Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma
NCT ID: NCT03825302
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-12-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Males with asthma
Induced sputum, methacholine challenge, and mannitol challenge will be performed.
Methacholine challenge
Methacholine inhalation challenge will be administered to both male and females with asthma
Mannitol challenge
Mannitol inhalation challenge will be administered to both male and females with asthma
Females with asthma
Induced sputum, methacholine challenge, and mannitol challenge will be performed.
Methacholine challenge
Methacholine inhalation challenge will be administered to both male and females with asthma
Mannitol challenge
Mannitol inhalation challenge will be administered to both male and females with asthma
Interventions
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Methacholine challenge
Methacholine inhalation challenge will be administered to both male and females with asthma
Mannitol challenge
Mannitol inhalation challenge will be administered to both male and females with asthma
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Katherine Cahill
Assistant Professor
Principal Investigators
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Katherine Cahill, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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PGE2 in asthma
Identifier Type: -
Identifier Source: org_study_id
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