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.
Study Type
OBSERVATIONAL
Enrollment
300
Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause
Airway responsiveness to methacholine
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
Time frame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
Changes in lung function measured as forced expiratory volume in first second (FEV1), forced vital capacity (FVC),
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
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