AsthmaNCT03825302
Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma
An observational study of Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine challenge and Mannitol challenge
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Asthmatics at VUMC
Who may be able to join
- Subject must be able to understand and provide informed consent
- Age 18-50
- A history of physician-diagnosed asthma well controlled as assessed by ACQ-6 <1.5 and FEV1>70% of predicted and FEV1 >1.5 liters.
- Asthma must be persistent, defined by the requirement of a daily controller agent.
- Use of a stable dose of daily inhaled corticosteroids for the prior 3 months.
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry and at each study visit.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (PCOS), exogenous hormonal supplements or contraception.
- Any chronic lung condition outside of asthma including chronic obstructive pulmonary disease (COPD), interstitial lung disease, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis.
- Inability or unwillingness to hold the following medications prior to mannitol and methacholine inhalational challenge(s): Short-Acting Beta 2 Agonists >8 hours, Inhaled Corticosteroids and Anticholinergic Bronchodilators >12 hours, Phosphodiesterase Inhibitors or Adenosine Receptors >24 hours, Long-acting Beta 2 Agonists >36 hours, Long-acting Anticholinergics or Short-Acting Antihistamines >48 hours, Long-Acting Antihistamines >72 hours, and Leukotriene-Receptor Antagonist or 5-Lipooxygenase Inhibitors >4 days.
- For males, a screening morning serum total testosterone level (obtained between 8-10 AM) below the normal reference lab value.
- Current pregnancy, breast-feeding, or plans to become pregnant during the study period.
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- Oral or systemic corticosteroid use or biologic agent for asthma in the previous 3 months or ED/Hospitalization for asthma within 6 months.
- Use of investigational drugs within 12 weeks of participation.
- Known hypersensitivity or allergy to mannitol, gelatin or methacholine.
- Upper or lower respiratory tract infection within the proceeding 6 weeks.
- A history of uncontrolled hypertension, coronary artery disease, stroke, epilepsy, urinary tract obstruction, untreated thyroid disease, or a chronic lung disease other than asthma.
- Daily use of a beta-blocker.
- Intolerance to anticholinergic medications.
- Inability to produce an adequate sputum sample.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.
- Conditions
- Asthma
- Being tested
- Methacholine challenge, Mannitol challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine challengeDiagnostic test
Methacholine inhalation challenge will be administered to both male and females with asthma
Mannitol challengeDiagnostic test
Mannitol inhalation challenge will be administered to both male and females with asthma
| Study group | Role | What they receive |
|---|---|---|
| Males with asthma | Induced sputum, methacholine challenge, and mannitol challenge will be performed. Receives: Diagnostic Test: Methacholine challenge; Diagnostic Test: Mannitol challenge | |
| Females with asthma | Induced sputum, methacholine challenge, and mannitol challenge will be performed. Receives: Diagnostic Test: Methacholine challenge; Diagnostic Test: Mannitol challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males
Males only
Measured: Baseline
Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in females
Females only during the luteal phase of the menstrual cycle
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: No funding available.
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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Cahill, Vanderbilt University Medical Center
- Investigators
- Katherine Cahill, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825302
- Sponsor's protocol ID
- PGE2 in asthma
- Status last verified
- Mar 2022
- First submitted
- 30 Jan 2019
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma
- ClinicalTrials.gov ID
- NCT03825302
- Acronym / sponsor ID
- PGE2 in asthma
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 31 Jan 2019 (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.
This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males with asthma | – | Diagnostic Test: Methacholine challenge, Diagnostic Test: Mannitol challengeInduced sputum, methacholine challenge, and mannitol challenge will be performed. |
| Females with asthma | – | Diagnostic Test: Methacholine challenge, Diagnostic Test: Mannitol challengeInduced sputum, methacholine challenge, and mannitol challenge will be performed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Asthmatics at VUMC
Key inclusion criteria (6 listed)
- Subject must be able to understand and provide informed consent
- Age 18-50
- A history of physician-diagnosed asthma well controlled as assessed by ACQ-6 <1.5 and FEV1>70% of predicted and FEV1 >1.5 liters.
- Asthma must be persistent, defined by the requirement of a daily controller agent.
- Use of a stable dose of daily inhaled corticosteroids for the prior 3 months.
Key exclusion criteria (15 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (PCOS), exogenous hormonal supplements or contraception.
- Any chronic lung condition outside of asthma including chronic obstructive pulmonary disease (COPD), interstitial lung disease, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis.
- Inability or unwillingness to hold the following medications prior to mannitol and methacholine inhalational challenge(s): Short-Acting Beta 2 Agonists >8 hours, Inhaled Corticosteroids and Anticholinergic Bronchodilators >12 hours, Phosphodiesterase Inhibitors or Adenosine Receptors >24 hours, Long-acting Beta 2 Agonists >36 hours, Long-acting Anticholinergics or Short-Acting Antihistamines >48 hours, Long-Acting Antihistamines >72 hours, and Leukotriene-Receptor Antagonist or 5-Lipooxygenase Inhibitors >4 days.
- For males, a screening morning serum total testosterone level (obtained between 8-10 AM) below the normal reference lab value.
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 |
|---|---|---|
| Methacholine challengeMethacholine inhalation challenge will be administered to both male and females with asthma | Diagnostic test | Females with asthma, Males with asthma |
| Mannitol challengeMannitol inhalation challenge will be administered to both male and females with asthma | Diagnostic test | Females with asthma, Males with asthma |
Primary outcome
Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males
Time frame: Baseline
Males only
Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in females
Time frame: Baseline
Females only during the luteal phase of the menstrual cycle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- 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. This study is not recruiting at the moment.
Katherine Cahill, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males (time frame: Baseline). The study lists 2 primary outcomes in all. 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 17 Mar 2022.