitetsynkhiset, Gothenburg

114 28

Sofiahemmet Hospital, Stockholm

Unknown

University Hospital of Wales, Cardiff

DL3 6HX

Darlington Memorial Hospital, Darlington

SG1 4AB

Lister Hospital, Stevenage

SK2 7JE

Stockport NHS Foundation Trust (Stepping Hill Hospital Base), Stockport

WN1 2NN

Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan

All Listed Sponsors
lead

Optinose US Inc.

INDUSTRY

NCT03781804 - 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 | Biotech Hunter | Biotech Hunter