Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma

Vanderbilt University Medical Center1 site in 1 countryDecember 1, 2021

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: Vanderbilt University Medical Center
Locations: 1
Primary Endpoint: Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

December 1, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Vanderbilt University Medical Center

Responsible Party

Principal Investigator

Katherine Cahill

Assistant Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.