RECRUITING

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2018-12-31

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03747458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening). 2. Female subjects, if sexually active, must, 1. 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 2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or 3. be abstinent. 3. 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). 4. 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). 5. 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.) 6. 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. 7. 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). \[Note: intranasal antibiotics and saline are permissible\] 8. 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. 9. 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. 10. Must demonstrate correct use of the demo EDS. 11. 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.	1. Pregnancy or lactation 2. Has a history of cystic fibrosis 3. Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months 4. Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation 5. Inability to examine both nasal cavities for any reason, including severe nasal septum deviation 6. Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy 7. Other significant nasal pathology or abnormal anatomy 8. Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening) 9. History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime) 10. Have had any surgery on the nasal septum 11. History of sinus or nasal surgery within 6 months before Visit 1 (Screening) 12. History of any surgical procedure that prevents the ability to accurately diagnose or grade polyps 13. Current, ongoing rhinitis medicamentosa (rebound rhinitis) 14. Have significant oral structural abnormalities (e.g., a cleft palate) 15. History of Churg-Strauss syndrome or dyskinetic ciliary syndromes 16. 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. 17. Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids 18. Have a hypersensitivity to any excipients in the study drug 19. 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 20. Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1 21. Have nasal or oral candidiasis 22. Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening) 23. 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 24. History or current diagnosis of any form of glaucoma or ocular hypertension (i.e., \>21 mm Hg) 25. History of intraocular pressure elevation on any form of steroid therapy 26. 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 27. A recent (within 1 year of Visit 1 \[Screening\]) history of drug or alcohol abuse or dependence 28. Positive urine drug screen at screening visit for stimulants, opioids, or cocaine 29. Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening) 30. 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.

Inclusion Criteria

Exclusion Criteria

1. Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening).
2. Female subjects, if sexually active, must,
1. 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
2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
3. be abstinent.
3. 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).
4. 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).
5. 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.)
6. 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.
7. 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). \[Note: intranasal antibiotics and saline are permissible\]
8. 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.
9. 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.
10. Must demonstrate correct use of the demo EDS.
11. 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.

1. Pregnancy or lactation
2. Has a history of cystic fibrosis
3. Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months
4. Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation
5. Inability to examine both nasal cavities for any reason, including severe nasal septum deviation
6. Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy
7. Other significant nasal pathology or abnormal anatomy
8. Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening)
9. History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
10. Have had any surgery on the nasal septum
11. History of sinus or nasal surgery within 6 months before Visit 1 (Screening)
12. History of any surgical procedure that prevents the ability to accurately diagnose or grade polyps
13. Current, ongoing rhinitis medicamentosa (rebound rhinitis)
14. Have significant oral structural abnormalities (e.g., a cleft palate)
15. History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
16. 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.
17. Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids
18. Have a hypersensitivity to any excipients in the study drug
19. 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
20. Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1
21. Have nasal or oral candidiasis
22. Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening)
23. 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
24. History or current diagnosis of any form of glaucoma or ocular hypertension (i.e., \>21 mm Hg)
25. History of intraocular pressure elevation on any form of steroid therapy
26. 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
27. A recent (within 1 year of Visit 1 \[Screening\]) history of drug or alcohol abuse or dependence
28. Positive urine drug screen at screening visit for stimulants, opioids, or cocaine
29. Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening)
30. 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.

Contacts and Locations

Study Contact

Alissa Sirbu

CONTACT

484-751-4926

alissa.sirbu@paratekpharma.com

Amy Manley

CONTACT

amy.manley@paratekpharma.com

Principal Investigator

Amy Manley

STUDY_CHAIR

Paratek Pharma

Study Locations (Sites)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209

United States

San Tan Allergy & Asthma

Gilbert, Arizona, 85234

United States

Kern Research

Bakersfield, California, 93301

United States

Central California Clinical Research

Fresno, California, 93720

United States

Sensa Health

Los Angeles, California, 90006

United States

Children's Hospital of Los Angeles

Los Angeles, California, 90027

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Allergy and Asthma Consultants

Redwood City, California, 94063

United States

Sacramento ENT

Roseville, California, 95661

United States

Rady Children's Hospital San Diego

San Diego, California, 92123

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Yale School of Medicine, Section of Otolaryngology

New Haven, Connecticut, 06519

United States

Nemours Children's Specialty Care

Jacksonville, Florida, 32207

United States

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

United States

Rush University Medical Center - Department of Otorhinolaryngology

Chicago, Illinois, 60612

United States

Chicago ENT

Chicago, Illinois, 60657

United States

Kentuckiana ENT

Louisville, Kentucky, 40205

United States

Ochsner Medical Center, Otorhinolaryngology Department

New Orleans, Louisiana, 70121

United States

Children's Minnesota

Minneapolis, Minnesota, 55102

United States

University of Missouri Medical Center

Columbia, Missouri, 65212

United States

University of Rochester

Rochester, New York, 14642

United States

Allergy Asthma & Immunology Research Institute

Charlotte, North Carolina, 28204

United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120

United States

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136

United States

MUSC Department of Otolaryngology, Head and Neck Surgery

Charleston, South Carolina, 29425

United States

Carolina ENT

Orangeburg, South Carolina, 29118

United States

STAAMP Research

San Antonio, Texas, 78229

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Eastern Virginia Medical School - Otolaryngology

Norfold, Virginia, 23507

United States

Spokane ENT

Spokane Valley, Washington, 99216

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Optinose US Inc.

Amy Manley, STUDY_CHAIR, Paratek Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-31

Study Completion Date2026-03

Study Record Updates

Study Start Date2018-12-31

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Bilateral Nasal Polyposis