Planned dosing schedule for study drug, no. NSAID-exacerbated respiratory disease (AERD), no. Results Study disposition, baseline demographics, and clinical characteristics of patients P values for between-group differences in proportions were derived from a Wald chi-square test of the treatment effect coefficient in the logistic regression model. The between-group differences in the proportion of patients with comorbid asthma by week 24 was estimated by using a logistic regression model analysis adjusted for baseline covariates (see earlier) and baseline AQLQ score. The between-group difference in the proportion of patients requiring rescue treatment by week 24 was estimated by using a logistic regression model analysis for oral corticosteroid use for 3 or more consecutive days and/or sinus surgery adjusted for baseline covariates (see earlier). The between-group difference in the proportion of patients at week 24 with reduced need for surgery was estimated by using a logistic regression model analysis adjusted for the aforementioned baseline covariates, baseline NPS, and SNOT-22 score. P values were derived from a t test of difference in LSMs. The within-group means and between-group differences in absolute change from baseline to week 24 were the estimated least squares means (LSMs) obtained by using a mixed-effect model with repeated measures with unstructured covariance matrix, adjusted for comorbid asthma/aspirin sensitivity, geographic region, time point per schedule of assessments, baseline outcome score, treatment by time point interaction, and baseline outcome score by time point interaction for NCS, UPSIT score, SNOT-22 score, and TNSS. All 95% CIs are unadjusted for multiplicity. Sequential testing type 1 error control procedures are described in the section Methods E1. Patient demographic and clinical characteristics and efficacy end points were evaluated by using the FAS. Safety and tolerability results were described for the FAS by using summary statistics. Randomized patients were treated with the study drug both analysis sets were identical in POLYP 1 and differed by 1 patient in POLYP 2. The safety analysis set included all patients who received at least 1 dose of study drug according to treatment received.
CPE 555 STEVENS FULL
The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug according to assigned treatment group.
Adverse events (AEs) and concomitant medications were monitored throughout treatment and safety follow-up. In patients with comorbid asthma, the Asthma Quality of Life Questionnaire (AQLQ) was administered at day 1 and at weeks 16 and 24 (point range, 1-7, with higher scores indicating better QoL). SNOT-22 score was measured at screening on day 1 and at weeks 4, 8, 16, and 24 (point range, 0-110, with lower scores indicating better disease control and QoL). The University of Pennsylvania Smell Identification Test (UPSIT) was performed at day 1 and at weeks 8, 16, and 24 (point range, 0-40, with higher scores indicating better smell). NPS (point range, 0-8 to 3 ) each component was analyzed separately and in a combined summed Total Nasal Symptom Score (TNSS) (point range, 0-12 [see Table E3 in this article’s Online Repository at The nasal congestion question forms the NCS.
Serum IgE levels were determined at baseline. Blood samples were collected at screening and at weeks 16, 24, and 28 for routine analyses. A Nasal Congestion Score (NCS) of 2 or higher (with additional symptoms of postnasal drip, runny nose, and/or loss of sense of smell) at day –35 (1-week recall) and a weekly mean NCS higher than 1 at randomization (assessed every morning via an eDiary) were required (see the section Methods E1 in this article’s Online Repository at Patients were required to have a Sino-Nasal Outcome Test-22 (SNOT-22) score of 20 or higher at day –35 and randomization.ĭemographic data and medical history were collected during screening visit 1. Patients were further required to have an NPS of 5 or higher at screening visit 2 (day –7), after 4 weeks of intranasal mometasone during run-in (200 μg twice daily or 200 μg daily if unable to tolerate 200 μg twice daily). Patients were required to have received at least 4 weeks of INCS therapy before screening visit 1 and have a total NPS of 5 or higher (NPS ≥2 for each nostril) at screening visit 1 (day –35). Patients aged 18-75 years with persistent bilateral nasal polyps, nasal congestion, impaired HRQoL, and weight and serum IgE level permitting omalizumab dosing per Table E1 (in this article’s Online Repository at (ie, weight of 30-50 kg and serum IgE level of 30-1500 IU/mL) were eligible. Diversity, Equity, and Inclusion Initiatives.
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