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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03960580




Registration number
NCT03960580
Ethics application status
Date submitted
20/05/2019
Date registered
23/05/2019
Date last updated
25/11/2020

Titles & IDs
Public title
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis Without the Presence of Nasal Polyps
Scientific 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 Sinusitis Without the Presence of Nasal Polyps
Secondary ID [1] 0 0
OPN-FLU-CS-3206
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OPN-375

Active Comparator: OPN-375 186 µg BID - OPN-375 186 µg BID x 24 Weeks

Active Comparator: OPN-375 372 µg BID - OPN-375 372 µg BID x 24 Weeks

Placebo Comparator: Placebo - Matching Placebo BID x 24 Weeks


Treatment: Drugs: OPN-375
OPN-375, BID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
4 Weeks
Primary outcome [2] 0 0
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 ranges from -100% to 100%.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score - Change from baseline to Week 24 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22) total score. SNOT-22 is a subject-completed questionnaire that consists of 22 questions. 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. The total score can range from 0-110, 0 being the best and 110 being the worst.
Timepoint [1] 0 0
24 Weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
24 Weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
24 Weeks
Secondary outcome [4] 0 0
Change in frequency of acute exacerbations of chronic sinusitis - Change in frequency of acute exacerbations of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment.
Timepoint [4] 0 0
24 Weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
12 Weeks
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
12 Weeks
Secondary outcome [9] 0 0
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 the ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
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).
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Change from baseline to Week 24/ET in average percent of sinus volume occupied by disease for the maxillary sinus as measured by CT scan assessment
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Change from baseline to Week 24/ET in average percent of sinus volume occupied by disease for the ethmoid sinus as measured by CT scan assessment
Timepoint [12] 0 0
Baseline, Week 24
Secondary outcome [13] 0 0
Change from baseline to week 24/ET in the Zinreich modification of Lund-Mackay Staging System total score - Zinreich 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 40.
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Change from baseline to week 24/ET in the Zinreich modification of Lund-Mackay Staging System for the sinus pairs Change from baseline to week 24/ET in the Zinreich modification of Lund-Mackay Staging System for the sinus pairs - Zeinrich Modification of the Lund-Mackay Staging System:
Zinreich 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%
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
24 Weeks]
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
8 Weeks
Secondary outcome [17] 0 0
Change from baseline to defined timepoints - 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. 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.
Timepoint [17] 0 0
24 Weeks
Secondary outcome [18] 0 0
Change in baseline to Week 24/ET as measured by the Euroqol 5-dimension (EQ-5D) instrument - The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The subject is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the subject's health state. Scores for health state range from 0 to 1. The EQ VAS 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 reflect the subject's own judgement. VAS scores range from 0 to 100.
Timepoint [18] 0 0
24 Weeks
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
24 Weeks
Secondary outcome [20] 0 0
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 0.291 to 1
Timepoint [20] 0 0
24 Weeks
Secondary outcome [21] 0 0
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.
Timepoint [21] 0 0
24 Weeks
Secondary outcome [22] 0 0
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.
Timepoint [22] 0 0
24 Weeks
Secondary outcome [23] 0 0
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 accompany each test item. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposomia) as well as an index to detect malingering.
Timepoint [23] 0 0
24 Weeks
Secondary outcome [24] 0 0
Change in overall health from baseline to Week 24/ET as measured by the percent of subjects improved as indicated by the Patient Global Impression of Change (PGIC) at Week 24/ET - 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
Timepoint [24] 0 0
Week 4, Week 24
Secondary outcome [25] 0 0
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. - Presenteeism can be converted to number of days of productive time lost per month, and when added to the number of lost days due to absenteeism provides an estimate of total productive work days lost.
Timepoint [25] 0 0
24 Weeks

Eligibility
Key inclusion criteria
1. men or women aged 18 years and older at baseline visit

2. women of child bearing 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 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

5. endoscopic evidence of nasal mucosal disease, with edema or purulent discharge; or
polyps/polypoid tissue <Grade 1 in middle meatus, bilaterally

6. 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)

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 oral steroids, intranasal steroids, inhaled
corticosteroids (except permitted doses listed above for asthma and COPD) at the
baseline 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 correctly; all subjects will be
required to demonstrate correct use with the practice exhalation delivery system (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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 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 polyp grade =1 (polyp that is free on 5 sides and has a stalk) on either side of
the nose 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 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 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 chronic sinusitis 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, intraarticular, 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
(intraocular pressure at screening of >21 mm Hg)

27. history of intraocular pressure elevation on any form of steroid therapy

28. history or current diagnosis of the presence (in either eye) of a subcapsular cataract

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) inhibitors (eg, ritonavir, atazanavir,
clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir,
ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole)

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Camberwell Road Medical Practice - Hawthorn East
Recruitment hospital [3] 0 0
TrialsWest Pty Ltd - Murdoch
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
3016 - Hawthorn East
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Czechia
State/province [14] 0 0
Benesov
Country [15] 0 0
Czechia
State/province [15] 0 0
Olomouc
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague
Country [17] 0 0
New Zealand
State/province [17] 0 0
Bay Of Plenty
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Hamilton
Country [20] 0 0
New Zealand
State/province [20] 0 0
Wellington
Country [21] 0 0
Poland
State/province [21] 0 0
Kujawsko-Pomorskie
Country [22] 0 0
Poland
State/province [22] 0 0
Malopolskie
Country [23] 0 0
Poland
State/province [23] 0 0
Bialystok
Country [24] 0 0
Poland
State/province [24] 0 0
Gdynia
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Kety
Country [27] 0 0
Poland
State/province [27] 0 0
Lancut
Country [28] 0 0
Poland
State/province [28] 0 0
Strzelce Opolskie
Country [29] 0 0
Poland
State/province [29] 0 0
Tarnowskie Góry
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Poland
State/province [31] 0 0
Wroclaw
Country [32] 0 0
Poland
State/province [32] 0 0
Swietochlowice
Country [33] 0 0
Romania
State/province [33] 0 0
Brasov
Country [34] 0 0
Romania
State/province [34] 0 0
Bucuresti
Country [35] 0 0
Romania
State/province [35] 0 0
Cluj-Napoca
Country [36] 0 0
Romania
State/province [36] 0 0
Iasi
Country [37] 0 0
Spain
State/province [37] 0 0
A Coruna
Country [38] 0 0
Spain
State/province [38] 0 0
Cadiz
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Seville
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Nottinghamshire
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Great Yarmouth
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Optinose US Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 sinusitis (CS) without nasal polyps
Trial website
https://clinicaltrials.gov/show/NCT03960580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Carothers
Address 0 0
Optinose US Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susan Torchio
Address 0 0
Country 0 0
Phone 0 0
267-521-0717
Fax 0 0
Email 0 0
susan.torchio@optinose.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03960580