Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Airway responsiveness to methacholine
研究概览
简要总结
The project aims to investigate the effect of female sex hormone treatment (both contraceptive treatment and hormone therapy during menopause) on bronchial hyperreactivity in adult women. The study is a prospective cohort study involving 300 women, examining airway responsiveness before and after the initiation of hormone treatment, whether as hormone therapy in menopause or contraceptive treatment. Participants will be recruited from general practitioners in the Capital Region of Denmark. Lung function, bronchial hyperreactivity, airway inflammation, and body composition will be assessed before and after hormone treatment. Blood samples will also be collected and stored for later analysis of inflammation markers. The study will include women aged 18 to 75 who are about to begin hormone treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years
- •Planning to initiate HRT/HC within next 30 days
排除标准
- •Gynecological, endocrinological or other disease affecting the ovarian cycle
- •FEV1 < 60% of expected or < 1.5L
- •Current hormonal medication
- •Pregnancy
结局指标
主要结局
Airway responsiveness to methacholine
时间窗: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
Airway responsiveness to methacholine challenge before and after initiation of HC/HRT treatment reported as a dose-response-ratio defined as change in %FEV1 per μmol
次要结局
- Changes in lung function measured as forced expiratory volume in first second (FEV1), forced vital capacity (FVC),(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Change from baseline as measured by airway oscillometry (AOS)(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in airway inflammation measured as FeNO(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in blood alarmins such as blood eosinophils, interleukin 4 (IL-4), IL-5, IL-6, IL-8, IL-10, IL-13, IL-17, IL-23, IL-33, TSLP, IL-1 and Tumor Necrosis Factor alfa (TNF-alfa)(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Medical Research Council Dyspnea Scale (MRC) will be used to evaluate subjective dyspnea. MRC will be evaluated by medical interview.(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in allergy measured as skin prick test (SPT) to common inhaled allergens(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in body composition - fat distribution(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in body composition measured as fat mass (kg)(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Changes in body composition measured as fat percent(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
- Baseline Dyspnea Index (BDI) will be used to evaluate subjective dyspnea. Will be evaluated by medical interview.(30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation)
研究者
Erik Soren Halvard Hansen
Principal Investigator
Copenhagen University Hospital, Hvidovre