Bilateral Nasal PolyposisPhase 3NCT01622569

Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

A Phase 3 study testing Fluticasone Propionate in people with Bilateral Nasal Polyposis, run by Optinose US Inc. at 33 sites in 2 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Bilateral Nasal Polyposis
What is being tested?: Fluticasone Propionate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 323 participants
Where: 33 sitesin 2 countries
Study dates: 19 Nov 2013to 1 Oct 2015
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

Who may be able to join

Men or women aged 18 years and older
Women must
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
be surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation at least 1 year before screening) or otherwise be incapable of pregnancy, or
be postmenopausal (spontaneous amenorrhea for at least 1 year).
Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) or urine pregnancy test (depending on local regulations) at the screening visit

Show all 15Show fewer

Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by the Lildholdt scale score measured by nasoendoscopy at both screening and baseline visits
Must have at least moderate symptoms of nasal congestion/obstruction as reported by the subject for the 7 day period preceding the screening visit
At the baseline visit (Day 1), must have a morning score of at least 2 (moderate) on nasal congestion/obstruction recorded on the subject diary for at least 5 of the last 7 days of the 7 to up to 14 day run-in period
Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
Subjects with comorbid asthma or COPD must be stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral or parenteral steroid use) within the 3 months before the screening visit. 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 screening with plans to continue use throughout the study.
Must be able to cease treatment with intranasal medications including, but not limited to, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for comorbid asthma and COPD) at the screening visit
Must be able to cease treatment with oral and nasal decongestants and antihistamines at the screening visit
Must be able to use the OptiNose device correctly; all subjects will be required to demonstrate correct use of the placebo device at screening, Visit 1.
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.

Who cannot join

Women who are pregnant or lactating
Have complete or near-complete obstruction of the nasal cavities
Inability to achieve bilateral nasal airflow for any reason including nasal septum deviation
Inability to have each nasal cavity examined for any reason including nasal septum deviation
Nasal septum perforation
Has had more than 1 episode of epistaxis with frank bleeding in the month before the screening visit

Show all 30Show fewer

Have evidence of significant baseline mucosal injury, ulceration or erosion (eg, exposed cartilage, perforation) on baseline nasal examination/nasal endoscopy
History of more than 5 sinonasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
History of sinus or nasal surgery within 6 months before the screening visit
History of any surgical procedure that prevents the ability to accurately grade polyps
Have symptoms of seasonal allergic rhinitis at screening or baseline and/or, based on time of year, would anticipate onset of symptoms within 4 weeks of randomization
Current, ongoing rhinitis medicamentosa (rebound rhinitis)
Have significant oral structural abnormalities, eg, a cleft palate
Diagnosis of cystic fibrosis
History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution Note: Subjects who are taking prophylactic antibiotics will be allowed to enter the study as long as they intend to continue the antibiotics for the duration of the study.
Planned sinonasal surgery during the period of the study
Allergy, hypersensitivity, or contraindication to corticosteroids or steroids
Allergy or hypersensitivity to any excipients in study drug
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 the screening visit; except as noted in inclusion criteria for subjects with comorbid asthma or COPD
Have nasal candidiasis
Have taken a potent CYP3A4 inhibitor within 14 days before the screening visit.
History or current diagnosis of any form of glaucoma or ocular hypertension (ie, >21 mmHg)
History of intraocular pressure elevation on any form of steroid therapy
History or current diagnosis of the presence (in either eye) of a cataract
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
A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol use, abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study
Positive urine drug screen at screening visit for drugs of abuse, with the exception of prescribed medications for legitimate medical conditions
Have participated in an investigational drug clinical trial within 30 days of the screening visit
Employees 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, as well as family members of the employees or the investigator

Trial locations and contacts

33 sites in 2 countries.

Country

City, postcode or hospital

33 sites in 2 countries

United States30 sites

Kern Allergy and Medical Research, Inc.
Bakersfield, California, 93301
Clinical Research Group of Montana, PLLC
Bozeman, Montana, 59718
NU Feinberg School of Medicine Depart. of Otolaryngology-Head & Neck Surgery
Chicago, Illinois, 60611
Chicago ENT
Chicago, Illinois, 60657
Cleveland Clinic
Cleveland, Ohio, 44195
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, 80907
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909
Optimed Research
Columbus, Ohio, 43235
AARA Research Center
Dallas, Texas, 75231
Colorado Allergy and Asthma Centers, P.C.
Denver, Colorado, 80230
Central California Clinical Research
Fresno, California, 93720
Ear Nose and Throat Associates of Texas
Frisco, Texas, 43235
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114
California Allergy & Asthma Medical Group, Inc.
Los Angeles, California, 90025
Coastal Ear, Nose and Throat, LLC
Neptune City, New Jersey, 07753
EVMS Depart. Of Otolaryngology
Norfolk, Virginia, 23507
National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
North Charleston, South Carolina, 29420
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, 02747
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Choc PSF, AMC, Division of AA & I
Orange, California, 92868
California Allergy and Asthma Palmdale
Palmdale, California, 93551
ENTTEX
Plano, Texas, 75093
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
California Medical Clinic for Headache
Santa Monica, California, 90404
University of South Florida Asthma, Allergy & Immunology
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10467
SC Clinical Research, Inc.
Tucson, Arizona, 85704
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136

Other trials in United States

Canada3 sites

CHUM Hôtel-Dieu
Montreal, Quebec, H2W 1T8
Dr. Jaime Del Carpio
Montreal, Quebec, H3G 1L5
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1Y 4G2

Other trials in Canada

About this study

Official title: A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of OPN-375 (100, 200, and 400 µg bid) in subjects with bilateral nasal polyposis and nasal congestion.

