AsthmaNCT06578169
Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
An observational study of Asthma, run by Copenhagen University Hospital, Hvidovre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Hormonal Therapy Agent
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women aged 18 to 75 years
- Planning to initiate HRT/HC within next 30 days
Who cannot join
- Gynecological, endocrinological or other disease affecting the ovarian cycle
- FEV1 < 60% of expected or < 1.5L
- Current hormonal medication
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Asthma
- Being tested
- Hormonal Therapy Agent
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal Therapy AgentDrug
Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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),
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 30 to 14 days before initiation of HC/HRT and 7-14 days and 42-56 days following initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Soren Halvard Hansen, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578169
- Sponsor's protocol ID
- H-23029543
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06578169
- Acronym / sponsor ID
- H-23029543
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Women aged 18 to 75 years
- Planning to initiate HRT/HC within next 30 days
Key exclusion criteria (4 listed)
- Gynecological, endocrinological or other disease affecting the ovarian cycle
- FEV1 < 60% of expected or < 1.5L
- Current hormonal medication
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal Therapy AgentWomen initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause | Drug | – |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Copenhagen University Hospital, Hvidovre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik SH Hansen, MD, PHD (38623862, erik.soeren.halvard.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.