A Phase 3 interventional study of OPN-375 in Chronic Rhinosinusitis, sponsored by Optinose US Inc.. Completed at 92 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Optinose US Inc. · Phase 3, Interventional, and Treatment
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.
The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate) with placebo in subjects with chronic rhinosinusitis using the following co-primary endpoints:
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 332 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Optinose US Inc. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Potential subjects must meet the following criteria to enter this study:
women of childbearing potential must be abstinent, or if sexually active,
must have a history of chronic rhinosinusitis (CRS) and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:
Potential subjects who meet any of the following criteria will be excluded from entering this study:
OPN-375 186 μg BID x 24 Weeks
Drug: OPN-375
OPN-375 372 μg BID x 24 Weeks
Drug: OPN-375
Matching Placebo BID x 24 Weeks
Drug: OPN-375
OPN-375, BID
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
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.
Time frame: 4 Weeks
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses
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%.
Time frame: Baseline, Week 24
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
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.
Time frame: Week 24
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)
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.
Time frame: Week 12
Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores
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.
Time frame: 12 Weeks
Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores
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).
Time frame: 12 Weeks
Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores
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.
Time frame: 12 Weeks
Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores
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).
Time frame: 12 Weeks
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
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%.
Time frame: 24 Weeks
Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score
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.
Time frame: Baseline, Week 24
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined
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 the ostiomeatal complex (OMC). The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 \[Wk 24\] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).
Time frame: 24 Weeks
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
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 the ostiomeatal complex (OMC). Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).
Time frame: Week 24
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment
Time frame: Baseline, Week 24
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment
Time frame: Baseline, Week 24
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.
Time frame: 24 Weeks
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.
Time frame: Baseline, Week 24
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.
Time frame: Baseline, Week 24
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).
Time frame: Baseline, Week 24
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%
Time frame: Baseline, Week 24
Time Comparison to First Acute Exacerbation of Chronic Sinusitis
Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment
Time frame: 24 Weeks
Percentage of Subjects Requiring Rescue Medication After Week 4
Recording of each dose of approved rescue medication after the Week 4 visit through Week 12
Time frame: 8 Weeks
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 "component" scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.
Time frame: 12 Weeks, 24 Weeks
Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)
Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse
Time frame: Week 4, Week 24
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.
Time frame: Week 24
Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)
Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Time frame: 24 Weeks
Change in the SF-36v2 Physical Composite Score (PCS)
Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Time frame: 24 Weeks
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.
Time frame: 24 Weeks
Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.
Time frame: 24 Weeks
Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™
The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.
Time frame: 24 Weeks
Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)
The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).
Time frame: 24 Weeks
Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument
The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).
Time frame: 24 Weeks
Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery
Percentage of subjects indicating that they are willing to consider Sinus Surgery
Time frame: Baseline, Week 24
Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention
Percentage of Subjects who meet the minimal objective criteria for surgical intervention
Time frame: Baseline, Week 24
Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery
Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.
Time frame: Week 24
Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).
The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. Values for this outcome are reported as the change in relative absenteeism (the percentage of productivity at work) from baseline to Week 24.
Time frame: 24 Weeks
Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe
Time frame: 24 Weeks
Evaluation of Safety-Nasal Examination
Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.
Time frame: 24 Weeks
Evaluation of Safety Measuring Vital Signs- Blood Pressure
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Time frame: 24 Weeks
Evaluation of Safety Measuring Vital Signs- Pulse
Measure pulse in beats per minute (bpm)
Time frame: 24 Weeks
Evaluation of Safety Measuring Vital Signs- Weight
Assessment of safety from physical examination-weight measured in kg or lb
Time frame: 24 Weeks
Evaluation of Safety - Monitoring Concomitant Medication Usage
Assessment for safety from the collection of information for concomitant medications usage
Time frame: 24 Weeks
| Milestone | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Started | 111 | 109 | 112 |
| Completed | 102 | 101 | 96 |
| Not completed | 9 | 8 | 16 |
| Withdrew: Adverse event | 2 | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
| Withdrew: Lack of efficacy | 4 | 2 | 9 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
| Withdrew: Reason not provided | 2 | 2 | 0 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| 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 | -1.58 ± 0.161 | -1.60 ± 0.163 | -0.62 ± 0.161 |
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%.
| Percentage of volume opacified | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses | -5.58 ± 1.436 | -6.20 ± 1.412 | -1.60 ± 1.421 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| 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 | -18.05 ± 1.687 | -22.77 ± 1.709 | -10.16 ± 1.723 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| 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) | -1.89 ± 0.204 | -2.18 ± 0.208 | -1.35 ± 0.208 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| AM Diary Score | -0.71 ± 0.074 | -0.84 ± 0.076 | -0.45 ± 0.076 |
| PM Diary Score | -0.68 ± 0.075 | -0.82 ± 0.076 | -0.41 ± 0.076 |
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).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| AM Diary Score | -0.60 ± 0.078 | -0.54 ± 0.079 | -0.31 ± 0.079 |
| PM Diary Score | -0.54 ± 0.078 | -0.56 ± 0.080 | -0.32 ± 0.079 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| AM Diary Score | -0.65 ± 0.075 | -0.74 ± 0.076 | -0.43 ± 0.077 |
| PM Diary Score | -0.58 ± 0.077 | -0.72 ± 0.078 | -0.37 ± 0.078 |
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).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| AM Diary Score | -0.53 ± 0.078 | -0.61 ± 0.079 | -0.48 ± 0.079 |
| PM Diary Score | -0.52 ± 0.077 | -0.57 ± 0.079 | -0.43 ± 0.078 |
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%.
| percentage of volume opacified | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Nasal Polyps Present | -6.01 ± 1.741 | -4.64 ± 1.744 | 1.29 ± 1.727 |
| Nasal Polyps Absent | -3.52 ± 2.389 | -7.90 ± 2.287 | -5.50 ± 2.309 |
| Prior Sinus Surgery | -7.58 ± 2.156 | -8.91 ± 2.235 | -1.65 ± 2.185 |
| No Prior Sinus Surgery | -3.30 ± 1.913 | -3.82 ± 1.787 | -0.95 ± 1.810 |
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.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score | -0.40 ± 0.269 | -0.46 ± 0.267 | 0.10 ± 0.266 |
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 the ostiomeatal complex (OMC). The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 \[Wk 24\] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined | 0.12 ± 0.148 | 0.04 ± 0.149 | 0.37 ± 0.148 |
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 the ostiomeatal complex (OMC). Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Ethmoid Sinus Anterior | 0.06 ± 0.064 | -0.01 ± 0.063 | 0.07 ± 0.064 |
| Ethmoid Sinus Posterior | 0.00 ± 0.066 | -0.04 ± 0.067 | 0.15 ± 0.068 |
| Maxillary Sinus | 0.04 ± 0.049 | 0.09 ± 0.051 | 0.12 ± 0.052 |
| Frontal Sinus | 0.08 ± 0.072 | 0.01 ± 0.071 | 0.01 ± 0.070 |
| Sphenoid Sinus | 0.04 ± 0.067 | -0.03 ± 0.068 | 0.08 ± 0.069 |
| Ostiomeatal Complex | -0.66 ± 0.129 | -0.47 ± 0.129 | -0.31 ± 0.129 |
| Percent opacified volume | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment | -14.70 ± 2.23 | -12.62 ± 2.3 | -7.61 ± 2.29 |
| Percent opacified volume | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment | -7.31 ± 1.43 | -7.43 ± 1.44 | -3.76 ± 1.44 |
Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.
