Clinical trial NCT06578169: Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
Official title: Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of this study will be women aged 18 to 75 years who for any reason are about to initiate HRT/HC. Further, patients must not be on any hormonal treatment at the time of initiation of hormones and must not have any gynecological or endocrinological disorder which is known to affect the ovarian cycle.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 to 75 years
* Planning to initiate HRT/HC within next 30 days

Exclusion Criteria:

* Gynecological, endocrinological or other disease affecting the ovarian cycle
* FEV1 \< 60% of expected or \< 1.5L
* Current hormonal medication
* Pregnancy

Primary outcomes:
measure: Airway responsiveness to methacholine
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
Secondary outcomes:
measure: Changes in lung function measured as forced expiratory volume in first second (FEV1), forced vital capacity (FVC),
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Change from baseline as measured by airway oscillometry (AOS)
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Changes in airway inflammation measured as FeNO
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: 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)
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Medical Research Council Dyspnea Scale (MRC) will be used to evaluate subjective dyspnea. MRC will be evaluated by medical interview.
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Changes in allergy measured as skin prick test (SPT) to common inhaled allergens
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Changes in body composition - fat distribution
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Changes in body composition measured as fat percent
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Changes in body composition measured as fat mass (kg)
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
measure: Baseline Dyspnea Index (BDI) will be used to evaluate subjective dyspnea. Will be evaluated by medical interview.
timeFrame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
Other outcomes:
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