Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Эффективность и безопасность 186 мкг носового спрея OPN-375 два раза в день (BID) у подростков с хроническим ринозинуситом без полипов носа. (Re-Open 3)

15 сентября 2026 г. обновлено: Optinose US Inc.

12-недельное рандомизированное, двойное слепое плацебо-контролируемое, многоцентровое исследование, оценивающее эффективность и безопасность интраназального введения 186 мкг OPN-375 два раза в день (BID) у подростков с хроническим ринозинуситом без полипов с носовым

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

The primary objective of this study is to compare the efficacy of intranasal administration of OPN-375 (fluticasone propionate)186 µg twice a day (BID) versus placebo in adolescents with chronic rhinosinusitis (CRS) without nasal polyps (sNP) using the endpoint of change from baseline in CRS symptoms as measured by a 7-day average instantaneous composite score of nasal symptoms (CSS) at the end of Week 4. The CSS is the sum of scores assigned to the symptoms congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior), on a scale of 0 (non-symptomatic) to 3 (severe symptoms). The total CSS can range from 0-9. Eligible study subjects will complete a 7 to 21 day screening period followed by a 12-week double-blind treatment period, for a total of approximately 15 weeks of participation. The study consists of 3 on-site study visits (screening/V1, randomization/V2, end of study/V3/Week 12) and two telephone calls at participation weeks 4 and 8.

The study will include a pharmacokinetic (PK) substudy in which PK assessment of 186 µg OPN-375 in up to 14 study subjects will be conducted in an open label fashion.

Тип исследования

Интервенционный

Регистрация (Оцененный)

