Trial · NCT04157335
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56 | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| PRIMARY | Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56. | Baseline to week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| SECONDARY | Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56. | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| SECONDARY | Sinus Opacification by CT Scan at Week 56. | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| SECONDARY | Disease Specific Health-related Quality of Life (HRQoL): Change From Baseline in SinoNasal Outcome Test (SNOT-22) Score at Week 56. | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| SECONDARY | Time to First Nasal Polyp Surgery | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Months | MEDIAN |
| SECONDARY | Time to First SCS Course for CRSwNP | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Months | MEDIAN |
| SECONDARY | Time to First NP Surgery and/or SCS Use for CRSwNP | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Months | MEDIAN |
| SECONDARY | Change From Baseline in Bi-weekly Mean Nasal Polyps Symptom Diary Total Symptom Score at Week 56. | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP. | Score | MEAN |
| SECONDARY | Percentage of Participants With Surgery and/or Use SCS for CRSwNP | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Surgery for CRSwNP | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With SCS Use for CRSwNP | Baseline to Week 56 | Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04157335/outcomes