Trial · NCT01624662
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
NCT01624662, Phase 3, Completed, Optinose US Inc.; results first posted 2018-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device. Trials, record NCT01624662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01624662
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
- NCT number
- NCT01624662
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Bilateral Nasal Polyposis
- Interventions
- Fluticasone propionate
- First posted
- 2012-06-21
- Last updated
- 2018-12-05
- Results first posted
- 2018-12-05
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | Baseline, Week 4 of the double-blind treatment phase | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 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 During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subject. Subjects reported both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptoms severity over the previous 12 hours) scores for nasal congestion/obstruction symptoms. |
| Primary | Change in Total Polyp Grade | Baseline, Week 16 of the double-blind treatment phase | Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy |
| Secondary | Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | Measured by the 7-day average instantaneous morning diary symptom scores |
| Secondary | Change in Rhinorrhea Score (7-day Instantaneous Morning) | Baseline, Week 16 of the double-blind treatment phase | Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores |
| Secondary | Facial Pain or Pressure Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | Change from baseline in facial pain/pressure symptoms, as measured by AM and PM diary symptom scores |
| Secondary | Hyposmia Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | Change from baseline in hyposmia symptoms, as measured by AM and PM diary symptom scores |
| Secondary | Change in Total Nasal Polyp Score | Baseline, Week 24 of the open-label extension phase | 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 border 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 Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy) |
| Secondary | Polyp Grade of 0 in at Least One Nostril | Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase | Subjects with a Polyp Grade of 0 (None) in at least one nostril Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border 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 | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase | SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. 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 | MOS Sleep-R Score | Baseline, Week 16 of the double-blind treatment phase | The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | Baseline, Week 4 of the double-blind treatment phase | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Total Polyp Grade | Baseline, Week 16 of the double-blind treatment phase | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Rhinorrhea Score (7-day Instantaneous Morning) | Baseline, Week 16 of the double-blind treatment phase | Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Facial Pain or Pressure Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Hyposmia Score (7-day Instantaneous Morning) | Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Total Nasal Polyp Score | Baseline, Week 24 of the open-label extension phase | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Polyp Grade of 0 in at Least One Nostril | Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MOS Sleep-R Score | Baseline, Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | Placebo | -0.24 | Standard Error 0.07 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 100 mcg | -0.59 | Standard Error 0.07 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 200 mcg | -0.68 | Standard Error 0.07 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 400 mcg | -0.62 | Standard Error 0.07 | units on a scale | |
| Change in Total Polyp Grade | Placebo | -0.61 | Standard Error 0.11 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 100 mcg | -1.31 | Standard Error 0.11 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 200 mcg | -1.22 | Standard Error 0.11 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 400 mcg | -1.41 | Standard Error 0.10 | units on a scale | |
| Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | Placebo | -0.48 | Standard Error 0.09 | units on a scale | |
| Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | OPN-375 100 mcg | -0.99 | Standard Error 0.09 | units on a scale |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | Placebo | 80 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | OPN-375 100 mcg | 81 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | OPN-375 200 mcg | 80 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | OPN-375 400 mcg | 82 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | Placebo | 70 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | OPN-375 100 mcg | 78 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | OPN-375 200 mcg | 76 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | OPN-375 400 mcg | 82 | |
| Double-Blind Treatment Phase (Wks 1-16) | NOT COMPLETED | Placebo | 10 | |
| Double-Blind Treatment Phase (Wks 1-16) | NOT COMPLETED | OPN-375 100 mcg | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events105
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 | Toothache | Gastrointestinal disorders | Placebo (Double-blind Phase) | 1 | 79 | |
| other | Toothache | Gastrointestinal disorders | OPN-375 100 mcg (Double-blind Phase) | 0 | 80 | |
| other | Toothache | Gastrointestinal disorders | OPN-375 200 mcg (Double-blind Phase) | 0 | 80 | |
| other | Toothache | Gastrointestinal disorders | OPN-375 400 mcg (Double-blind Phase) | 2 | 82 | |
| other | Toothache | Gastrointestinal disorders | OPN-375 400 mcg (Open-label Phase) | 0 | 299 | |
| other | Acute sinusitis | Infections and infestations | Placebo (Double-blind Phase) | 2 | 79 | |
| other | Acute sinusitis | Infections and infestations | OPN-375 100 mcg (Double-blind Phase) | 0 | 80 | |
| other | Acute sinusitis | Infections and infestations | OPN-375 200 mcg (Double-blind Phase) | 1 | 80 | |
| other | Acute sinusitis | Infections and infestations | OPN-375 400 mcg (Double-blind Phase) | 0 | 82 | |
| other | Acute sinusitis | Infections and infestations | OPN-375 400 mcg (Open-label Phase) | 3 | 299 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Double-blind Phase) | ||
| Total, all-cause mortality | OPN-375 100 mcg (Double-blind Phase) | ||
| Total, all-cause mortality | OPN-375 200 mcg (Double-blind Phase) | ||
| Total, all-cause mortality | OPN-375 400 mcg (Double-blind Phase) | ||
| Total, all-cause mortality | OPN-375 400 mcg (Open-label Phase) | ||
| Total, other adverse events | Placebo (Double-blind Phase) | 38 | 79 |
| Total, other adverse events | OPN-375 100 mcg (Double-blind Phase) | 39 | 80 |
| Total, other adverse events | OPN-375 200 mcg (Double-blind Phase) | 39 | 80 |
| Total, other adverse events | OPN-375 400 mcg (Double-blind Phase) | 46 | 82 |
| Total, other adverse events | OPN-375 400 mcg (Open-label Phase) | 60 | 299 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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/NCT01624662
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