Bilateral Nasal PolyposisPhase 3NCT03747458
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
A Phase 3 study testing OPN-375 in people with Bilateral Nasal Polyposis, run by Optinose US Inc. at 31 sites in 2 countries.
Trial summary
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Bilateral Nasal Polyposis
- What is being tested?
- OPN-375
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 31 Dec 2018to 11 Jun 2026
- Phase
- Phase 3
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening).
- Female subjects, if sexually active, must,
- be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., 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, tubal ligation, or otherwise be incapable of pregnancy), or
- be abstinent.
- All female subjects not documented to be infertile (e.g., infertility due to congenital abnormality or surgical sterilization) must have a negative serum or urine beta-human chorionic gonadotropin (hCG) at Visit 1 (Screening) and a negative urine pregnancy test at the Visit 2 (Day 1/Randomization/Baseline).
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- Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Screening).
- Must report at least mild symptoms of nasal congestion/obstruction as demonstrated by an average morning nasal congestion/obstruction score of at least 1.0 over a 7 day period during the single-blind run-in period. (Subjects not meeting this inclusion criterion may be re-screened once after at least 4 weeks.)
- Subjects with comorbid asthma must be stable, defined as no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before Visit 1 (Screening). Subjects who received inhaled corticosteroids are required to be on no more than a moderate dosage regimen as defined by 2015 Global Initiative for Asthma Guidelines (GINA) for 1 month before Visit 1 (Screening) and to be expected to remain on it throughout the study (GINA 2015). Subjects receiving inhaled fluticasone alone or in combination may not participate in the PK sub-study.
- Must be able to cease treatment with intranasal medications including, but not limited to, intranasal oxymetazoline or any other decongestants, intranasal antihistamines, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for asthma) at Visit 1 (Screening). [Note: intranasal antibiotics and saline are permissible]
- If taking oral antihistamines, must be on a stable regimen for at least 2 weeks prior to Visit 1 (Screening), and agree to not change the dose of these medications until after Visit 3 (Week 4) of the study.
- Subjects (with assistance from parent or legal guardian if needed) must demonstrate the ability to complete the daily diary during the run-in period to be eligible for randomization.
- Must demonstrate correct use of the demo EDS.
- Must be capable, in the opinion of the investigator, of providing assent and the appropriate parent(s) or guardian must provide an informed consent to participate in the study.
Who cannot join
- Pregnancy or lactation
- Has a history of cystic fibrosis
- Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months
- Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation
- Inability to examine both nasal cavities for any reason, including severe nasal septum deviation
- Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy
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- Other significant nasal pathology or abnormal anatomy
- Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening)
- History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
- Have had any surgery on the nasal septum
- History of sinus or nasal surgery within 6 months before Visit 1 (Screening)
- History of any surgical procedure that prevents the ability to accurately diagnose or grade polyps
- Current, ongoing rhinitis medicamentosa (rebound rhinitis)
- Have significant oral structural abnormalities (e.g., a cleft palate)
- History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
- Purulent nasal infection (recent fever or symptoms of lethargy), acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Screening). Potential subjects presenting with one of these infections may be rescreened after 4 weeks.
- Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids
- Have a hypersensitivity to any excipients in the study drug
- Exposure to any glucocorticoid treatment with potential for systemic effects (e.g., oral or parenteral steroids, high dose topical steroids) within 1 month before Visit 1 (Screening); except as noted in inclusion criteria for subjects with comorbid asthma
- Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1
- Have nasal or oral candidiasis
- Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening)
- Any serious or unstable concurrent disease, psychiatric disorder, or any significant concomitant medical 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, or pose a specific risk to the subject due to study participation
- History or current diagnosis of any form of glaucoma or ocular hypertension (i.e., >21 mm Hg)
- History of intraocular pressure elevation on any form of steroid therapy
- Current diagnosis of the presence (in either eye) of a cataract of Grade 1 or greater as defined on the Eye Examination Worksheet OR, less than a Grade 1 cataract with associated visual impairment
- A recent (within 1 year of Visit 1 [Screening]) history of drug or alcohol abuse or dependence
- Positive urine drug screen at screening visit for stimulants, opioids, or cocaine
- Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening)
- Parents, guardian or caregivers of the subject who are 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
31 sites in 2 countries.
