Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma

NCT03825302 | Withdrawn

• 1 other identifier: PGE2 in asthma
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males

  Males only

  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

  Baseline

Study Arms (2)

Males with asthma

Induced sputum, methacholine challenge, and mannitol challenge will be performed.

Diagnostic Test: Methacholine challenge; Diagnostic Test: Mannitol challenge

Females with asthma

Induced sputum, methacholine challenge, and mannitol challenge will be performed.

Diagnostic Test: Methacholine challenge; Diagnostic Test: Mannitol challenge

Interventions

Methacholine challenge DIAGNOSTIC_TEST

Methacholine inhalation challenge will be administered to both male and females with asthma

Females with asthma; Males with asthma

Mannitol challenge DIAGNOSTIC_TEST

Mannitol inhalation challenge will be administered to both male and females with asthma

Females with asthma; Males with asthma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asthmatics at VUMC

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, blood, nasal fluid, urine

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

Study Officials

• Katherine Cahill, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: January 31, 2019
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)