Trial · NCT03960580
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps
NCT03960580, Phase 3, Completed, Optinose US Inc.; results first posted 2023-12-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps. Trials, record NCT03960580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03960580
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps
- NCT number
- NCT03960580
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 223 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Chronic Rhinosinusitis
- Interventions
- OPN-375
- First posted
- 2019-05-23
- Last updated
- 2023-12-21
- Results first posted
- 2023-12-21
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 | 4 Weeks | Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9. |
| Primary | Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses. | Baseline, Week 24 | Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%. |
| Secondary | Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | Baseline, Week 4 | The 4 individual CRS symptoms are: congestion, facial pain or pressure sensation, nasal discharge (anterior and/or posterior), and sense of smell. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. The scores at baseline and week 4 are calculated by averaging the score reported for the individual symptom over 7 days prior to the timepoint. The value provided in the results is calculated by subtracting the score at Week 4 from the score at Baseline; therefore, scores reported here can range from -3 to 3. |
| Secondary | Time to First Acute Exacerbation of Chronic Sinusitis | 24 Weeks | Comparing the distribution of time to first acute exacerbation of chronic sinusitis across treatment groups. An exacerbation of chronic sinusitis is defined as a worsening of symptoms that requires escalation of treatment. |
| Secondary | Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | 24 Weeks | The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, extra-nasal rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. The score range for each domain are as follows: Rhinologic: 0-30; Extra-nasal rhinologic: 0-15; Ear/facial: 0-25; Psychological dysfunction: 0-35; Sleep dysfunction: 0-25. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be, and total scores are calculated by adding scores together. The values reported here are calculated by subtracting the score reported at baseline from the score reported at Week 24 and, therefore, can range from the negative maximum score value to the positive maximum score value. |
| Secondary | Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. | 8 weeks, 12 weeks. | Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Range of scores for each symptom is 0=none, 1=mild, 2=moderate, 3=severe. The composite score is the sum of the 3 symptom scores and will range from 0-9. Scores reported at each timepoint are the averaged total instantaneous AM scores over the last 7 days before the given timepoint. The values presented here are calculated by subtracting the score at Baseline from Week 8 and Week 12, respectively. |
| Secondary | Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores | 8 Weeks; 12 Weeks | Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) symptoms. The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living. |
| Secondary | Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) scores. The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living |
| Secondary | Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) symptoms. The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living. |
| Secondary | Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) symptoms. The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 | 4 Weeks | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses. | Baseline, Week 24 | Full Analysis Set | percentage of opacification | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | Baseline, Week 4 | Full analysis set. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Acute Exacerbation of Chronic Sinusitis | 24 Weeks | Full analysis set. | Weeks | MEAN |
| SECONDARY | Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | 24 Weeks | Full analysis set. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. | 8 weeks, 12 weeks. | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores | 8 Weeks; 12 Weeks | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores | Baseline, Week 8, Week 12 | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group315
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 | Placebo | -0.81 | Standard Error 0.202 | score on a scale | |
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 | OPN-375 186 μg BID | -1.54 | Standard Error 0.204 | score on a scale | |
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4 | OPN-375 372 μg BID | -1.74 | Standard Error 0.204 | score on a scale | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses. | Placebo | 1.19 | Standard Error 1.740 | percentage of opacification | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses. | OPN-375 186 μg BID | -7.00 | Standard Error 1.725 | percentage of opacification | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified (APOV) in the Ethmoid and Maxillary Sinuses. | OPN-375 372 μg BID | -5.14 | Standard Error 1.742 | percentage of opacification | |
| Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | Placebo | Congestion/Obstruction | -0.26 | Standard Error 0.076 | score on a scale |
| Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | OPN-375 186 μg BID | Congestion/Obstruction | -0.60 | Standard Error 0.077 | score on a scale |
| Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | OPN-375 372 μg BID | Congestion/Obstruction | -0.70 | Standard Error 0.077 | score on a scale |
| Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). | Placebo | Nasal Discharge | -0.27 | Standard Error 0.076 | score on a scale |
1 to 10 of 315Source ClinicalTrials.gov
See all 315 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | STARTED | OPN-375 186 μg BID | 74 | |
| Overall Study | STARTED | OPN-375 372 μg BID | 74 | |
| Overall Study | COMPLETED | Placebo | 69 | |
| Overall Study | COMPLETED | OPN-375 186 μg BID | 70 | |
| Overall Study | COMPLETED | OPN-375 372 μg BID | 71 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | OPN-375 186 μg BID | 4 | |
| Overall Study | NOT COMPLETED | OPN-375 372 μg BID | 3 |
Source ClinicalTrials.gov
Adverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract nuclear | Eye disorders | Placebo | 2 | 75 | |
| other | Cataract nuclear | Eye disorders | OPN-375 186 μg BID | 0 | 73 | |
| other | Cataract nuclear | Eye disorders | OPN-375 372 μg BID | 0 | 74 | |
| other | Pyrexia | General disorders | Placebo | 2 | 75 | |
| other | Pyrexia | General disorders | OPN-375 186 μg BID | 0 | 73 | |
| other | Pyrexia | General disorders | OPN-375 372 μg BID | 2 | 74 | |
| other | COVID-19 | Infections and infestations | Placebo | 2 | 75 | |
| other | COVID-19 | Infections and infestations | OPN-375 186 μg BID | 3 | 73 | |
| other | COVID-19 | Infections and infestations | OPN-375 372 μg BID | 7 | 74 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 75 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 75 |
| Total, all-cause mortality | OPN-375 186 μg BID | 0 | 73 |
| Total, all-cause mortality | OPN-375 372 μg BID | 0 | 74 |
| Total, other adverse events | Placebo | 31 | 75 |
| Total, other adverse events | OPN-375 186 μg BID | 17 | 73 |
| Total, other adverse events | OPN-375 372 μg BID | 43 | 74 |
| Total, serious adverse events | Placebo | 0 | 75 |
| Total, serious adverse events | OPN-375 186 μg BID | 1 | 73 |
| Total, serious adverse events | OPN-375 372 μg BID | 4 | 74 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
GET https://conductscience.org/api/trials/v1/NCT03960580
GET https://conductscience.org/api/trials/v1/NCT03960580/registered?page=2