Trial · NCT01623323
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
NCT01623323, Phase 3, Completed, Optinose US Inc.; results first posted 2016-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps. Trials, record NCT01623323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01623323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
- NCT number
- NCT01623323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 705 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Chronic Sinusitis With or Without Nasal Polyps
- Interventions
- Fluticasone Propionate
- First posted
- 2012-06-19
- Last updated
- 2016-08-29
- Results first posted
- 2016-03-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Baseline to 3 months or End of Study | Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events | Baseline to 3 months or End of Study | All subject who received at least one dose of study medication | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
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 | 270 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPN-375 | 705 | |
| Overall Study | COMPLETED | OPN-375 | 601 | |
| Overall Study | NOT COMPLETED | OPN-375 | 104 |
Source ClinicalTrials.gov
Adverse events8
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 | 102 | 705 | |
| other | Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | OPN-375 | 72 | 705 | |
| other | Nasal Septal Disorder | Respiratory, thoracic and mediastinal disorders | OPN-375 | 39 | 705 | |
| serious | acute cholecystitis | Hepatobiliary disorders | OPN-375 | 1 | 705 | 1 |
| serious | Cervix Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | OPN-375 | 1 | 705 | 1 |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | OPN-375 | 1 | 705 | 1 |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | OPN-375 | 1 | 705 | 1 |
| serious | Hypotension | Vascular disorders | OPN-375 | 1 | 705 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPN-375 | ||
| Total, other adverse events | OPN-375 | 180 | 705 |
| Total, serious adverse events | OPN-375 | 5 | 705 |
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/NCT01623323
GET https://conductscience.org/api/trials/v1/NCT01623323/registered