Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis
Lead sponsor: Optinose US Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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,

   1. 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
   2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
   3. be postmenopausal (amenorrhea for at least 1 year)
3. women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Screening)
4. 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
5. 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
6. 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)
7. baseline CT scan must show a combined ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus
8. 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
9. 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
10. must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
11. 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.
12. 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.
13. must be able to cease treatment with intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit
14. must be able to cease treatment with oral and nasal decongestants and antihistamines at Visit 1 (Screening)
15. 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).
16. 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

Primary outcomes:
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
timeFrame: 4 Weeks
measure: Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: 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
timeFrame: Week 24
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)
timeFrame: Week 12
measure: Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores
timeFrame: 12 Weeks
measure: Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores
timeFrame: 12 Weeks
measure: Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores
timeFrame: 12 Weeks
measure: Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores
timeFrame: 12 Weeks
measure: 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
timeFrame: 24 Weeks
measure: Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined
timeFrame: 24 Weeks
measure: Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
timeFrame: Week 24
measure: 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
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Baseline, Week 24
measure: 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
timeFrame: 24 Weeks
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined
timeFrame: Baseline, Week 24
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Baseline, Week 24
measure: Time Comparison to First Acute Exacerbation of Chronic Sinusitis
timeFrame: 24 Weeks
measure: Percentage of Subjects Requiring Rescue Medication After Week 4
timeFrame: 8 Weeks
measure: Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 Weeks, 24 Weeks
measure: 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)
timeFrame: Week 4, Week 24
measure: Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
timeFrame: Week 24
measure: Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)
timeFrame: 24 Weeks
measure: Change in the SF-36v2 Physical Composite Score (PCS)
timeFrame: 24 Weeks
measure: Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
timeFrame: 24 Weeks
measure: 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)
timeFrame: 24 Weeks
measure: Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™
timeFrame: 24 Weeks
measure: Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)
timeFrame: 24 Weeks
measure: Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument
timeFrame: 24 Weeks
measure: Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery
timeFrame: Baseline, Week 24
measure: Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention
timeFrame: Baseline, Week 24
measure: Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery
timeFrame: Week 24
measure: Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).
timeFrame: 24 Weeks
Other outcomes:
measure: Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
timeFrame: 24 Weeks
measure: Evaluation of Safety-Nasal Examination
timeFrame: 24 Weeks
measure: Evaluation of Safety Measuring Vital Signs- Blood Pressure
timeFrame: 24 Weeks
measure: Evaluation of Safety Measuring Vital Signs- Pulse
timeFrame: 24 Weeks
measure: Evaluation of Safety Measuring Vital Signs- Weight
timeFrame: 24 Weeks
measure: Evaluation of Safety - Monitoring Concomitant Medication Usage
timeFrame: 24 Weeks
Locations:
city: Gilbert
country: United States
facility: AZ Allergy & Immunology Research
state: Arizona
city: Bakersfield
country: United States
facility: Kern Research
state: California
city: Folsom
country: United States
facility: Sacramento Ear, Nose & Throat Surgical and Medical Group Inc
state: California
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialists Medical Group
state: California
city: Los Angeles
country: United States
facility: Jonathan Corren, MD, Clinical Research Division
state: California
city: Roseville
country: United States
facility: Sacramento Ear, Nose & Throat
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine Section of Otolaryngology
state: Connecticut
city: Atlanta
country: United States
facility: Emory University MOT
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma
state: Illinois
city: New Albany
country: United States
facility: Advanced ENT and Allergy
state: Indiana
city: Des Moines
country: United States
