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

ConditionAsthma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorCopenhagen University Hospital, Hvidovre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 to 75 years

Planning to initiate HRT/HC within next 30 days

Disqualifiers

Gynecological, endocrinological or other disease affecting the ovarian cycle

FEV1 < 60% of expected or < 1.5L

Current hormonal medication

Pregnancy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hormonal Therapy Agent

    Drug

    Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen University Hospital, Hvidovre

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: