Trial · NCT03280550
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
NCT03280550, Phase 3, Completed, Hoffmann-La Roche; results first posted 2020-03-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps. Trials, record NCT03280550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03280550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- NCT number
- NCT03280550
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 138 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Nasal Polyps, Chronic Rhinosinusitis
- Interventions
- Omalizumab, Placebo
- First posted
- 2017-09-12
- Last updated
- 2020-03-23
- Other registries' IDs
- eudract:2017-001724-22
- Results first posted
- 2020-03-23
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Nasal Polyp Score (NPS) at Week 24 | Baseline, Week 24 | Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers. |
| Primary | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization. |
| Secondary | Change From Baseline in Average Daily Sense of Smell Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | The Sense of Smell Score was assessed daily by the participant via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization. |
| Secondary | Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | The Posterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization. |
| Secondary | Change From Baseline in Nasal Polyp Score (NPS) at Week 16 | Baseline, Week 16 | Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers. |
| Secondary | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 16 | Baseline, Week 16 (Study Days 99 to 126) | The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options, scored from 0 (no symptoms) to 3 (severe symptoms) were: 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 16: Study Days 99 to 126), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 112), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization. |
| Secondary | Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Questionnaire at Week 24 | Baseline, Week 24 | The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score. |
| Secondary | Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | The Anterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization. |
| Secondary | Number of Participants Requiring Rescue Medication (Systemic Corticosteroids for ≥3 Consecutive Days) Through Week 24 | Up to Week 24 | A participant was considered to have had the event of requiring rescue medication if they had taken systemic corticosteroids for 3 or more consecutive days at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not taken systemic corticosteroids for 3 or more consecutive days, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used. |
| Secondary | Number of Participants Having Had Surgery for Nasal Polyps Through Week 24 | Up to Week 24 | A participant was considered to have had the event of surgery for nasal polyps if they underwent the procedure at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not undergone surgery for nasal polyps, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Nasal Polyp Score (NPS) at Week 24 | Baseline, Week 24 | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Daily Sense of Smell Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Polyp Score (NPS) at Week 16 | Baseline, Week 16 | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 16 | Baseline, Week 16 (Study Days 99 to 126) | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Questionnaire at Week 24 | Baseline, Week 24 | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24 | Baseline, Week 24 (Study Days 155 to 186) | Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Requiring Rescue Medication (Systemic Corticosteroids for ≥3 Consecutive Days) Through Week 24 | Up to Week 24 | Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Having Had Surgery for Nasal Polyps Through Week 24 | Up to Week 24 | Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Nasal Polyp Score (NPS) at Week 24 | Placebo | 0.06 | 95% Confidence Interval -0.27 to 0.38 | Score on a scale | |
| Change From Baseline in Nasal Polyp Score (NPS) at Week 24 | Omalizumab | -1.08 | 95% Confidence Interval -1.40 to -0.77 | Score on a scale | |
| Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 | Placebo | -0.35 | 95% Confidence Interval -0.56 to -0.13 | Score on a scale | |
| Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 | Omalizumab | -0.89 | 95% Confidence Interval -1.10 to -0.69 | Score on a scale | |
| Change From Baseline in Average Daily Sense of Smell Score at Week 24 | Placebo | -0.23 | 95% Confidence Interval -0.42 to -0.04 | Score on a scale | |
| Change From Baseline in Average Daily Sense of Smell Score at Week 24 | Omalizumab | -0.56 | 95% Confidence Interval -0.74 to -0.38 | Score on a scale | |
| Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24 | Placebo | -0.16 | 95% Confidence Interval -0.36 to 0.04 | Score on a scale | |
| Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24 | Omalizumab | -0.72 | 95% Confidence Interval -0.91 to -0.53 | Score on a scale | |
| Change From Baseline in Nasal Polyp Score (NPS) at Week 16 | Placebo | 0.03 | 95% Confidence Interval -0.27 to 0.33 | Score on a scale | |
| Change From Baseline in Nasal Polyp Score (NPS) at Week 16 | Omalizumab | -0.98 | 95% Confidence Interval -1.27 to -0.70 | Score on a scale |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | STARTED | Omalizumab | 72 | |
| Overall Study | COMPLETED | Placebo | 64 | |
| Overall Study | COMPLETED | Omalizumab | 69 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Omalizumab | 3 |
Source ClinicalTrials.gov
Adverse events10
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 | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 10 | 66 | 12 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Omalizumab | 3 | 72 | 4 |
| other | Headache | Nervous system disorders | Placebo | 4 | 66 | 5 |
| other | Headache | Nervous system disorders | Omalizumab | 4 | 72 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 66 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Omalizumab | 2 | 72 | 2 |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 66 | 1 |
| other | Sinusitis | Infections and infestations | Omalizumab | 4 | 72 | 4 |
| serious | Myocardial infarction | Cardiac disorders | Placebo | 1 | 66 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Omalizumab | 0 | 72 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 66 |
| Total, all-cause mortality | Omalizumab | 0 | 72 |
| Total, other adverse events | Placebo | 16 | 66 |
| Total, other adverse events | Omalizumab | 12 | 72 |
| Total, serious adverse events | Placebo | 1 | 66 |
| Total, serious adverse events | Omalizumab | 0 | 72 |
Source ClinicalTrials.gov
Papers6
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omalizumab vs Placebo: Number of Participants Requiring Rescue Medication (Systemic Corticosteroids for ≥3 Consecutive Days) Through Week 24 | Trial comparisons |
| Omalizumab vs Placebo: Number of Participants Who Experienced at Least One Serious Adverse Event | Trial comparisons |
| Omalizumab vs Placebo: Number of Participants Having Had Surgery for Nasal Polyps Through Week 24 | Trial comparisons |
| Omalizumab vs Placebo: Number of Participants Requiring Rescue Treatment (Systemic Corticosteroids For ≥3 Consecutive Days or Having Had Surgery for Nasal Polyps) Through Week 24 | Trial comparisons |
| Omalizumab vs Placebo: Number of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation | Trial comparisons |
| Omalizumab vs Placebo: Number of Participants With a Change From Baseline at Week 24 in Asthma Quality of Life Questionnaire (AQLQ) of ≥0.5 in Participants With Comorbid Asthma Only | Trial comparisons |
| Omalizumab vs Placebo: deaths from any cause | Trial comparisons |
Omalizumab vs Placebo: Number of Participants With Reduction in the Need for Surgery for Nasal Polyps by Week 24, as Defined by an NPS of ≤4 (Unilateral Score of ≤2 on Each Side) and Improvement in SNOT-22 Score of ≥8.9 | Trial comparisons |
| Omalizumab vs Placebo: serious adverse events | Trial comparisons |
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/NCT03280550
GET https://conductscience.org/api/trials/v1/NCT03280550/registered?page=2