Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03478930) enrolled 249 adults with nasal polyps — 126 who had previously received a placebo in earlier related studies, and 123 who had previously received omalizumab (an injectable medicine). The trial was measuring several things over 24 weeks: the size of nasal polyps (scored on a scale of 0–8), the severity of nasal congestion (scored 0–3 daily by participants), overall nasal symptoms combined into a total score (0–12), and reduced sense of smell (scored 0–3). The trial also tracked how many participants experienced unwanted health events (called adverse events) during the study. The reported data shows that, for nasal polyp size, the placebo group's score changed by around −0.97 points by the final recorded time point, while the omalizumab group's score changed by around −1.31 points (both reductions from their starting scores, on the 0–8 scale). For nasal congestion (0–3 scale), the reported change was approximately −0.31 points in the placebo group and −0.85 points in the omalizumab group at the final time point. For the combined nasal symptom score (0–12 scale), the placebo group's score changed by roughly −0.92 points and the omalizumab group's by roughly −2.82 points. For reduced sense of smell (0–3 scale), the reported changes were approximately −0.23 and −0.56 points respectively. Regarding unwanted health events, the reported data shows that 49.6% of the placebo group and 43.5% of the omalizumab group experienced at least one adverse event, while serious adverse events were reported in 4.8% of the placebo group and 2.4% of the omalizumab group. Less than 1% of participants in either group stopped the study due to an adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38197558) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Chronic Rhinosinusitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be able to follow the study rules and schedule, as decided by the study doctor.
- You must have already been taking part in a related study (GA39688 or GA39855), completed an endoscopy, and finished all required check-ups at the 24-week point — without stopping the study medication early.
- You must have completed your daily electronic diary on at least 4 out of 7 days in the week before your 24-week visit in the previous study.
- If you are a woman who could become pregnant, you must agree to either avoid sexual intercourse or use an approved form of contraception during the study and for 60 days after your last dose of the study drug.
Who may not be able to join:
- You may not be eligible if you had a severe allergic reaction to the study drug during the previous related study.
- You may not be eligible if you had serious side effects from the study drug in the previous related study that the doctor believes could put your safety at risk if you continue.
- You may not be eligible if you had uncontrolled nosebleeds during the previous related study.
- You may not be eligible if you are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 60 days of your last dose of the study drug.
- You may not be eligible if you have a serious health condition or abnormal lab test results that the study doctor believes would make it unsafe for you to participate.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change From Baseline in Nasal Polyp Score (NPS); Change From Baseline in Average Daily Nasal Congestion Score (NCS); Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE); Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.