This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) entered the study.

Pretreatment phase (single-blind, placebo, run-in): 7 to up to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase.
Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2, Day 1 (baseline) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16).
Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 [Week 24]).

Conditions: Bilateral Nasal Polyposis
Being tested: Fluticasone Propionate

What participants receive

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

Fluticasone PropionateDrug
Also called OPN-375
Delivered via Optinose Exhalation Delivery System

Study groups in NCT01622569
Study group	Role	What they receive
OPN-375 100 μg BID	Active comparator	Double-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks Receives: Drug: Fluticasone Propionate
Placebo	Placebo comparator	Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks Receives: Drug: Fluticasone Propionate
OPN-375 200 μg BID	Active comparator	Double-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks Receives: Drug: Fluticasone Propionate
OPN-375 400 μg BID	Active comparator	Double-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks Receives: Drug: Fluticasone Propionate

What is being measured

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

Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase
Measured: Baseline, Week 4 of the double-blind treatment phase
Change in Total Polyp Grade
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade.
0: No polyps
1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline
Measured: Baseline, Week 16 of the double-blind treatment phase

Secondary outcomes (13)

Congestion/Obstruction Scores (7-day Instantaneous Morning)
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase
Measured: Baseline, Week 16 of the double-blind treatment phase
Change in Rhinorrhea Score (7-day Instantaneous Morning)
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase
Measured: Baseline, Week 16 of the double-blind treatment phase
Facial Pain or Pressure Score (7-day Instantaneous Morning)
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase
Measured: Baseline, Week 16 of the double-blind treatment phase
Hyposmia Score (7-day Instantaneous Morning)
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase
Measured: Baseline, Week 16 of the double-blind treatment phase
Sinonasal Outcome Test 22 (SNOT-22) Total Score
SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.
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: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
MOS Sleep-R Score
The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.
Measured: Baseline, Week 16 of the double-blind treatment phase
Rhinosinusitis Disability Index (RSDI) Total Score
The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.
Measured: Baseline, Week 16 of the double-blind treatment phase
SF-36v2 - Mental Component
The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
SF-36v2 - Physical Component
The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Patient Global Impression of Change (PGIC) Score
Subject responses to the question: "Since starting the study drug, how would you rate the change in your symptoms?" Percentage includes patients who scored either "very much improved," "much improved," or "minimally improved."
Measured: Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Peak Nasal Inspiratory Flow (PNIF)
The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase
Polyp Grade of 0 in at Least One Nostril
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril.
0: No polyps
1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Nasal Polyp Surgery Eligilbilty
A subject was considered eligible for surgical intervention if the following conditions were met:
- Subject has had moderate symptoms of congestion from nasal polyposis for ≥ 3 months.
- Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for ≥ 6 weeks.
- Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for ≥ 6 weeks.
- Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score ≥ 2 in at least 1 nostril).
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase

Timeline

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

19 Nov 20131 Oct 2015

First posted19 Jun 2012 (estimated)
Study start19 Nov 2013
Primary completion6 Aug 2015
Study completion1 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bilateral Nasal PolyposisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01622569
Sponsor's protocol ID: OPN-FLU-NP-3101
Status last verified: Nov 2017
First submitted: 13 Jun 2012
Last updated: 26 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ow RA, McGinnis JP 2nd, Sacks HJ, Mehle ME. The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps. Ear Nose Throat J. 2025 Feb;104(2):93-101. doi: 10.1177/01455613221088698. Epub 2022 Apr 18.
PubMed 35437059
Skoner DP, Meltzer EO, Skoner J, Sacks HJ, Lumry WR. Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone. Allergy Asthma Proc. 2022 Jan 9;43(1):70-77. doi: 10.2500/aap.2022.43.210096. Epub 2021 Nov 9.
PubMed 34753535

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
ClinicalTrials.gov ID: NCT01622569
Acronym / sponsor ID: OPN-FLU-NP-3101
Conditions: Bilateral Nasal Polyposis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Optinose US Inc.Industry (pharma, biotech, devices)
Study start: 19 Nov 2013 (actual)
Primary completion: 6 Aug 2015 (actual)
Study completion: 1 Oct 2015 (actual)
First posted: 19 Jun 2012 (estimated)
Results: Posted 5 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) entered the study.

