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NCT Number: NCT06578169

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hormonal Therapy Agent

Drug

Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Erik SH Hansen, MD, PHD

CONTACT

[email protected]

38623862

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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