31 sites in 2 countries
United States22 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Kern Research
Bakersfield, California, 93301
Allergy Asthma & Immunology Research Institute
Charlotte, North Carolina, 28204
Chicago ENT
Chicago, Illinois, 60657
Central California Clinical Research
Fresno, California, 93720
San Tan Allergy & Asthma
Gilbert, Arizona, 85234
Sensa Health
Los Angeles, California, 90006
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Kentuckiana ENT
Louisville, Kentucky, 40205
Eastern Virginia Medical School - Otolaryngology
Norfolk, Virginia, 23507
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Children's Hospital of Orange County
Orange, California, 92868
Carolina ENT
Orangeburg, South Carolina, 29118
Allergy and Asthma Consultants
Redwood City, California, 94063
University of Rochester
Rochester, New York, 14642
Sacramento ENT
Roseville, California, 95661
University of Utah
Salt Lake City, Utah, 84132
STAAMP Research
San Antonio, Texas, 78229
Rady Children's Hospital San Diego
San Diego, California, 92123
Spokane ENT
Spokane Valley, Washington, 99216
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Argentina9 sites
Sanatorio Guemes
Buenos Aires, C1180AAX
Fundacion CIDEA
Buenos Aires, C1411ABE
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
Buenos Aires, C1425BEN
Instituto de Asma Alergia y Enfermedades Respiratoria (IAAER)
Corrientes, W3400AVV
Centro Medico INSARES
Mendoza, M5500CCG
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, X5008AEV
Instituto Medico de la Fundacion de Estudios Clinicos - Consultorios Integrados Rosario
Rosario, Santa Fe Province, S2000DEJ
Centro de Investigaciones Clinicas - Instituto de la Salud Rosario
Rosario, Santa Fe Province, S200DBS
Clinica Mayo, UMCB
San Miguel de Tucumán, Tucumán Province, T4000IHE
About this study
Official title: 16-Week Randomized Double-Blind Placebo Controlled Parallel-Group Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day in Adolescents With Bilateral Nasal Polyps Followed With 12-Week Open-Label Treatment Phase
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 72 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.
Read the detailed description
The primary objective of this study is to evaluate the efficacy of intranasal administration of OPN-375 186 μg Twice a Day (BID) versus placebo in adolescents with bilateral nasal polyposis and nasal congestion by analyzing the reduction of nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning diary symptom scores and the reduction in total polyp grade at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale.
- Conditions
- Bilateral Nasal Polyposis
- Being tested
- OPN-375
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPN-375Drug
OPN-375, BID
| Study group | Role | What they receive |
|---|---|---|
| OPN-375 186 μg BID | Active comparator | Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks
Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks Receives: Drug: OPN-375 |
| Placebo | Placebo comparator | Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks Receives: Drug: OPN-375 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal congestion/obstruction symptoms (mild, moderate, severe) at the end of Week 4
Change in nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA). The nasal symptom scale is what is used to score the nasal congestion/obstruction score, which is recorded in the diary. Nasal symptom scale is graded on a scale of 0=no symptom, 1=mild symptom, 2=moderate symptom, 3=severe symptom.
Measured: 4 Weeks
Mean change from baseline at Week 16 in total polyp grade
Change in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
Measured: 16 Weeks
Secondary outcomes (11)
Change in bilateral polyp grade over time
nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
Measured: 16 Weeks
Percentage of subjects with a ≥1 point improvement in polyp grade
nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
Measured: 16 Weeks
Percentage of subject with a grade of 0 on at least one side of the nose
nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril
Measured: 16 Weeks
Change in diary symptom scores for the symptoms of nasal congestion/obstruction, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)
The Nasal Symptom Scale is graded on a scale of 0 (no symptom) to 3 (Severe symptom)
Measured: 16 Weeks
Change in diary symptom scores for the symptoms of rhinorrhea, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)
The Nasal Symptom Scale is graded on a scale of 0 (no symptom) to 3 (Severe symptom)
Measured: 16 Weeks
Change in diary symptom scores for the symptoms of facial pain or pressure, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)
The Nasal Symptom Scale is graded on a scale of 0 (no symptom) to 3 (Severe symptom)
Measured: 16 Weeks
Change in diary symptom scores for the sense of smell, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)
Sense of smell will be scored on a scale from 0 (normal) to 3 (absent, no sense of smell)
Measured: 16 Weeks
The proportions of subjects who have reductions in the AM and PM, instantaneous and reflective, average nasal congestion/obstruction symptom scores by 0.5 or more points from baseline to the end of the double-blind treatment phase
The Nasal Symptom Scale is graded on a scale of 0 (no symptom) to 3 (Severe symptom)
Measured: 16 Weeks
Subjects will assess their global impression of change since starting the study drug using the PGIC scale
Subject global impression of change will be assessed using a subject-completed PGIC scale, with a single question rated from 1=very much improved to 7=very much worse
Measured: 16 Weeks
Subjects will assess their change in quality of life since starting the study drug using the quality of life questionnaire (SN-5).
Quality of life assessment using the SN-5 Questionnaire, a subject/parent-completed questionnaire that consists of 5 specific symptoms-related questions (answered on a 7-point Likert scale on the frequency of symptoms, 1=none of the time, 7=all of the time), and 1 general overall quality of life question (answered on a visual analog scale from 0 to 10, worst to best).
Measured: 16 Weeks
Proportion of subjects eligible for surgical intervention (independent of actual surgery performed)
The assessment criteria are as follows:
- Subject has had moderate symptoms of congestion from nasal polyposis for at least 3 months.
- Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for at least 6 weeks.
- Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for at least 6 weeks.
- Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score > 2 in at least 1 nostril). Also assess each subject's eligibility for surgery based on specific of criteria (see Section 12) independent of whether the subject actually undergoes surgery.
Measured: Visit 1 (Screening) and Visit 6 (Week 16/ End of Double-Blind/Early Termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start31 Dec 2018
- Primary completion31 Mar 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optinose US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paratek Pharmaceuticals Inc
- Responsible party
- Sponsor
- Investigators
- Amy Manley, Study chair, Paratek Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747458
- Sponsor's protocol ID
- OPN-FLU-NP-3103
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No