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

NCT06578169 | Not Yet Recruiting

• 1 other identifier: H-23029543
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

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

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

Secondary Outcomes (10)

• Changes in lung function measured as forced expiratory volume in first second (FEV1), forced vital capacity (FVC),

  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)

  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

  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)

  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.

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

Interventions

Hormonal Therapy Agent DRUG

Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Erik SH Hansen, MD, PHD

CONTACT

38623862; erik.soeren.halvard.hansen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 29, 2024

Record last verified: 2024-08