84

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Соединенные Штаты
    • Alabama
      • Huntsville, Alabama, Соединенные Штаты, 35801
        • Еще не набирают
        • North Alabama ENT
        • Контакт:
        • Главный следователь:
          • Jasper Castillo, MD
    • Arizona
      • Gilbert, Arizona, Соединенные Штаты, 85214
        • Отозван
        • San Tan Allergy & Asthma
    • California
      • Los Angeles, California, Соединенные Штаты, 90027
        • Еще не набирают
        • Childrens Hospital of Los Angeles
        • Контакт:
          • Beth (Osterbauer) Giannascoli
          • Номер телефона: 323-361-3539
          • Электронная почта: bosterbauer@chla.usc.edu
        • Главный следователь:
          • Elisabeth Ference, MD
      • Orange, California, Соединенные Штаты, 92868
        • Рекрутинг
        • Children's Hospital of Orange County
        • Контакт:
          • Jenny Vo
          • Номер телефона: 714-509-4254
          • Электронная почта: jenny.vo@choc.org
        • Главный следователь:
          • Jay Bhatt, MD
      • Sacramento, California, Соединенные Штаты, 95661
        • Рекрутинг
        • DaVinci Research, LLC
        • Контакт:
        • Главный следователь:
          • Randall Ow, MD
      • San Diego, California, Соединенные Штаты, 92123
        • Еще не набирают
        • Rady Childrens Hospital San Diego
        • Главный следователь:
          • Vijay Patel, MD
        • Контакт:
          • Sasha Shenk
          • Номер телефона: 224190 858-966-1700
          • Электронная почта: sshenk@rchsd.org
      • Torrance, California, Соединенные Штаты, 90503
        • Рекрутинг
        • Breathe Clear Institute
        • Главный следователь:
          • Steven Davis, MD
        • Контакт:
    • Colorado
      • Aurora, Colorado, Соединенные Штаты, 80045
        • Рекрутинг
        • Children's Hospital Colorado
        • Главный следователь:
          • Sarah Gitomer, MD
        • Контакт:
      • Colorado Springs, Colorado, Соединенные Штаты, 80909
        • Рекрутинг
        • Colorado ENT & Allergy
        • Контакт:
          • Monica Davis
          • Номер телефона: 719-867-7804
          • Электронная почта: mdavis@coloradoent.com
        • Главный следователь:
          • Bryan Davis, MD
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30329
        • Еще не набирают
        • Children's Healthcare of Atlanta
        • Контакт:
        • Главный следователь:
          • Lori Gentile, MD
    • Illinois
      • Springfield, Illinois, Соединенные Штаты, 62702
        • Рекрутинг
        • Southern Illinois University School of Medicine
        • Контакт:
          • Alaine Nixon
          • Номер телефона: 217-545-8065
          • Электронная почта: anixon45@siumed.edu
        • Главный следователь:
          • Dana Crosby, MD
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40205
        • Рекрутинг
        • Kentuckiana ENT
        • Главный следователь:
          • Thomas Higgins, MD
        • Контакт:
    • Maryland
      • Towson, Maryland, Соединенные Штаты, 21204
        • Рекрутинг
        • Centers for Advanced ENT Care
        • Контакт:
          • Holly Stadden
          • Номер телефона: 410-821-5151
          • Электронная почта: hstadden@cadentcare.com
        • Главный следователь:
          • Douglas Reh, MD
    • Missouri
      • Columbia, Missouri, Соединенные Штаты, 65212
        • Рекрутинг
        • University of Missouri Medical Center
        • Контакт:
        • Главный следователь:
          • Christine Franzese, MD
    • New York
      • Rochester, New York, Соединенные Штаты, 14642
        • Рекрутинг
        • University of Rochester Medical Center
        • Контакт:
        • Главный следователь:
          • Li-Xing Man, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73120
        • Рекрутинг
        • Allergy, Asthma and Clinical Research Center
        • Главный следователь:
          • Martha Tarpay, MD
        • Контакт:
          • Nasir Ali, MD
          • Номер телефона: 405-286-9431
          • Электронная почта: ali@mtarpay.com
      • Tulsa, Oklahoma, Соединенные Штаты, 74136
        • Рекрутинг
        • Vital Prospects Clinical Research Institute
        • Главный следователь:
          • Iftikhar Hussain, MD
        • Контакт:
    • South Carolina
      • North Charleston, South Carolina, Соединенные Штаты, 29414
        • Рекрутинг
        • Charleston ENT & Allergy
        • Главный следователь:
          • Thomas Murphy, MD
        • Контакт:
      • Orangeburg, South Carolina, Соединенные Штаты, 29118
        • Рекрутинг
        • Carolina ENT Clinic/CENTRI Inc.
        • Контакт:
          • Simone Ansley
          • Номер телефона: 803-536-5511
          • Электронная почта: sansley700@gmail.com
        • Главный следователь:
          • John Ansley, MD
    • Texas
      • Austin, Texas, Соединенные Штаты, 78759
        • Рекрутинг
        • Orion Clinical Research
        • Контакт:
        • Главный следователь:
          • William Howland, III, MD
      • San Antonio, Texas, Соединенные Штаты, 78229
        • Рекрутинг
        • STAAMP Research
        • Главный следователь:
          • Erika Gonzalez, MD
        • Контакт:
      • San Antonio, Texas, Соединенные Штаты, 78258
        • Рекрутинг
        • Alamo ENT Associates
        • Контакт:
          • Maxine Mata
          • Номер телефона: 210-545-0404
          • Электронная почта: m.mata@alamoent.com
        • Главный следователь:
          • Jeffrey Rosenbloom, MD
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84112
        • Рекрутинг
        • University of Utah
        • Главный следователь:
          • Jill Jeffe, MD
        • Контакт:
    • Virginia
      • Norfolk, Virginia, Соединенные Штаты, 23507
        • Рекрутинг
        • EVMS at Old Dominion University
        • Контакт:
          • Laura Stone
          • Номер телефона: 757-388-6238
          • Электронная почта: stonelj@evms.edu
        • Главный следователь:
          • Kent Lam, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion 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. Females of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Screening).

  4. Must have a history of CRS and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:

    • nasal congestion
    • nasal discharge (anterior and/or posterior nasal discharge)
    • facial pain or pressure
    • reduction or loss of smell

  5. Must have endoscopic evidence of nasal mucosal disease, with edema, or purulent discharge bilaterally, or presence of bilateral disease on a prior computed tomography (CT) scan performed within 14 days of Visit 1.

  6. 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.

  7. 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.

  8. Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization.