| Percent opacified volume | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Full Population | -11.27 ± 1.81 | -10.39 ± 1.83 | -6.51 ± 1.82 |
| CRSwNP SubGroup | -6.54 ± 1.77 | -6.72 ± 1.81 | -3.23 ± 1.79 |
| CRSsNP SubGroup | -7.88 ± 2.37 | -7.89 ± 2.37 | -3.88 ± 2.34 |
| Subjects with Prior Sinus Surgery | -11.29 ± 2.67 | -12.44 ± 2.89 | -3.24 ± 2.85 |
| Subjects without Prior Sinus Surgery | -11.00 ± 2.46 | -8.83 ± 2.30 | -8.39 ± 2.33 |
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score | -0.98 ± 0.65 | -1.95 ± 0.64 | -0.03 ± 0.65 |
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined | -1.21 ± 0.43 | -1.44 ± 0.43 | -0.19 ± 0.42 |
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Anterior Ethmoid Sinus Pair | -0.39 ± 0.17 | -0.53 ± 0.17 | -0.19 ± 0.17 |
| Posterior Ethmoid Sinus Pair | -0.33 ± 0.18 | -0.55 ± 0.18 | 0.03 ± 0.18 |
| Maxillary Sinus Pair | -0.53 ± 0.18 | -0.39 ± 0.17 | -0.08 ± 0.17 |
| Frontal Sinus Pair | 0.12 ± 0.20 | -0.16 ± 0.20 | 0.05 ± 0.20 |
| Sphenoid Sinus Pair | 0.15 ± 0.20 | -0.16 ± 0.19 | 0.20 ± 0.19 |
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Total Population | -0.59 ± 0.11 | -0.60 ± 0.11 | -0.45 ± 0.11 |
| CRSwNP | -0.49 ± 0.13 | -0.57 ± 0.14 | -0.30 ± 0.14 |
| CRSsNP | -0.70 ± 0.18 | -0.61 ± 0.18 | -0.64 ± 0.18 |
| Subjects with Prior Sinus Surgery | -0.48 ± 0.16 | -0.78 ± 0.17 | -0.33 ± 0.17 |
| Subjects without Prior Sinus Surgery | -0.70 ± 0.15 | -0.51 ± 0.14 | -0.54 ± 0.14 |
Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment
| Weeks | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Time Comparison to First Acute Exacerbation of Chronic Sinusitis | 23.44 ± 0.55 | 17.19 ± 0.25 | 19.73 ± 0.69 |
Recording of each dose of approved rescue medication after the Week 4 visit through Week 12
No measurements were reported for this outcome.
The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 "component" scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Week 12 | -0.66 ± 0.291 | -1.48 ± 0.291 | -0.91 ± 0.294 |
| Week 24 | -1.12 ± 0.292 | -1.77 ± 0.294 | -1.09 ± 0.301 |
Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Week 4 | 84 | 77 | 57 |
| Week 24 | 78 | 80 | 56 |
The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS) | -0.24 ± 0.31 | -0.80 ± 0.31 | -0.62 ± 0.31 |
Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS) | -0.1 ± 0.810 | 1.65 ± 0.820 | 1.41 ± 0.834 |
Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in the SF-36v2 Physical Composite Score (PCS) | 2.37 ± 0.647 | 3.64 ± 0.652 | 1.58 ± 0.663 |
The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Physical Functioning Score | 1.07 ± 1.039 | 1.43 ± 1.055 | 0.04 ± 1.067 |
| Role Physical Score | 0.92 ± 1.057 | 2.64 ± 1.074 | 0.16 ± 1.082 |
| Bodily Pain Score | 0.94 ± 1.172 | 4.10 ± 1.185 | 1.8 ± 1.201 |
| General Health Score | 0.55 ± 1.091 | 2.38 ± 1.119 | -1.18 ± 1.21 |
| Vitality Score | 1.13 ± 1.142 | 3.35 ± 1.156 | 1.81 ± 1.168 |
| Social Functioning Score | 0.22 ± 1.153 | 2.05 ± 1.173 | 1.89 ± 1.181 |
| Role Emotional Score | -1.11 ± 1.147 | 1.2 ± 1.169 | -0.32 ± 1.178 |
| Mental Health Score | -0.92 ± 1.169 | 0.75 ± 1.188 | -0.69 ± 1.194 |
The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS) | -0.24 ± 0.308 | -0.80 ± 0.312 | -0.62 ± 0.314 |
The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™ | 2.47 ± 0.765 | 2.33 ± 0.768 | -1.30 ± 0.793 |
The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS) | 2.59 ± 1.783 | 3.97 ± 1.791 | -0.35 ± 1.810 |
The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).