facility: Iowa Head & Neck
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Ear Nose & Throat
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Towson
country: United States
facility: Ear, Nose and Throat Associates at Greater Baltimore Medical Center
state: Maryland
city: Saint Cloud
country: United States
facility: St. Cloud Ear, Nose & Throat
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri, Dept of Otorlaryngology
state: Missouri
city: Lincoln
country: United States
facility: Asthma, Allergy, and Immunology Associates, PC
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center
state: New Jersey
city: New Hyde Park
country: United States
facility: ENT and Allergy Associates
state: New York
city: New York
country: United States
facility: Mount Sinai Downtown Union Square
state: New York
city: New York
country: United States
facility: Madison ENT and Facial Plastic Surgery
state: New York
city: Charlotte
country: United States
facility: Allergy Asthma & Immunology Relief of Charlotte
state: North Carolina
city: Oklahoma City
country: United States
facility: Allergy Asthma & Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital at the University of PA
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: North Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Houston
country: United States
facility: University of TX Health Science Ctr at Houston
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysallis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Ear, Nose & Throat
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy & Immunology Clinic
state: Washington
city: Spokane Valley
country: United States
facility: Spokane ENT
state: Washington
city: Plovdiv
country: Bulgaria
facility: UMHAT - Kaspela EOOD
city: Sofia
country: Bulgaria
facility: MC Iskar
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika
city: Sofia
country: Bulgaria
facility: MC Pirogov
city: Sofia
country: Bulgaria
facility: The Military Medical Academy (MHAT)
city: Sofia
country: Bulgaria
facility: Мinistry of Interior - Medical Institute
city: Vancouver
country: Canada
facility: University of British Columbia and Providence Health Care
state: British Columbia
city: London
country: Canada
facility: St. Joseph's Healthcare London
state: Ontario
city: Québec
country: Canada
facility: CHU de Quebec, pavillon Hopital Saint- Sacrement
city: Tbilisi
country: Georgia
facility: Ltd Acad. Fridon Todua Medical Center
city: Tbilisi
country: Georgia
facility: Ltd Israel-Georgian Medical Research Clinic - Helsicore
city: Tbilisi
country: Georgia
facility: JSC Curatio
city: Tbilisi
country: Georgia
facility: Ltd Aversi Clinic
city: Tbilisi
country: Georgia
facility: Ltd Simon Khechinashvili University Hospital
city: Wrocław
country: Poland
facility: Medicus Sp z o.o.
state: Dolnoslaskie
city: Wieliczka
country: Poland
facility: Centrum Medyczne Biotamed
state: Malopolskie
city: Kęty
country: Poland
facility: Jarosław Ślifirski Indywidualna Praktyka Lekarska
state: MA
city: Łańcut
country: Poland
facility: Mini Clinic Paweł Białogłowski
state: PK
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: SL
city: Tarnowskie Góry
country: Poland
facility: NZOZ Centrum Medyczne LiMED
state: SL
city: Poznań
country: Poland
facility: NZOZ Imedica
state: Wielkopolska
city: Białystok
country: Poland
facility: ReumaClinic
city: Inowrocław
country: Poland
facility: Przychodnia "Narutowicza"
city: Kraków
country: Poland
facility: Centrum Medyczne All Med - Krakow
city: Kraków
country: Poland
facility: Medical Center Woś i Piwowarczyk
city: Lublin
country: Poland
facility: Centrum Alergologii
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie
city: Świdnik
country: Poland
facility: NZOZ "Ignis" dr med. Alicja Łobińska
city: Świętochłowice
country: Poland
facility: NZOZ Przychodnia Medycyny Rodzinnej
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University-University Hospital No.1 - Ear, Nose, and Throat Clinic
state: Moskovskaya Obl.
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific Research Clinical Institute n.a. M.F. Vladimirsky (MONIKI)
state: Moskovskaya Obl.
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University n.a. I.P. Pavlov
state: Saint-Petersburg
city: Smolensk
country: Russian Federation
facility: Smolensk, "Uromed"
state: Smolenskaya Obl
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
state: Yaroslavskaya Obl.
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic" Office of Affairs of the President of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Institute of Ear, Nose, Throat, and Speech (The RSFSR Ministry of Health)
city: Lund
country: Sweden
facility: ONH Klinikun Skane Universitetssjukhuset (Lund - Oron- Nas- Och Halskliniken)
state: Skane Lan
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Stockholms Lan
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Sverige
city: Gothenburg
country: Sweden
facility: ONH Kliniken Sahlgrenska Universitetsynkhiset
state: Vastra Gotaland Lan
city: Stockholm
country: Sweden
facility: Sofiahemmet Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Cf14 4xw
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust (Stepping Hill Hospital Base)
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh NHS Foundation Trust
Study officials:
affiliation: Optinose US Inc.
name: Jennifer Carothers
role: STUDY_DIRECTOR
affiliation: Optinose US Inc.
name: John Messina
role: STUDY_CHAIR
References: