Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Skuteczność i bezpieczeństwo 186 mcg sprayu nosowego OPN-375 dwa razy dziennie (BID) u nastolatków z przewlekłym zapaleniem nosa (Re-Open 3)

15 września 2026 zaktualizowane przez: Optinose US Inc.

12-tygodniowe randomizowane, podwójnie ślepe, kontrolowane placebo, wieloośrodkowe badanie oceniające skuteczność i bezpieczeństwo podawania donosowego 186 mcg OPN-375 dwa razy dziennie (BID) u młodzieży z przewlekłym zapaleniem nosa

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

84

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Huntsville, Alabama, Stany Zjednoczone, 35801
        • Jeszcze nie rekrutacja
        • North Alabama ENT
        • Kontakt:
        • Główny śledczy:
          • Jasper Castillo, MD
    • Arizona
      • Gilbert, Arizona, Stany Zjednoczone, 85214
        • Wycofane
        • San Tan Allergy & Asthma
    • California
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Jeszcze nie rekrutacja
        • Childrens Hospital of Los Angeles
        • Kontakt:
        • Główny śledczy:
          • Elisabeth Ference, MD
      • Orange, California, Stany Zjednoczone, 92868
        • Rekrutacyjny
        • Children's Hospital of Orange County
        • Kontakt:
        • Główny śledczy:
          • Jay Bhatt, MD
      • Sacramento, California, Stany Zjednoczone, 95661
        • Rekrutacyjny
        • DaVinci Research, LLC
        • Kontakt:
        • Główny śledczy:
          • Randall Ow, MD
      • San Diego, California, Stany Zjednoczone, 92123
        • Jeszcze nie rekrutacja
        • Rady Childrens Hospital San Diego
        • Główny śledczy:
          • Vijay Patel, MD
        • Kontakt:
      • Torrance, California, Stany Zjednoczone, 90503
        • Rekrutacyjny
        • Breathe Clear Institute
        • Główny śledczy:
          • Steven Davis, MD
        • Kontakt:
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • Rekrutacyjny
        • Children's Hospital Colorado
        • Główny śledczy:
          • Sarah Gitomer, MD
        • Kontakt:
      • Colorado Springs, Colorado, Stany Zjednoczone, 80909
        • Rekrutacyjny
        • Colorado ENT & Allergy
        • Kontakt:
        • Główny śledczy:
          • Bryan Davis, MD
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30329
        • Jeszcze nie rekrutacja
        • Children's Healthcare of Atlanta
        • Kontakt:
        • Główny śledczy:
          • Lori Gentile, MD
    • Illinois
      • Springfield, Illinois, Stany Zjednoczone, 62702
        • Rekrutacyjny
        • Southern Illinois University School of Medicine
        • Kontakt:
        • Główny śledczy:
          • Dana Crosby, MD
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40205
        • Rekrutacyjny
        • Kentuckiana ENT
        • Główny śledczy:
          • Thomas Higgins, MD
        • Kontakt:
    • Maryland
      • Towson, Maryland, Stany Zjednoczone, 21204
        • Rekrutacyjny
        • Centers for Advanced ENT Care
        • Kontakt:
        • Główny śledczy:
          • Douglas Reh, MD
    • Missouri
      • Columbia, Missouri, Stany Zjednoczone, 65212
        • Rekrutacyjny
        • University of Missouri Medical Center
        • Kontakt:
        • Główny śledczy:
          • Christine Franzese, MD
    • New York
      • Rochester, New York, Stany Zjednoczone, 14642
        • Rekrutacyjny
        • University of Rochester Medical Center
        • Kontakt:
        • Główny śledczy:
          • Li-Xing Man, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
        • Rekrutacyjny
        • Allergy, Asthma and Clinical Research Center
        • Główny śledczy:
          • Martha Tarpay, MD
        • Kontakt:
      • Tulsa, Oklahoma, Stany Zjednoczone, 74136
        • Rekrutacyjny
        • Vital Prospects Clinical Research Institute
        • Główny śledczy:
          • Iftikhar Hussain, MD
        • Kontakt:
    • South Carolina
      • North Charleston, South Carolina, Stany Zjednoczone, 29414
        • Rekrutacyjny
        • Charleston ENT & Allergy
        • Główny śledczy:
          • Thomas Murphy, MD
        • Kontakt:
      • Orangeburg, South Carolina, Stany Zjednoczone, 29118
        • Rekrutacyjny
        • Carolina ENT Clinic/CENTRI Inc.
        • Kontakt:
        • Główny śledczy:
          • John Ansley, MD
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78759
        • Rekrutacyjny
        • Orion Clinical Research
        • Kontakt:
        • Główny śledczy:
          • William Howland, III, MD
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Rekrutacyjny
        • STAAMP Research
        • Główny śledczy:
          • Erika Gonzalez, MD
        • Kontakt:
      • San Antonio, Texas, Stany Zjednoczone, 78258
        • Rekrutacyjny
        • Alamo ENT Associates
        • Kontakt:
        • Główny śledczy:
          • Jeffrey Rosenbloom, MD
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84112
        • Rekrutacyjny
        • University of Utah
        • Główny śledczy:
          • Jill Jeffe, MD
        • Kontakt:
    • Virginia
      • Norfolk, Virginia, Stany Zjednoczone, 23507
        • Rekrutacyjny
        • EVMS at Old Dominion University
        • Kontakt:
        • Główny śledczy:
          • Kent Lam, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo BID

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

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

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

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to the end of Week 4 in the average instantaneous CSS (evaluation of symptom severity immediately preceding the time of scoring).
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Frequency of acute exacerbations of CRS over the 12-week treatment period
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Assessment of safety through Adverse Events (AEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Optinose US Inc.

Współpracownicy

Paratek Pharmaceuticals Inc

Śledczy

  • Krzesło do nauki: Amy Manley, Paratek Pharma

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 lipca 2025

Zakończenie podstawowe (Szacowany)

31 marca 2028

Ukończenie studiów (Szacowany)

31 października 2028

Daty rejestracji na studia

Pierwszy przesłany

14 lutego 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 lutego 2025

Pierwszy wysłany (Rzeczywisty)

27 lutego 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • OPN-FLU-CS-3207

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj