Project Details
Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Layman's description
The primary objective of this study is to describe the treatments patterns of severe asthmatic patients across four Gulf countries during the past year.
Secondary Objectives
1- To determine the current level of asthma control in these patients. In addition, a comparison of uncontrolled asthma between those with a eosinophilic count ≥ 300 cell/μl and those with an elevated eosinophilic count less than that.
2- To determine the current and past year levels of blood eosinophils, and the percentage of patients with elevated eosinophilic level ≥ 150 cells/μL and ≥ 300 cells/μL
3- To describe the frequency of exacerbations during the past year.
4- To assess the current quality of life (QoL) of these patients.
5- To determine the past year levels of serum IgE.
6- Exploratory objective: To determine the past year levels of other inflammatory biomarkers like periostin and fraction of exhaled nitric oxide (FeNO).
Secondary Objectives
1- To determine the current level of asthma control in these patients. In addition, a comparison of uncontrolled asthma between those with a eosinophilic count ≥ 300 cell/μl and those with an elevated eosinophilic count less than that.
2- To determine the current and past year levels of blood eosinophils, and the percentage of patients with elevated eosinophilic level ≥ 150 cells/μL and ≥ 300 cells/μL
3- To describe the frequency of exacerbations during the past year.
4- To assess the current quality of life (QoL) of these patients.
5- To determine the past year levels of serum IgE.
6- Exploratory objective: To determine the past year levels of other inflammatory biomarkers like periostin and fraction of exhaled nitric oxide (FeNO).
| Acronym | SevEos |
|---|---|
| Status | Finished |
| Effective start/end date | 31/12/17 → 3/01/19 |
Collaborative partners
- AstraZeneca (lead)
Keywords
- Bronchial Diseases
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Immune System Diseases
- Asthma
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