Trial · NCT03280550
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 |
| SECONDARY | 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 | Baseline, Week 24 | Analysis was conducted only in the subgroup of participants with comorbid asthma at screening and AQLQ assessments at Baseline and Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Rescue Treatment (Systemic Corticosteroids For ≥3 Consecutive Days or 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 |
| SECONDARY | 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 | Up to 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) 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 Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) 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 | Number of Participants Who Experienced at Least One Adverse Event by Greatest Severity | Up to Week 28 | Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Serious Adverse Event | Up to Week 28 | Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation | Up to Week 24 | Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities by Highest Grade Post-Baseline | Up to Week 28 | Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Concentration of Omalizumab at Specified Timepoints | Predose on Day 1, Week 16, Week 24, Unscheduled Visit (outside of planned study visits, as clinically indicated), Dosing Termination/Early Termination Visit (up to 28 weeks) | Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. Only the omalizumab-treated participants with evaluable samples at each timepoint were included in this analysis. | nanograms per millilitre (ng/mL) | MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT03280550/outcomes