ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03825302
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Cahill, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment
Asthma Diagnostic Test: Methacholine challenge Diagnostic Test: Mannitol challenge

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Males with asthma
Induced sputum, methacholine challenge, and mannitol challenge will be performed.
Diagnostic Test: Methacholine challenge
Methacholine inhalation challenge will be administered to both male and females with asthma

Diagnostic Test: 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.
Diagnostic Test: Methacholine challenge
Methacholine inhalation challenge will be administered to both male and females with asthma

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




Primary Outcome Measures :
  1. Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males [ Time Frame: Baseline ]
    Males only

  2. 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


Biospecimen Retention:   Samples With DNA
Sputum, blood, nasal fluid, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asthmatics at VUMC
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825302


Contacts
Contact: Katherine Cahill, MD 615-936-2898 katherine.cahill@vumc.org

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Katherine Cahill, MD Vanderbilt University Medical Center

Responsible Party: Katherine Cahill, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03825302     History of Changes
Other Study ID Numbers: PGE2 in asthma
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mannitol
Methacholine Chloride
Dinoprostone
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Oxytocics
Reproductive Control Agents