  9. 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 2021 Global Initiative for Asthma Guidelines (GINA) for 1 month before Visit 1 (Screening), and are expected to remain on it throughout the study. Subjects receiving inhaled fluticasone alone or in combination may not participate in the PK sub-study.

  10. 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.

  11. Must be able to cease treatment with intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma) at the screening visit

  12. 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 Week 4 of the study.

  13. Must be able to use the exhalation delivery system (EDS) correctly; all subjects will be required to demonstrate correct use with the practice EDS at Visit 1 (Screening).

  14. Must be capable, in the opinion of the investigator, of providing assent and parent or guardian must provide 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 that they are willing to participate in the study.

Exclusion Criteria:

  1. Females 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. History of sinus or nasal surgery within 6 months before Visit 1 or has not healed from a prior sinus or nasal surgery.
  7. Have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinus is completely opacified and either the margins are expanded and/or thinned OR there are areas of complete bone resorption resulting in bony defect and extension of the "mass" into adjacent tissues), evidence of allergic fungal sinusitis, or evidence of complicated sinus disease (including, but not limited to, extension of inflammation outside of the sinuses and nasal cavity).
  8. Have a paranasal sinus or nasal tumor.
  9. Have a nasal polyp score of grade 1 or greater in either nostril as determined by the nasoendoscopy at screening.
  10. Have a nasal septum perforation.
  11. Have had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Screening).
  12. Have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) on Visit 1 (Screening) nasal examination/nasoendoscopy.
  13. Have current, ongoing rhinitis medicamentosa (rebound rhinitis).
  14. Have significant oral structural abnormalities (eg, a cleft palate).
  15. Have a diagnosis of cystic fibrosis.
  16. History of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).
  17. Symptom resolution or last dose of antibiotics for purulent nasal infection, acute sinusitis, or upper respiratory tract infection, influenza, or SARS-CoV-2 (COVID-19) has not occurred before Visit 1. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution.
  18. Planned sinonasal surgery during the period of the study.
  19. Allergy, hypersensitivity, or contraindication to corticosteroids or steroids.
  20. Has used oral steroids in the past for treatment of CS and did not experience any relief of symptoms.
  21. Has a steroid eluting sinus stent still in place within 30 days of Visit 1.
  22. Allergy or hypersensitivity to any excipients in study drug.
  23. Exposure to any glucocorticoid treatment with potential for systemic effects (eg, oral, parenteral) within 1 month before Visit 1 (Screening); except as noted in inclusion criteria for subjects with comorbid asthma or COPD.
  24. Have nasal or oral candidiasis.
  25. History or current diagnosis of any form of glaucoma or ocular hypertension.
  26. History of IOP elevation on any form of steroid therapy.
  27. History or current diagnosis of the presence (in either eye) of a cataract unless both natural intraocular lenses have been removed.
  28. History of immunodeficiency of any etiology (including poor nutrition) that would be anticipated to affect the likelihood of benefit or harm from the therapeutic intervention.
  29. 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.
  30. Have a positive drug screen or a 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.
  31. Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening).
  32. Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), benralizumab (Fasenra™), Tezepelumab-ekko (Tezspire®) or any other immune-modifying monoclonal antibody within 6 months of Visit 1 (Screening).
  33. Is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole, cobicistat).
  34. Has a parent, guardian or caregiver who 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.
  35. Patients who report unexplained worsening of vision within the past 3 months.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo BID

Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks
Лекарство: Placebo

Placebo solution administered via exhalation delivery system (EDS).
Активный компаратор: OPN-375 186 µg BID

Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks
Лекарство: OPN-375

OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline to the end of Week 4 in the average instantaneous CSS (evaluation of symptom severity immediately preceding the time of scoring).
Временное ограничение: 4 Weeks

The CSS consists of the sum of the scores (0-3) assigned to each of the following symptoms of CRS: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The total CSS for each day can range from 0 to 9. Participants will report symptom severity immediately preceding the time of scoring every morning (AM). The baseline CSS is the average of the CSS's over the last 7 days of the single-blind run-in period. The end of Week 4 CSS is the average of the CSS's over the 7 days before Week 4.
4 Weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Frequency of acute exacerbations of CRS over the 12-week treatment period
Временное ограничение: 12 weeks

