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Not yet recruiting NCT06578169

Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study

— Observational Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hormonal Therapy Agent.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Hormonal Therapy Agent
    Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause

Primary outcome measures

  • Airway responsiveness to methacholine [Time frame: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation]
Secondary outcome measures (10)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06578169 · H-23029543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