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

August 27, 2024 updated by: Erik Soren Halvard Hansen, Copenhagen University Hospital, Hvidovre
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • H-23029543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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