Trial · NCT01622569
Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
NCT01622569, Phase 3, Completed, Optinose US Inc.; results first posted 2018-12-05
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 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety. Trials, record NCT01622569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01622569
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 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
- NCT number
- NCT01622569
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- Optinose US Inc.
- Conditions
- Bilateral Nasal Polyposis
- Interventions
- Fluticasone Propionate
- First posted
- 2012-06-19
- Last updated
- 2018-12-26
- Results first posted
- 2018-12-05
Source ClinicalTrials.gov
Registered outcomes15
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 The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase |
| Primary | Change in Total Polyp Grade | Baseline, Week 16 of the double-blind treatment phase | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 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 Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline |
| Secondary | Congestion/Obstruction Scores (7-day Instantaneous Morning) | Baseline, Week 16 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 The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase |
| Secondary | Change in Rhinorrhea Score (7-day Instantaneous Morning) | Baseline, Week 16 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 The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase |
| Secondary | Facial Pain or Pressure Score (7-day Instantaneous Morning) | Baseline, Week 16 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 The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase |
| Secondary | Hyposmia Score (7-day Instantaneous Morning) | Baseline, Week 16 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 The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase |
| Secondary | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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. |
| Secondary | Rhinosinusitis Disability Index (RSDI) Total Score | Baseline, Week 16 of the double-blind treatment phase | The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function. |
| Secondary | SF-36v2 - Mental Component | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase | The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 | 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 |
| PRIMARY | Change in Total Polyp Grade | Baseline, Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Congestion/Obstruction Scores (7-day Instantaneous Morning) | Baseline, Week 16 of the double-blind treatment phase | 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 | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Facial Pain or Pressure Score (7-day Instantaneous Morning) | Baseline, Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Hyposmia Score (7-day Instantaneous Morning) | Baseline, Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Sinonasal Outcome Test 22 (SNOT-22) Total Score | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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 | |
| SECONDARY | Rhinosinusitis Disability Index (RSDI) Total Score | Baseline, Week 16 of the double-blind treatment phase | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | SF-36v2 - Mental Component | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group88
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 | -0.26 | Standard Deviation 0.08 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 100 μg BID | -0.53 | Standard Deviation 0.08 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 200 μg BID | -0.56 | Standard Deviation 0.08 | units on a scale | |
| Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms | OPN-375 400 μg BID | -0.67 | Standard Deviation 0.08 | units on a scale | |
| Change in Total Polyp Grade | Placebo | -0.57 | Standard Deviation 0.14 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 100 μg BID | -1.04 | Standard Deviation 0.14 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 200 μg BID | -1.14 | Standard Deviation 0.14 | units on a scale | |
| Change in Total Polyp Grade | OPN-375 400 μg BID | -1.14 | Standard Deviation 0.14 | units on a scale | |
| Congestion/Obstruction Scores (7-day Instantaneous Morning) | Placebo | -0.53 | Standard Deviation 0.11 | units on a scale | |
| Congestion/Obstruction Scores (7-day Instantaneous Morning) | OPN-375 100 μg Twice Daily | -0.93 | Standard Deviation 0.10 | units on a scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 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 | 82 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | 100 μg OPN-375 | 81 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | 200 μg OPN-375 | 80 | |
| Double-Blind Treatment Phase (Wks 1-16) | STARTED | 400 μg EDS-FLU | 80 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | Placebo | 70 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | 100 μg OPN-375 | 75 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | 200 μg OPN-375 | 71 | |
| Double-Blind Treatment Phase (Wks 1-16) | COMPLETED | 400 μg EDS-FLU | 76 | |
| Double-Blind Treatment Phase (Wks 1-16) | NOT COMPLETED | Placebo | 12 | |
| Double-Blind Treatment Phase (Wks 1-16) | NOT COMPLETED | 100 μg OPN-375 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events135
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 | Ear Pain | Ear and labyrinth disorders | Placebo (Double-Blind Phase) | 1 | 82 | |
| other | Ear Pain | Ear and labyrinth disorders | OPN-375 100 μg BID (Double-Blind Phase) | 2 | 81 | |
| other | Ear Pain | Ear and labyrinth disorders | OPN-375 200 μg BID (Double-Blind Phase) | 0 | 80 | |
| other | Ear Pain | Ear and labyrinth disorders | OPN-375 400 μg BID (Double-Blind Phase) | 0 | 79 | |
| other | Ear Pain | Ear and labyrinth disorders | OPN-375 400 μg (Open-Label Phase) | 1 | 282 | |
| other | Cataract Nuclear | Eye disorders | Placebo (Double-Blind Phase) | 2 | 82 | |
| other | Cataract Nuclear | Eye disorders | OPN-375 100 μg BID (Double-Blind Phase) | 1 | 81 | |
| other | Cataract Nuclear | Eye disorders | OPN-375 200 μg BID (Double-Blind Phase) | 0 | 80 | |
| other | Cataract Nuclear | Eye disorders | OPN-375 400 μg BID (Double-Blind Phase) | 0 | 79 | |
| other | Cataract Nuclear | Eye disorders | OPN-375 400 μg (Open-Label Phase) | 0 | 282 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 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) | 0 | 82 |
| Total, all-cause mortality | OPN-375 100 μg BID (Double-Blind Phase) | 0 | 81 |
| Total, all-cause mortality | OPN-375 200 μg BID (Double-Blind Phase) | 0 | 80 |
| Total, all-cause mortality | OPN-375 400 μg BID (Double-Blind Phase) | 0 | 79 |
| Total, all-cause mortality | OPN-375 400 μg (Open-Label Phase) | 0 | 282 |
| Total, other adverse events | Placebo (Double-Blind Phase) | 42 | 82 |
| Total, other adverse events | OPN-375 100 μg BID (Double-Blind Phase) | 40 | 81 |
| Total, other adverse events | OPN-375 200 μg BID (Double-Blind Phase) | 45 | 80 |
| Total, other adverse events | OPN-375 400 μg BID (Double-Blind Phase) | 50 | 79 |
| Total, other adverse events | OPN-375 400 μg (Open-Label Phase) | 38 | 282 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT01622569
GET https://conductscience.org/api/trials/v1/NCT01622569/results?page=2