Trial · NCT01623310
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
NCT01623310, Phase 3, Completed, Optinose US Inc.; results first posted 2018-01-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device. Trials, record NCT01623310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01623310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
- NCT number
- NCT01623310
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 223 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Nasal Polyps
- Interventions
- Fluticasone Propionate
- First posted
- 2012-06-19
- Last updated
- 2018-01-24
- Results first posted
- 2018-01-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | 12 Months | Patients with at least one Adverse Events |
| Secondary | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Month 3, Month 12 | Change from baseline to Month 3 \& Month 12 in SNOT-22 Total Score SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. The total score can range from 0-110, 0 being the best and 110 being the worst. 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 | Lund-Mackay Total Score | Baseline, Month 3, Month 12 | Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline, Month 3, Month 12 | The PGIC took less than 1 minute to complete. Subjects answered question, "Since starting the study drug, how would you rate the change in your symptoms?" Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time. |
| Secondary | Summed Bilateral Nasal Polyp Grading Scale Score | Baseline, Month 3, Month 12 | In subjects with nasal polyps, polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate |
| Secondary | Nasal Polyp Surgery Eligibility | Baseline, Month 3, Month 12 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events | 12 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Month 3, Month 12 | The Safety Analysis Set included all subjects who received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | Lund-Mackay Total Score | Baseline, Month 3, Month 12 | The Safety Analysis Set included all subjects who received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) | Baseline, Month 3, Month 12 | The Safety Analysis Set included all subjects who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summed Bilateral Nasal Polyp Grading Scale Score | Baseline, Month 3, Month 12 | Includes Chronic Sinusitis with Nasal Polyp Patients | units on a scale | MEAN |
| SECONDARY | Nasal Polyp Surgery Eligibility | Baseline, Month 3, Month 12 | The Safety Analysis Set included all subjects who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events | OPN-375 400 μg | 169 | Participants | ||
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | OPN-375 400 μg | Change from BL to Month 3, Pts With Polyps | -16.7 | Standard Deviation 15.39 | units on a scale |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | OPN-375 400 μg | Change from BL to Month 3, Pts Without Polyps | -18.6 | Standard Deviation 20.06 | units on a scale |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | OPN-375 400 μg | Change from BL to Month 12, Pts With Polyps | -21.5 | Standard Deviation 21.81 | units on a scale |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | OPN-375 400 μg | Change from BL to Month 12, Pts Without Polyps | -21.1 | Standard Deviation 22.96 | units on a scale |
| Lund-Mackay Total Score | OPN-375 400 μg | Change from BL to Month 3, Pts With Polyps | -0.8 | Standard Deviation 1.35 | units on a scale |
| Lund-Mackay Total Score | OPN-375 400 μg | Change from BL to Month 3, Pts Without Polyps | -0.8 | Standard Deviation 1.21 | units on a scale |
| Lund-Mackay Total Score | OPN-375 400 μg | Change from BL to Month 12, Pts With Polyps | -0.7 | Standard Deviation 1.63 | units on a scale |
| Lund-Mackay Total Score | OPN-375 400 μg | Change from BL to Month 12, Pts Without Polyps | -0.8 | Standard Deviation 1.18 | units on a scale |
| Patient Global Impression of Change (PGIC) | OPN-375 400 μg | Month 3, Pts With Polyps | 27 | Participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPN-375 400 μg | 223 | |
| Overall Study | COMPLETED | OPN-375 400 μg | 144 | |
| Overall Study | NOT COMPLETED | OPN-375 400 μg | 79 |
Source ClinicalTrials.gov
Adverse events15
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 | Acute Sinusitis | Infections and infestations | Fluticasone | 31 | 223 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Fluticasone | 17 | 223 | |
| other | Bronchitis | Infections and infestations | Fluticasone | 6 | 223 | |
| other | Influenza | Infections and infestations | Fluticasone | 6 | 223 | |
| other | Nasopharyngitis | Infections and infestations | Fluticasone | 5 | 223 | |
| other | Intraocular Pressure Increase | Investigations | Fluticasone | 5 | 223 | |
| other | Headache | Nervous system disorders | Fluticasone | 21 | 223 | |
| other | Spontaneously Reported Epistaxis | Respiratory, thoracic and mediastinal disorders | Fluticasone | 25 | 223 | |
| other | Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | Fluticasone | 39 | 223 | |
| other | Nasal Septum Disorder | Respiratory, thoracic and mediastinal disorders | Fluticasone | 32 | 223 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone | 0 | 223 |
| Total, other adverse events | Fluticasone | 169 | 223 |
| Total, serious adverse events | Fluticasone | 0 | 223 |
Source ClinicalTrials.gov
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.
GET https://conductscience.org/api/trials/v1/NCT01623310
GET https://conductscience.org/api/trials/v1/NCT01623310/registered