Trial · NCT06850805
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
NCT06850805, Phase 3, Recruiting, Optinose US Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps. Trials, record NCT06850805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06850805
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
- NCT number
- NCT06850805
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 84 participants, estimated
- Lead sponsor
- Optinose US Inc.
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps
- Interventions
- OPN-375, Placebo
- First posted
- 2025-02-27
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to the end of Week 4 in the average instantaneous CSS (evaluation of symptom severity immediately preceding the time of scoring). | 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. |
| Secondary | Frequency of acute exacerbations of CRS over the 12-week treatment period | 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. |
| Secondary | 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 | 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. |
| Secondary | Change from baseline to the end of Weeks 8 and 12 in CSS | 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. |
| Secondary | Change from baseline to the end of Weeks 4, 8 and 12 in four separate cardinal CRS symptoms | 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. |
| Secondary | Percent of subjects indicating improvement on the Patient Global Impression of Change (PGIC) at Week 12/ end of study. | 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. |
| Secondary | Change from baseline to Week 12 in the 5 domains of the SN-5 Questionnaire | 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. |
| Secondary | Change from baseline to Week 12 in overall quality of life as measured by the SN-5 Questionnaire | 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. |
| Other | Assessment of safety through Adverse Events (AEs) | 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). |
| Other | Assessment of safety by nasal examination | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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