| score on a scale | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument | 0 ± 0.016 | 0.04 ± 0.017 | 0.01 ± 0.016 |
Percentage of subjects indicating that they are willing to consider Sinus Surgery
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Baseline | 63 | 59 | 54 |
| Week 24 | 52 | 48 | 54 |
Percentage of Subjects who meet the minimal objective criteria for surgical intervention
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Baseline | 42 | 48 | 45 |
| Week 24 | 30 | 36 | 38 |
Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery | 52 | 56 | 48 |
The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. Values for this outcome are reported as the change in relative absenteeism (the percentage of productivity at work) from baseline to Week 24.
| percentage of productivity | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ). | 0.98 ± 2.384 | -4.13 ± 2.479 | -6.28 ± 2.505 |
Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Mild | 25 | 23 | 20 |
| Moderate | 29 | 26 | 33 |
| Severe | 3 | 3 | 5 |
Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Epistaxis — Present | 3 | 9 | 1 |
| Epistaxis — Absent | 105 | 96 | 102 |
| Septal Erosion/Perforation — Present | 3 | 3 | 0 |
| Septal Erosion/Perforation — Absent | 105 | 102 | 103 |
| Ulceration/Erosion (non-septum) — Present | 0 | 2 | 1 |
| Ulceration/Erosion (non-septum) — Absent | 108 | 103 | 102 |
| Mucosal Candidiasis — Present | 0 | 0 | 0 |
| Mucosal Candidiasis — Absent | 108 | 105 | 103 |
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
| mmHg | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Systolic Blood Pressure (mmHg) | 127.3 ± 14.15 | 126.7 ± 14.11 | 127.3 ± 14.69 |
| Diastolic Blood Pressure (mmHg) | 78.0 ± 8.22 | 78.2 ± 9.70 | 79.3 ± 8.62 |
Measure pulse in beats per minute (bpm)
| Beats per minute | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Evaluation of Safety Measuring Vital Signs- Pulse | 73.7 ± 11.96 | 72.7 ± 9.5 | 73.1 ± 9.45 |
Assessment of safety from physical examination-weight measured in kg or lb
| kg | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Evaluation of Safety Measuring Vital Signs- Weight | 82.81 ± 20.873 | 84.23 ± 19.232 | 83.84 ± 21.531 |
Assessment for safety from the collection of information for concomitant medications usage
| Participants | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| Amides | 33 | 38 | 30 |
| Adrenergics in Combination with Corticosteroids or other drugs | 35 | 30 | 27 |
| Ace Inhibitors, Plain | 5 | 7 | 12 |
| Allergen Extracts | 6 | 6 | 2 |
| Alpha-Adrenoreceptor Antagonists | 1 | 6 | 2 |
Collected over Pretreatment (Screening/Run-in) period to end of treatment (Week 24). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPN-375 186 μg BID | 0/111 (0%) | 1/111 (0.9%) | 37/111 (33.3%) |
| OPN-375 372 μg BID | 0/109 (0%) | 2/109 (1.8%) | 37/109 (33.9%) |
| Placebo | 0/112 (0%) | 3/112 (2.7%) | 14/112 (12.5%) |
| Event | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/111 | 0/109 | 2/112 |
| Alcoholic pancreatitisGastrointestinal disorders | 0/111 | 1/109 | 0/112 |
| Ankle fractureInjury, poisoning and procedural complications | 0/111 | 1/109 | 0/112 |
| PyrexiaGeneral disorders | 1/111 | 0/109 | 0/112 |