Pretreatment phase (single-blind, placebo, run-in): 7 to up to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase.
Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2, Day 1 (baseline) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16).
Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 [Week 24]).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
OPN-375 100 μg BID	Active comparator	Drug: Fluticasone PropionateDouble-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
Placebo	Placebo comparator	Drug: Fluticasone PropionateDouble-Blind Treatment Phase: Matching Placebo BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
OPN-375 200 μg BID	Active comparator	Drug: Fluticasone PropionateDouble-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
OPN-375 400 μg BID	Active comparator	Drug: Fluticasone PropionateDouble-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Men or women aged 18 years and older
Women must
Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) or urine pregnancy test (depending on local regulations) at the screening visit
Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by the Lildholdt scale score measured by nasoendoscopy at both screening and baseline visits
Must have at least moderate symptoms of nasal congestion/obstruction as reported by the subject for the 7 day period preceding the screening visit

Key exclusion criteria (30 listed)

Women who are pregnant or lactating
Have complete or near-complete obstruction of the nasal cavities
Inability to achieve bilateral nasal airflow for any reason including nasal septum deviation
Inability to have each nasal cavity examined for any reason including nasal septum deviation
Nasal septum perforation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluticasone PropionateAlso: OPN-375Delivered via Optinose Exhalation Delivery System	Drug	OPN-375 100 μg BID, OPN-375 200 μg BID, OPN-375 400 μg BID, Placebo

Primary outcome

Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Time frame: Baseline, Week 4 of the double-blind treatment phase
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase
Change in Total Polyp Grade
Time frame: Baseline, Week 16 of the double-blind treatment phase
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline

13 secondary outcomes

Congestion/Obstruction Scores (7-day Instantaneous Morning)
Time frame: Baseline, Week 16 of the double-blind treatment phase
Change in Rhinorrhea Score (7-day Instantaneous Morning)
Time frame: Baseline, Week 16 of the double-blind treatment phase
Facial Pain or Pressure Score (7-day Instantaneous Morning)
Time frame: Baseline, Week 16 of the double-blind treatment phase
Hyposmia Score (7-day Instantaneous Morning)
Time frame: Baseline, Week 16 of the double-blind treatment phase
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
MOS Sleep-R Score
Time frame: Baseline, Week 16 of the double-blind treatment phase
Rhinosinusitis Disability Index (RSDI) Total Score
Time frame: Baseline, Week 16 of the double-blind treatment phase
SF-36v2 - Mental Component
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
SF-36v2 - Physical Component
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Patient Global Impression of Change (PGIC) Score
Time frame: Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase
Polyp Grade of 0 in at Least One Nostril
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Nasal Polyp Surgery Eligilbilty
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase

Results and safety

Results posted to the registry on 5 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	82	70
100 μg OPN-375	81	75
200 μg OPN-375	80	71
400 μg EDS-FLU	80	76

Primary outcome: Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms

Time frame: Baseline, Week 4 of the double-blind treatment phase. Least squares mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 77	OPN-375 100 μg BID n = 78	OPN-375 200 μg BID n = 79	OPN-375 400 μg BID n = 78
Value	-0.26 (0.08)	-0.53 (0.08)	-0.56 (0.08)	-0.67 (0.08)

Population analysed: Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed.

Primary outcome: Change in Total Polyp Grade

Time frame: Baseline, Week 16 of the double-blind treatment phase. Least squares mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 68	OPN-375 100 μg BID n = 75	OPN-375 200 μg BID n = 68	OPN-375 400 μg BID n = 75
Value	-0.57 (0.14)	-1.04 (0.14)	-1.14 (0.14)	-1.14 (0.14)

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Double-Blind Phase)	0 of 82 (0%)	42 of 82 (51.2%)	0 of 82
OPN-375 100 μg BID (Double-Blind Phase)	1 of 81 (1.2%)	40 of 81 (49.4%)	0 of 81
OPN-375 200 μg BID (Double-Blind Phase)	0 of 80 (0%)	45 of 80 (56.3%)	0 of 80
OPN-375 400 μg BID (Double-Blind Phase)	1 of 79 (1.3%)	50 of 79 (63.3%)	0 of 79
OPN-375 400 μg (Open-Label Phase)	2 of 282 (0.7%)	38 of 282 (13.5%)	0 of 282

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35437059Ow RA, McGinnis JP 2nd, Sacks HJ, Mehle ME. The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps. Ear Nose Throat J. 2025 Feb;104(2):93-101. doi: 10.1177/01455613221088698. Epub 2022 Apr 18.
Derived from this study: PubMed 34753535Skoner DP, Meltzer EO, Skoner J, Sacks HJ, Lumry WR. Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone. Allergy Asthma Proc. 2022 Jan 9;43(1):70-77. doi: 10.2500/aap.2022.43.210096. Epub 2021 Nov 9.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

33 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Propionate in people with Bilateral Nasal Polyposis, run by Optinose US Inc. at 33 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. 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 5 Dec 2018). 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 in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms (time frame: Baseline, Week 4 of the double-blind treatment phase). 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 NCT01622569, 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 26 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.