Trial · NCT03781804
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
NCT03781804, Phase 3, Completed, Optinose US Inc.; results first posted 2023-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps. Trials, record NCT03781804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03781804
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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 With or Without the Presence of Nasal Polyps
- NCT number
- NCT03781804
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 332 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Chronic Rhinosinusitis
- Interventions
- OPN-375
- First posted
- 2018-12-20
- Last updated
- 2024-05-29
- Results first posted
- 2023-09-18
Source ClinicalTrials.gov
Registered outcomes41
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 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 Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | Week 24 | 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, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. 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. |
| Secondary | 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) | Week 12 | 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. 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. |
| Secondary | Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores | 12 Weeks | Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), 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 in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores | 12 Weeks | Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12). |
| Secondary | Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores | 12 Weeks | Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). 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 in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores | 12 Weeks | Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). 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. The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12). |
| Secondary | Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations | 24 Weeks | Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, 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 24/ET in the Lund-Mackay Staging System Total Score | Baseline, Week 24 | Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
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 in the Ethmoid and Maxillary Sinuses | Baseline, Week 24 | Full analysis set | Percentage of volume opacified | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | Week 24 | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Week 12 | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores | 12 Weeks | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores | 12 Weeks | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores | 12 Weeks | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores | 12 Weeks | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations | 24 Weeks | Full analysis set | percentage of volume opacified | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score | Baseline, Week 24 | Full analysis set | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group267
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 | OPN-375 186 μg BID | -1.58 | Standard Error 0.161 | 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 | -1.60 | Standard Error 0.163 | 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 | Placebo | -0.62 | Standard Error 0.161 | score on a scale | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses | OPN-375 186 μg BID | -5.58 | Standard Error 1.436 | Percentage of volume opacified | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses | OPN-375 372 μg BID | -6.20 | Standard Error 1.412 | Percentage of volume opacified | |
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses | Placebo | -1.60 | Standard Error 1.421 | Percentage of volume opacified | |
| Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | OPN-375 186 μg BID | -18.05 | Standard Error 1.687 | score on a scale | |
| Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | OPN-375 372 μg BID | -22.77 | Standard Error 1.709 | score on a scale | |
| Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains | Placebo | -10.16 | Standard Error 1.723 | 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) | OPN-375 186 μg BID | -1.89 | Standard Error 0.204 | score on a scale |
1 to 10 of 267Source ClinicalTrials.gov
See all 267 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPN-375 186 μg BID | 111 | |
| Overall Study | STARTED | OPN-375 372 μg BID | 109 | |
| Overall Study | STARTED | Placebo | 112 | |
| Overall Study | COMPLETED | OPN-375 186 μg BID | 102 | |
| Overall Study | COMPLETED | OPN-375 372 μg BID | 101 | |
| Overall Study | COMPLETED | Placebo | 96 | |
| Overall Study | NOT COMPLETED | OPN-375 186 μg BID | 9 | |
| Overall Study | NOT COMPLETED | OPN-375 372 μg BID | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events54
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 | Epistaxis | Respiratory, thoracic and mediastinal disorders | OPN-375 186 μg BID | 5 | 111 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | OPN-375 372 μg BID | 13 | 109 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 112 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | OPN-375 186 μg BID | 5 | 111 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | OPN-375 372 μg BID | 4 | 109 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 112 | |
| other | Headache | Nervous system disorders | OPN-375 186 μg BID | 2 | 111 | |
| other | Headache | Nervous system disorders | OPN-375 372 μg BID | 3 | 109 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 112 | |
| other | Dizziness | Nervous system disorders | OPN-375 186 μg BID | 0 | 111 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPN-375 186 μg BID | 0 | 111 |
| Total, all-cause mortality | OPN-375 372 μg BID | 0 | 109 |
| Total, all-cause mortality | Placebo | 0 | 112 |
| Total, other adverse events | OPN-375 186 μg BID | 37 | 111 |
| Total, other adverse events | OPN-375 372 μg BID | 37 | 109 |
| Total, other adverse events | Placebo | 14 | 112 |
| Total, serious adverse events | OPN-375 186 μg BID | 1 | 111 |
| Total, serious adverse events | OPN-375 372 μg BID | 2 | 109 |
| Total, serious adverse events | Placebo | 3 | 112 |
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/NCT03781804
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