| Pneumonia staphylococcalInfections and infestations | 0/111 | 0/109 | 1/112 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/111 | 0/109 | 1/112 |
| AdenomyosisReproductive system and breast disorders | 0/111 | 0/109 | 1/112 |
| Ovarian cystReproductive system and breast disorders | 0/111 | 0/109 | 1/112 |
| Event | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo |
|---|---|---|---|
| EpistaxisRespiratory, thoracic and mediastinal disorders | 5/111 | 13/109 | 1/112 |
| Cataract corticalEye disorders | 6/111 | 2/109 | 1/112 |
| NasopharyngitisInfections and infestations | 6/111 | 3/109 | 3/112 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 5/111 | 4/109 | 1/112 |
| Cataract nuclearEye disorders | 5/111 | 4/109 | 0/112 |
| Acute sinusitisInfections and infestations | 5/111 | 2/109 | 4/112 |
| HeadacheNervous system disorders | 2/111 | 3/109 | 1/112 |
| DizzinessNervous system disorders | 0/111 | 3/109 | 0/112 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/111 | 3/109 | 0/112 |
| InfluenzaInfections and infestations | 3/111 | 0/109 | 3/112 |
| Age, Categorical(Participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 95 | 93 | 89 | 277 |
| >=65 years | 16 | 16 | 23 | 55 |
| Age, Continuous(years) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 48.4 ± 13.85 | 49.6 ± 13.49 | 49.2 ± 15.26 | 49.1 ± 14.19 |
| Sex: Female, Male(Participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Female | 47 | 43 | 51 | 141 |
| Male | 64 | 66 | 61 | 191 |
| Ethnicity (NIH/OMB)(Participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 9 | 8 | 18 |
| Not Hispanic or Latino | 110 | 100 | 104 | 314 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 1 | 5 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 4 | 6 | 20 |
| White | 99 | 99 | 101 | 299 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 2 |
| Region of Enrollment(participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Canada | 2 | 7 | 7 | 16 |
| Sweden | 2 | 4 | 2 | 8 |
| United States | 62 | 64 | 57 | 183 |
| Poland | 33 | 25 | 32 | 90 |
| United Kingdom | 0 | 1 | 1 | 2 |
| Georgia | 2 | 0 | 0 | 2 |
| Bulgaria | 2 | 3 | 2 | 7 |
| Russia | 8 | 5 | 11 | 24 |
| Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years(participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Mometason Furoate | 44 | 51 | 48 | 143 |
| Fluticasone proprionate | 62 | 66 | 67 | 195 |
| Fluticasone Furoate | 12 | 14 | 20 | 46 |
| Budesonide | 18 | 22 | 18 | 58 |
| Ciclesonide | 1 | 1 | 2 | 4 |
| Beclomethasone | 2 | 7 | 9 | 18 |
| Triamcinolone | 14 | 11 | 16 | 41 |
| Flunisolide | 0 | 0 | 1 | 1 |
| Fluticasone and azelastine | 15 | 14 | 17 | 46 |
| Other | 6 | 3 | 4 | 13 |
| Any Treatment | 100 | 100 | 104 | 304 |
| Prior Sinusitis Surgery(participants) | OPN-375 186 μg BID | OPN-375 372 μg BID | Placebo | Total |
|---|---|---|---|---|
| Any surgery | 58 | 53 | 58 | 169 |
| Endoscopic sinus surgery | 52 | 47 | 48 | 147 |
| Balloon sinuplasty | 5 | 4 | 5 | 14 |
| Polypectomy alone | 14 | 12 | 21 | 47 |
| Other surgery | 5 | 2 | 3 | 10 |
| Sinus stent | 2 | 2 | 8 | 12 |
| Propel mometasone furoate implant | 2 | 2 | 8 | 12 |
| Sinuva mometasone furoate sinus implant : Yes | 1 | 0 | 0 | 1 |
3 further baseline measures are reported on the registry.
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