Acute exacerbations of CRS (AECRS) are defined as a worsening of symptoms that requires an escalation of treatment. The number of AECRS experienced by each participant will be recorded.
12 weeks
Change from baseline to the end of Week 4 on CSS score in subjects using an intranasal steroid treatment for CRS within 30 days of Visit 1/Screening
Временное ограничение: 4 Weeks

The CSS consists of the sum of the scores (0-3) assigned to each of the following symptoms of CRS: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The total CSS for each day can range from 0 to 9. Participants will report symptom severity immediately preceding the time of scoring every morning (AM). The baseline CSS is the average of the CSS's over the last 7 days of the single-blind run-in period. The end of Week 4 CSS is the average of the CSS's over the 7 days before Week 4. This outcome will assess this change in CSS specifically in the subgroup of participants who were symptomatic at trial entry despite reported use of an intranasal steroid for treatment of CRS within 30 days of Visit 1/Screening.
4 Weeks
Change from baseline to the end of Weeks 8 and 12 in CSS
Временное ограничение: 8 Weeks; 12 Weeks

The CSS consists of the sum of the scores (0-3) assigned to each of the following symptoms of CRS: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The total CSS for each day can range from 0 to 9. Participants will report symptom severity immediately preceding the time of scoring every morning (AM). The baseline CSS is the average of the CSS's over the last 7 days of the single-blind run-in period. The CSS for the end of Week 8 and Week 12 is the average of the CSS's over the 7 days before Week 8 and Week 12, respectively.
8 Weeks; 12 Weeks
Change from baseline to the end of Weeks 4, 8 and 12 in four separate cardinal CRS symptoms
Временное ограничение: 4 Weeks; 8 Weeks; 12 Weeks

Participants will rate each of the following four cardinal symptoms of CRS every morning based on symptom severity immediately before reporting: nasal congestion, facial pain or pressure sensation, nasal discharge (anterior and/or posterior), and sense of smell. Participants will rate each symptom on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. Scores from the 7 days immediately preceding each timepoint will be averaged. The change in 7-day average score from baseline to Week 4, Week 8, and Week 12 for each symptom will be assessed individually.
4 Weeks; 8 Weeks; 12 Weeks
Percent of subjects indicating improvement on the Patient Global Impression of Change (PGIC) at Week 12/ end of study.
Временное ограничение: 12 Weeks

The Patient Global Impression of Change (PGIC) survey consists of a single question asking participants to rate how much their symptoms have changed since beginning use of the study drug on a scale of 1 to 7, where 1 = Very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The percent of subjects indicating any improvement (minimal, much, or very much) will be assessed.
12 Weeks
Change from baseline to Week 12 in the 5 domains of the SN-5 Questionnaire
Временное ограничение: 12 Weeks

The SN-5 questionnaire is a quality of life assessment that will be completed by the participant/parent. There are 5 specific symptom related questions (answered on a 7-point Likert scale on frequency of symptoms, where 1 = none of the time and 7 = all of the time), and 1 general quality of life question, answered on a visual analog scale from 0 (worst) to 10 (best). For this outcome, the change in score from baseline to Week 12/end of participation will be assessed for each of the 5 symptom related questions.
12 Weeks
Change from baseline to Week 12 in overall quality of life as measured by the SN-5 Questionnaire
Временное ограничение: 12 Weeks

The SN-5 questionnaire is a quality of life assessment that will be completed by the participant/parent. There are 5 specific symptom related questions (answered on a 7-point Likert scale on frequency of symptoms, where 1 = none of the time and 7 = all of the time), and 1 general quality of life question, answered on a visual analog scale from 0 (worst) to 10 (best). This outcome will assess the change in score from baseline to Week 12/end of participation for general quality of life question.
12 Weeks

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Assessment of safety through Adverse Events (AEs)
Временное ограничение: 12 Weeks

Safety will be assessed by reporting frequency and severity (mild, moderate, or severe) of AEs experienced by participants during the trial. AEs will be collected beginning at time of signing of the Informed Consent Form (ICF) through end of participation (Week 12 or early termination).
12 Weeks
Assessment of safety by nasal examination
Временное ограничение: 12 Weeks

