Trial · NCT01066104
Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
NCT01066104, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis. Trials, record NCT01066104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01066104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
- NCT number
- NCT01066104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Chronic Rhinosinusitis, Nasal Polyps
- Interventions
- Xolair placebo, Xolair (omalizumab)
- First posted
- 2010-02-10
- Last updated
- 2017-06-14
- Results first posted
- 2017-05-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan. | 4 months | Improvement is defined as any decrease in sinus CT scores at end of study. Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable): A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient's head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans will be scored using the established scoring system known as the Zinreich modification of the Lund Mackay scoring system.. As an exploratory measure, a 3-dimensional scoring system developed with the radiology department of Massachusetts General Hospital may also be used. |
| Secondary | Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination. | 4 months | Improvement is defined as any reduction in the total nasal polyp score. Using rhinoscopic evaluation, Nasal Polyp Score will be assessed on the right and on the left, and added together. Scoring system: Score Definition 0 No polyps 1. Polyp in middle meatus, not reaching below the inferior border of the middle turbinate 2. Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate 3. Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate 4. Polyp reaching to or below the lower border of the inferior turbinate Range: minimum 0 (better outcome), maximum 8 (worse outcome) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan. | 4 months | % Change | MEAN | |
| SECONDARY | Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination. | 4 months | Change in Total polyp score | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan. | Xolair Placebo | -8.9 | Standard Deviation 28.2 | % Change | |
| Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan. | Xolair (Omalizumab) | 4.2 | Standard Deviation 25.6 | % Change | |
| Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination. | Xolair Placebo | .05 | Standard Deviation 2.27 | Change in Total polyp score | |
| Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination. | Xolair (Omalizumab) | -0.33 | Standard Deviation 2.1 | Change in Total polyp score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xolair Placebo | 14 | |
| Overall Study | STARTED | Xolair (Omalizumab) | 13 | |
| Overall Study | COMPLETED | Xolair Placebo | 12 | |
| Overall Study | COMPLETED | Xolair (Omalizumab) | 12 | |
| Overall Study | NOT COMPLETED | Xolair Placebo | 2 | |
| Overall Study | NOT COMPLETED | Xolair (Omalizumab) | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Hair thinning | Skin and subcutaneous tissue disorders | Xolair Placebo | 0 | 14 | 0 |
| other | Hair thinning | Skin and subcutaneous tissue disorders | Xolair (Omalizumab) | 1 | 13 | 1 |
| other | Bilateral hilar adenopathy | Blood and lymphatic system disorders | Xolair Placebo | 1 | 14 | 1 |
| other | Bilateral hilar adenopathy | Blood and lymphatic system disorders | Xolair (Omalizumab) | 0 | 13 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xolair Placebo | 0 | 14 |
| Total, all-cause mortality | Xolair (Omalizumab) | 0 | 13 |
| Total, other adverse events | Xolair Placebo | 1 | 14 |
| Total, other adverse events | Xolair (Omalizumab) | 1 | 13 |
| Total, serious adverse events | Xolair Placebo | 0 | 14 |
| Total, serious adverse events | Xolair (Omalizumab) | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Xolair (Omalizumab) vs Xolair Placebo: deaths from any cause | Trial comparisons |
| Xolair (Omalizumab) vs Xolair 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/NCT01066104
GET https://conductscience.org/api/trials/v1/NCT01066104/registered