Nasal examinations will be completed on all participants via nasoendoscopy at screening and end of study (Week 12 or early termination). Physicians performing the nasoendoscopies will record the presence of epistaxis, septal erosion/perforation, and details related to ulceration/erosion of any area other than the septum. The frequency and severity of findings from these exams will be reported.
12 Weeks
Assessment of safety by ocular examination visual acuity
Временное ограничение: 12 Weeks

Ocular examinations will be performed during screening period and end of participation (Week 12 or early termination), and will include an assessment of visual acuity. Visual acuity will be assessed using an eye chart (EVA, EDTRS or Snellen) and will be recorded for each eye in the form of a fraction: 20/x.
12 Weeks
Assessment of safety by ocular examination intraocular pressure (IOP)
Временное ограничение: 12 Weeks

Ocular examinations will be performed during screening period and end of participation (Week 12 or early termination), and will include an assessment of intraocular pressure. Intraocular pressure will be assessed using a Goldmann applanation tonometer mounted on a slit lamp, a hand-held applanation Goldmann-type tonometer, or a Tono-Pen. Two measurements will be performed for each eye. If the first 2 measurements differ by more than 3 mm Hg, a third measurement will be performed. The average value of the 2 or 3 measurements will be calculated. Subjects in whom IOP is elevated above 21 mm Hg will not be enrolled. Any new occurrence of intraocular pressure elevation above 21 mm Hg will require subject withdrawal.
12 Weeks
Assessment of safety by ocular examination for cataracts
Временное ограничение: 12 Weeks

Ocular examinations will be performed during screening period and end of participation (Week 12 or early termination), and will include an assessment of presence of cataracts. Each of the participant's eyes will be assessed for the presence of cataracts. If a cataract is identified, it will be specified based on type (nuclear, cortical, or posterior subcapsular) and assigned a grade of 1, 1+, 2, 2+, 3, 3+, or 4. Participants with cataracts at screening will not be enrolled. Any new occurrence of cataracts of any grade will require withdrawal from the study.
12 Weeks
Assessment of safety by weight measurement
Временное ограничение: 12 Weeks

Participant weight will be collected at screening, randomization and end of participation (Week 12 or early termination). Weight will be measured in kilograms or pounds and findings will be summarized using descriptive statistics including mean values and change from baseline values, as well as numbers of subjects with values outside limits of the normal range at each time point.
12 Weeks
Assessment of safety by measuring vital signs - blood pressure
Временное ограничение: 12 Weeks

Participant blood pressure measurements will be collected at screening, randomization and end of participation (Week 12 or early termination). Systolic and diastolic blood pressure measurements will be collected in millimeter of mercury (mmHg) and findings will be summarized using descriptive statistics including mean values and change from baseline values, as well as numbers of subjects with values outside limits of the normal range at each time point.
12 Weeks
Assessment of safety by measuring vital signs - pulse
Временное ограничение: 12 Weeks

Participant heart rate will be collected at screening, randomization and end of participation (Week 12 or early termination). Heart rate will be measured in beats per minute (bpm) and findings will be summarized using descriptive statistics including mean values and change from baseline values, as well as numbers of subjects with values outside limits of the normal range at each time point.
12 Weeks
Assessment of safety through collection of concomitant medication usage information
Временное ограничение: 12 Weeks

Use of concomitant medications and related information will be collected from time of ICF signing through end of participation (Week 12 or early termination). Concomitant medications will be coded using the World Health Organization (WHO) Drug Dictionary (WHODrug) and summarized by drug class with subject counts and percent.
12 Weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Optinose US Inc.

Соавторы

Paratek Pharmaceuticals Inc

Следователи

  • Учебный стул: Amy Manley, Paratek Pharma

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 июля 2025 г.

Первичное завершение (Оцененный)

31 марта 2028 г.

Завершение исследования (Оцененный)

31 октября 2028 г.

Даты регистрации исследования

Первый отправленный

14 февраля 2025 г.

Впервые представлено, что соответствует критериям контроля качества

24 февраля 2025 г.

Первый опубликованный (Действительный)

27 февраля 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • OPN-FLU-CS-3207

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться